A double-blind, randomized, dose-finding study to assess the efficacy of the gonadotrophin-releasing hormone antagonist ganirelix (Org 37462) to prevent premature luteinizing hormone surges in women undergoing ovarian stimulation with recombinant follicle stimulating hormone (Puregon). The ganirelix dose-finding study group.

The source lists no authors.

Human reproduction (Oxford, England)1 Nov 1998Cited by 158 (Europe PMC)

PMID9853849DOI10.1093/humrep/13.11.3023PepBankPUB-09853849

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study24

24 results from studies that gave the peptide. 24 results from people.

01HumanRandomized controlled trialPharmacokinetics
In women undergoing ovarian stimulation, serum ganirelix concentrations increased linearly with dose.
In plain wordsIn women undergoing ovarian stimulation, blood ganirelix levels increased linearly with dose.
Peptide
Ganirelix
Outcome
IncreaseSerum ganirelix concentration
Study
n = 333
Comparator
Other ganirelix dose groups
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg once daily · subcutaneous · approximately 5 daysAs given in this study (human).
Source sentences
Summary
Serum Org 37462 concentrations increased in a linear dose-proportional manner, whereas serum LH and increases of oestradiol fell with increasing Org 37462 dose.
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384902
02HumanRandomized controlled trialEfficacy outcome
In women undergoing ovarian stimulation, serum LH fell with increasing ganirelix dose.
In plain wordsIn women undergoing ovarian stimulation, blood LH decreased as ganirelix dose increased.
Peptide
Ganirelix
Outcome
DecreaseSerum LH dose response
Study
n = 333
Comparator
Other ganirelix dose groups
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg once daily · subcutaneous · approximately 5 daysAs given in this study (human).
Source sentences
Summary
Serum Org 37462 concentrations increased in a linear dose-proportional manner, whereas serum LH and increases of oestradiol fell with increasing Org 37462 dose.
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384903
03HumanRandomized controlled trialEfficacy outcome
In women undergoing ovarian stimulation, estradiol increases fell with increasing ganirelix dose.
In plain wordsIn women undergoing ovarian stimulation, estradiol increases became smaller as ganirelix dose increased.
Peptide
Ganirelix
Outcome
DecreaseEstradiol increase dose response
Study
n = 333
Comparator
Other ganirelix dose groups
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg once daily · subcutaneous · approximately 5 daysAs given in this study (human).
Source sentences
Summary
Serum Org 37462 concentrations increased in a linear dose-proportional manner, whereas serum LH and increases of oestradiol fell with increasing Org 37462 dose.
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384904
04HumanRandomized controlled trialEfficacy outcome
In women undergoing ovarian stimulation, follicles at least 11 mm were similar across six ganirelix dose groups on HCG day.
In plain wordsIn women undergoing ovarian stimulation, follicles at least 11 mm were similar across ganirelix doses on HCG day.
Peptide
Ganirelix
Outcome
Direction not reportedFollicles at least 11 mm
Study
n = 333
Comparator
Other ganirelix doses
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg once daily · subcutaneous · approximately 5 daysAs given in this study (human).
Source sentences
Summary
On the day of HCG, the number of follicles > or =11, > or =15 and > or =17 mm were similar in the six dose groups,
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384908
05HumanRandomized controlled trialEfficacy outcome
In women undergoing ovarian stimulation, follicles at least 15 mm were similar across six ganirelix dose groups on HCG day.
In plain wordsIn women undergoing ovarian stimulation, follicles at least 15 mm were similar across ganirelix doses on HCG day.
Peptide
Ganirelix
Outcome
Direction not reportedFollicles at least 15 mm
Study
n = 333
Comparator
Other ganirelix doses
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg once daily · subcutaneous · approximately 5 daysAs given in this study (human).
Source sentences
Summary
On the day of HCG, the number of follicles > or =11, > or =15 and > or =17 mm were similar in the six dose groups,
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384909
06HumanRandomized controlled trialEfficacy outcome
In women undergoing ovarian stimulation, follicles at least 17 mm were similar across six ganirelix dose groups on HCG day.
In plain wordsIn women undergoing ovarian stimulation, follicles at least 17 mm were similar across ganirelix doses on HCG day.
Peptide
Ganirelix
Outcome
Direction not reportedFollicles at least 17 mm
Study
n = 333
Comparator
Other ganirelix doses
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg once daily · subcutaneous · approximately 5 daysAs given in this study (human).
Source sentences
Summary
On the day of HCG, the number of follicles > or =11, > or =15 and > or =17 mm were similar in the six dose groups,
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384910
07HumanRandomized controlled trialEfficacy outcome
In women undergoing ovarian stimulation, mean recovered oocytes were similar across ganirelix doses and ranged from 8.6 to 10.0.
In plain wordsIn women undergoing ovarian stimulation, recovered egg counts were similar across ganirelix doses.
Peptide
Ganirelix
Outcome
Direction not reportedRecovered oocytes
Study
n = 333
Comparator
Other ganirelix doses
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg once daily · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Mean recovered oocytes
8.6 to 10 oocytes
across dose groups
Source sentences
Summary
The mean number of recovered oocytes and good-quality embryos was similar in all dose groups and ranged from 8.6 to 10.0 and 2.5 to 3.8, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384914
08HumanRandomized controlled trialEfficacy outcome
In women undergoing ovarian stimulation, mean good-quality embryos were similar across ganirelix doses and ranged from 2.5 to 3.8.
In plain wordsIn women undergoing ovarian stimulation, good-quality embryo counts were similar across ganirelix doses.
Peptide
Ganirelix
Outcome
Direction not reportedGood-quality embryos
Study
n = 333
Comparator
Other ganirelix doses
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg once daily · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Mean good-quality embryos
2.5 to 3.8 embryos
across dose groups
Source sentences
Summary
The mean number of recovered oocytes and good-quality embryos was similar in all dose groups and ranged from 8.6 to 10.0 and 2.5 to 3.8, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384915
09HumanRandomized controlled trialEfficacy outcome
In women undergoing ovarian stimulation, estradiol was highest with ganirelix 0.0625 mg at 1475 pg/ml on HCG day.
In plain wordsIn women undergoing ovarian stimulation, estradiol was highest with ganirelix 0.0625 mg compared with other doses.
Peptide
Ganirelix
Outcome
IncreaseEstradiol on HCG day
Study
n: not reported in source
Comparator
Other ganirelix doses
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.0625 mg · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Serum estradiol on HCG day
1475 pg/ml
0.0625 mg group (highest)
Source sentences
Summary
whereas serum oestradiol concentrations were highest in the 0.0625 mg group (1475 pg/ml) and lowest in the 2 mg group (430 pg/ml).
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384911
10HumanRandomized controlled trialEfficacy outcome
In women undergoing ovarian stimulation, estradiol was lowest with ganirelix 2 mg at 430 pg/ml on HCG day.
In plain wordsIn women undergoing ovarian stimulation, estradiol was lowest with ganirelix 2 mg compared with other doses.
Peptide
Ganirelix
Outcome
DecreaseEstradiol on HCG day
Study
n: not reported in source
Comparator
Other ganirelix doses
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
2 mg · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Serum estradiol on HCG day
430 pg/ml
2 mg group (lowest)
Source sentences
Summary
whereas serum oestradiol concentrations were highest in the 0.0625 mg group (1475 pg/ml) and lowest in the 2 mg group (430 pg/ml).
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384912
11HumanRandomized controlled trialEfficacy outcome
In women undergoing ovarian stimulation, implantation was highest with ganirelix 0.25 mg at 21.9%.
In plain wordsIn women undergoing ovarian stimulation, implantation was highest with ganirelix 0.25 mg compared with other doses.
Peptide
Ganirelix
Outcome
IncreaseImplantation rate
Study
n: not reported in source
Comparator
Other ganirelix doses
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.25 mg · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Implantation rate
21.9%
0.25 mg group (highest)
Source sentences
Summary
The implantation rate was highest in the 0.25 mg group (21.9%) and lowest in the 2 mg group (1.5%).
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384917
12HumanRandomized controlled trialEfficacy outcome
In women undergoing ovarian stimulation, implantation was lowest with ganirelix 2 mg at 1.5%.
In plain wordsIn women undergoing ovarian stimulation, implantation was lowest with ganirelix 2 mg compared with other doses.
Peptide
Ganirelix
Outcome
DecreaseImplantation rate
Study
n: not reported in source
Comparator
Other ganirelix doses
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
2 mg · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Implantation rate
1.5%
2 mg group (lowest)
Source sentences
Summary
The implantation rate was highest in the 0.25 mg group (21.9%) and lowest in the 2 mg group (1.5%).
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384918
13HumanRandomized controlled trialEfficacy outcome
In women undergoing ovarian stimulation, vital pregnancy at 5-6 weeks was highest with ganirelix 0.25 mg at 36.8% per attempt.
In plain wordsIn women undergoing ovarian stimulation, vital pregnancy per attempt was highest with ganirelix 0.25 mg compared with other doses.
Peptide
Ganirelix
Outcome
IncreaseVital pregnancy per attempt
Study
n: not reported in source
Comparator
Other ganirelix doses
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.25 mg · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Vital pregnancy rate per attempt
36.8%
0.25 mg group, 5-6 weeks after embryo transfer
Source sentences
Summary
The vital pregnancy rate (with heart activity) at 5-6 weeks after embryo transfer was highest in the 0.25 mg group, i.e. 36.8 % per attempt and 40.3 % per transfer, and resulted in an ongoing pregnancy rate 12-16 weeks after embryo transfer of 33.8% per attempt and 37.1% per transfer.
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384922
14HumanRandomized controlled trialEfficacy outcome
In women undergoing ovarian stimulation, vital pregnancy at 5-6 weeks was highest with ganirelix 0.25 mg at 40.3% per transfer.
In plain wordsIn women undergoing ovarian stimulation, vital pregnancy per transfer was highest with ganirelix 0.25 mg compared with other doses.
Peptide
Ganirelix
Outcome
IncreaseVital pregnancy per transfer
Study
n: not reported in source
Comparator
Other ganirelix doses
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.25 mg · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Vital pregnancy rate per transfer
40.3%
0.25 mg group, 5-6 weeks after embryo transfer
Source sentences
Summary
The vital pregnancy rate (with heart activity) at 5-6 weeks after embryo transfer was highest in the 0.25 mg group, i.e. 36.8 % per attempt and 40.3 % per transfer, and resulted in an ongoing pregnancy rate 12-16 weeks after embryo transfer of 33.8% per attempt and 37.1% per transfer.
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384923
15HumanNon-randomized trialSafety outcome
In women undergoing ovarian stimulation, ganirelix appeared safe and well tolerated overall.
In plain wordsIn women undergoing ovarian stimulation, ganirelix appeared safe and well tolerated overall.
Peptide
Ganirelix
Outcome
Not applicableTolerability
Study
n = 333
Outcome group
Adverse events · Whole body
Studied dose
0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg once daily · subcutaneous · approximately 5 daysAs given in this study (human).
Source sentences
Summary
Overall, Org 37462 treatment appeared to be safe and well tolerated.
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384913
16HumanNon-randomized trialEfficacy outcome
In women undergoing ovarian stimulation, mean replaced embryo counts ranged from 2.3 to 2.7 across ganirelix dose groups.
In plain wordsIn women undergoing ovarian stimulation, mean transferred embryo counts ranged from 2.3 to 2.7 across ganirelix doses.
Peptide
Ganirelix
Outcome
Not applicableReplaced embryos
Study
n = 333
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg once daily · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Mean replaced embryos
2.3 to 2.7 embryos
across dose groups
Source sentences
Summary
The mean number of replaced embryos in the different dose groups ranged from 2.3 to 2.7.
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384916
17HumanNon-randomized trialEfficacy outcome
In women undergoing ovarian stimulation, LH concentrations at least 10 IU/l occurred in 16% with ganirelix 0.0625 mg.
In plain wordsIn women undergoing ovarian stimulation, high LH occurred in 16% with ganirelix 0.0625 mg.
Peptide
Ganirelix
Outcome
Not applicableLH at least 10 IU/l
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.0625 mg · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Incidence of serum LH >= 10 IU/l
16%
0.0625 mg group, during treatment
Source sentences
Summary
During Org 37462 treatment, serum LH concentrations > or =10 IU/l were observed in the lowest dose groups with incidences of 16% (0.0625 mg), 9% (0.125 mg) and 1.4 % (0.25 mg).
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384905
18HumanNon-randomized trialEfficacy outcome
In women undergoing ovarian stimulation, LH concentrations at least 10 IU/l occurred in 9% with ganirelix 0.125 mg.
In plain wordsIn women undergoing ovarian stimulation, high LH occurred in 9% with ganirelix 0.125 mg.
Peptide
Ganirelix
Outcome
Not applicableLH at least 10 IU/l
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.125 mg · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Incidence of serum LH >= 10 IU/l
9%
0.125 mg group, during treatment
Source sentences
Summary
During Org 37462 treatment, serum LH concentrations > or =10 IU/l were observed in the lowest dose groups with incidences of 16% (0.0625 mg), 9% (0.125 mg) and 1.4 % (0.25 mg).
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384906
19HumanNon-randomized trialEfficacy outcome
In women undergoing ovarian stimulation, LH concentrations at least 10 IU/l occurred in 1.4% with ganirelix 0.25 mg.
In plain wordsIn women undergoing ovarian stimulation, high LH occurred in 1.4% with ganirelix 0.25 mg.
Peptide
Ganirelix
Outcome
Not applicableLH at least 10 IU/l
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.25 mg · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Incidence of serum LH >= 10 IU/l
1.4%
0.25 mg group, during treatment
Source sentences
Summary
During Org 37462 treatment, serum LH concentrations > or =10 IU/l were observed in the lowest dose groups with incidences of 16% (0.0625 mg), 9% (0.125 mg) and 1.4 % (0.25 mg).
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384907
20HumanNon-randomized trialSafety outcome
In women undergoing ovarian stimulation, early miscarriage within the first 6 weeks after embryo transfer was 11.9% with ganirelix 1 mg.
In plain wordsIn women undergoing ovarian stimulation, early miscarriage was 11.9% with ganirelix 1 mg.
Peptide
Ganirelix
Outcome
Not applicableEarly miscarriage
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
1 mg · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Early miscarriage rate
11.9%
1 mg group, first 6 weeks after embryo transfer
Source sentences
Summary
The early miscarriage rates (first 6 weeks after embryo transfer) were 11.9 and 13% in the 1 and 2 mg group respectively, whereas in the other dose groups this incidence was zero (0.0625%) up to a maximum of 3.7% (0.5 mg group).
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384919
21HumanNon-randomized trialSafety outcome
In women undergoing ovarian stimulation, early miscarriage within the first 6 weeks after embryo transfer was 13% with ganirelix 2 mg.
In plain wordsIn women undergoing ovarian stimulation, early miscarriage was 13% with ganirelix 2 mg.
Peptide
Ganirelix
Outcome
Not applicableEarly miscarriage
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
2 mg · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Early miscarriage rate
13%
2 mg group, first 6 weeks after embryo transfer
Source sentences
Summary
The early miscarriage rates (first 6 weeks after embryo transfer) were 11.9 and 13% in the 1 and 2 mg group respectively, whereas in the other dose groups this incidence was zero (0.0625%) up to a maximum of 3.7% (0.5 mg group).
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384920
22HumanNon-randomized trialSafety outcome
In women undergoing ovarian stimulation, early miscarriage ranged from zero in the group labelled 0.0625% to 3.7% with ganirelix 0.5 mg.
In plain wordsIn women undergoing ovarian stimulation, other ganirelix dose groups had early miscarriage rates from zero to 3.7%.
Peptide
Ganirelix
Outcome
Not applicableEarly miscarriage in other doses
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
Dose groups other than 1 mg and 2 mg (includes 0.0625 mg and 0.5 mg) · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Early miscarriage rate
0 to 3.7%
other dose groups, first 6 weeks after embryo transfer
Source sentences
Summary
The early miscarriage rates (first 6 weeks after embryo transfer) were 11.9 and 13% in the 1 and 2 mg group respectively, whereas in the other dose groups this incidence was zero (0.0625%) up to a maximum of 3.7% (0.5 mg group).
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384921
23HumanNon-randomized trialEfficacy outcome
In women undergoing ovarian stimulation, ganirelix 0.25 mg yielded ongoing pregnancy at 12-16 weeks of 33.8% per attempt.
In plain wordsIn women undergoing ovarian stimulation, ongoing pregnancy per attempt was 33.8% with ganirelix 0.25 mg.
Peptide
Ganirelix
Outcome
Not applicableOngoing pregnancy per attempt
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.25 mg · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Ongoing pregnancy rate per attempt
33.8%
0.25 mg group, 12-16 weeks after embryo transfer
Source sentences
Summary
The vital pregnancy rate (with heart activity) at 5-6 weeks after embryo transfer was highest in the 0.25 mg group, i.e. 36.8 % per attempt and 40.3 % per transfer, and resulted in an ongoing pregnancy rate 12-16 weeks after embryo transfer of 33.8% per attempt and 37.1% per transfer.
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384924
24HumanNon-randomized trialEfficacy outcome
In women undergoing ovarian stimulation, ganirelix 0.25 mg yielded ongoing pregnancy at 12-16 weeks of 37.1% per transfer.
In plain wordsIn women undergoing ovarian stimulation, ongoing pregnancy per transfer was 37.1% with ganirelix 0.25 mg.
Peptide
Ganirelix
Outcome
Not applicableOngoing pregnancy per transfer
Study
n: not reported in source
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
0.25 mg · subcutaneous · approximately 5 daysAs given in this study (human).
Measurements
Ongoing pregnancy rate per transfer
37.1%
0.25 mg group, 12-16 weeks after embryo transfer
Source sentences
Summary
The vital pregnancy rate (with heart activity) at 5-6 weeks after embryo transfer was highest in the 0.25 mg group, i.e. 36.8 % per attempt and 40.3 % per transfer, and resulted in an ongoing pregnancy rate 12-16 weeks after embryo transfer of 33.8% per attempt and 37.1% per transfer.
2 context sentences(design, population, supporting numbers)
Summary · context
A multicentre, double-blind, randomized dose-finding study of Org 37462 (ganirelix) was conducted in 333 women undergoing ovarian stimulation with recombinant follicle stimulating hormone (rFSH; Puregon) to establish the minimal effective dose preventing premature luteinizing hormone (LH) surges dur…
Summary · context
From cycle day 7 onward, up to and including the day of human chorionic gonadotrophin (HCG), Org 37462 (dosages 0.0625, 0.125, 0.25, 0.5, 1.0 and 2.0 mg/0.5 ml) was administered once daily by s.c. injection,
Report a problemFND-0985384925

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 4NCT05954962

Efficacy of Micronized Natural Progesterone vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.

Instituto Bernabeun = 15023 Dec 2023 to 30 Aug 2025

IVF

Trial page ClinicalTrials.govUpdated 27 Mar 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:35 UTC
First added · source update from Europe PMC

PepBank is a research reference. Talk to a doctor before you use any peptide.

Summary

Results from this study24

Registered trials1

Efficacy of Micronized Natural Progesterone vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.

Version history

Subjects

Publication types

MeSH terms