Trial · Interventional

CompletedPhase 3Results postedRegistry data

A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)

NCTNCT00696800Other idP05787Other id2004-004771-11Other id38819Other id8962-011

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 1,509 participants (actual)
Sponsor: Organon and Co · Industry
Design: Randomized · Double masking
Countries: Not stated
Start: 27 Jun 2006
Primary completion: 19 Nov 2007
Completion: 15 Jan 2008
First posted: 13 Jun 2008 (estimated)
Last update posted: 20 Jun 2024
Conditions: In Vitro Fertilization

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2006200720082009

Ph 3
A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)
NCT00696800
27 Jun 2006 to 15 Jan 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa (Organon 36286) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH (recFSH) as a reference. The primary hypothesis is that a single injection of Corifollitropin Alfa is non-inferior to daily treatment with recFSH in initiating multifollicular growth.

Interventions

Corifollitropin alfaDrug
RecFSH / Follitropin beta (Days 1 to 7)Biological
Placebo Corifollitropin alfaDrug
Placebo RecFSH / follitropin betaDrug
RecFSH / Follitropin beta (Days 8 to hCG)Biological
GanirelixDrug
hCGBiological
ProgesteroneBiological

Arms2

Experimental
150 µg Corifollitropin Alfa
Participants received a single subcutaneous (SC) injection of 150 µg Corifollitropin Alfa (org 36286) on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Daily SC injections of Ganirelix were administered from Stimulation Day 5 to the day of hCG; at which time a single dose of hCG was given when 3 follicles \>= 17 mm. On the day of oocyte pick up (OPU) daily doses of progesterone were started and continued for up to 6 weeks or menses.
Active comparator
200 IU recFSH
Participants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG. Daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; at which time a single dose of hCG was administered when 3 follicles \>= 17 mm. On the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.

Primary outcomes2

Outcomes the sponsor listed as primary.

Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)
Time frame · Assessed at least 10 weeks after embryo transfer (up to 1 year)
Registry description
An ongoing pregnancy is a fetus with heart activity at least 10 weeks after embryo transfer as assessed by Ultrasound Scan (USS) or Doppler or is confirmed by live birth. The ongoing pregnancy rate is 100 times the number of participants with an ongoing pregnancy after embryo transfer, divided by the total number of participants who started treatment. Calculations were made per attempt, meaning that participants who did not have embryo transfers were considered not pregnant.
Mean Number of Oocytes Retrieved
Time frame · Up to 36 hours after administration of hCG (up to 1 year)
Registry description
Up to 36 hours after receiving hCG, cumulus-oocyte-complexes were retrieved. Mean numbers retrieved were calculated per attempt, meaning that if a participant did not reach this stage in In Vitro Fertilization (IVF) treatment, zero values were imputed.

Secondary outcomes(20)

Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1
Time frame · From Day 1 to day of hCG treatment (up to 1 year)
Registry description
The amount of recFSH administered for a participant to reach 3 follicles \>= 17 mm, starting from treatment Day 1 onwards.
Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8
Time frame · From Day 8 to Day of hCG treatment (up to 1 year)
Registry description
The amount of recFSH administered for a participant to reach 3 follicles \>= 17 mm, starting from treatment Day 8 onwards.
Serum FSH Levels During Stimulation
Time frame · Up to day of hCG treatment (up to 1 year)
Registry description
Mean serum FSH are presented over one Controlled Ovarian Stimulation (COS) cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.
Serum Luteinizing Hormone (LH) Levels During Stimulation
Time frame · Up to day of hCG treatment (up to 1 year)
Registry description
Mean serum LH levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.
Serum Estradiol (E2) Levels During Stimulation
Time frame · Up to day of hCG treatment (up to 1 year)
Registry description
Mean serum E2 levels are presented over one COS cycle: from Day 1 (Pre-dose) up to the day of hCG treatment.
Serum Progesterone (P) Levels During Stimulation
Time frame · Up to day of hCG treatment (up to 1 year)
Registry description
Mean serum P levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment
Serum Inhibin-B Levels During Stimulation
Time frame · Up to day of hCG treatment (up to 1 year)
Registry description
Mean serum Inhibin-B levels are presented over one COS cycle: from Day 1 (Pre-dose) up to day of hCG treatment
Number of Follicles Categorized by Size on Stimulation Day 1
Time frame · On Day 1 of treatment (up to 1 year)
Registry description
Ovaries were assessed during stimulation by ultrasonographic investigation (USS), and the mean number of follicles are categorized by their size.
Number of Follicles Categorized by Size on Stimulation Day 5
Time frame · On Day 5 of treatment (up to 1 year)
Registry description
Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.
Number of Follicles Categorized by Size on Stimulation Day 8
Time frame · On Day 8 of treatment (up to 1 year)
Registry description
Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.
Number of Follicles Categorized by Size on the Day of hCG
Time frame · Day of HCG treatment (up to 1 year)
Registry description
Ovaries were assessed during stimulation by USS, and the mean number of follicles are categorized by their size.
Number of Cumulus-oocyte-complexes
Time frame · Up to 36 hours after administration of hCG (up to 1 year)
Registry description
Prior to IVF the mean number of cumulus-oocyte-complexes used for IVF was assessed
Number of Oocytes Assessed Prior to Intracytoplasmic Sperm Injection (ICSI)
Time frame · Up to 36 hours after administration of hCG (up to 1 year)
Registry description
The number of oocytes used for ICSI was assessed, and categorized based on their quality
Percentage of Fertilized Oocytes (Fertilization Rate)
Time frame · Up to 18 hours after start of fertilization (up to 1 year)
Registry description
The fertilization rate is 100 times the number of fertilized 2 pro-nuclei (2PN) oocytes obtained, divided by the number of oocytes fertilized by IVF or ICSI
Number of Embryos Obtained on Day 3 Categorized by Quality
Time frame · Post fertilization Day 3 (up to 1 year)
Registry description
Embryos obtained on Day 3 were categorized by their qualiity as follows: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: \< 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 3: fair: 20-50% fragmentation and/or less than 6 cells and/or multinucleation (if observed). Other Grade: Embryos that do not qualify as Grades 1, 2 or 3. Grades 1 and 2 are considered good quality.
Number of Embryos Transferred on Day 3
Time frame · Post fertilization Day 3 (up to 1 year)
Registry description
After fertilization, the mean number of embryos transferred on Day 3 were assessed. Total and good quality embryos are presented, with good quality embryos, Grades 1 and 2, defined as the following: Grade 1: excellent: No fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account. Grade 2: good: \< 20% fragmentation, 6-10 cells, and equal blastomere size taking the impact of cell division into account.
Percentage of Gestational Sacs (Implantation Rate)
Time frame · Up to 6 weeks after embryo transfer (up to 1 year)
Registry description
The implantation rate is 100 times the number of gestational sacs assessed by USS after embryo transfer, divided by the number of embryos transferred.
Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Clinical Pregnancy
Time frame · Up to day of miscarriage (up to 1 year)
Registry description
The miscarriage rate is 100 times the number of miscarriages, divided by the number of clinical pregnancies assessed by USS. A clinical pregnancy is the presence of at least one gestational sac or confirmed by live birth.
Percentage of Participants With a Miscarriage (Miscarriage Rate) Per Vital Pregnancy
Time frame · Up to day of miscarriage (up to 1 year)
Registry description
The miscarriage rate is 100 times the number of miscarriages, divided by the number of vital pregnancies assessed by USS. A vital pregnancy is the presence of at least one fetus with heart activity.
Percentage of Participants With a Biochemical Pregnancy (Pregnancy Rate) Per Attempt
Time frame · Two weeks after embryo transfer (up to 1 year)
Registry description
Biochemical pregnancy was assessed by measuring serum or urinary hCG. Per attempt means that if a participant did not reach the stage of pregnancy assessment zero values were imputed. The pregnancy rate is 100 times the number of participants with pregnancies detected, divided by the number of participants assessed.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· Assessed at least 10 weeks after embryo transfer (up to 1 year)

Percentage of Participants With an Ongoing Pregnancy (Ongoing Pregnancy Rate)

Group	Value (Percentage of participants)
150 µg Corifollitropin Alfa	39.0
200 IU recFSH	38.1

Primary outcomeMean· Up to 36 hours after administration of hCG (up to 1 year)

Mean Number of Oocytes Retrieved

Group	Value (Number of oocytes)	Spread
150 µg Corifollitropin Alfa	13.8	8.3
200 IU recFSH	12.6	6.8

Secondary and other outcome results(6)

Secondary outcomeMedian· From Day 1 to day of hCG treatment (up to 1 year)

Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 1

Group	Value (IU)
150 µg Corifollitropin Alfa	400
200 IU recFSH	1800

Secondary outcomeMedian· From Day 8 to Day of hCG treatment (up to 1 year)

Median Amount of Recombinant FSH Needed to Induce Multifollicular Development Starting at Day 8

Group	Value (IU)
150 µg Corifollitropin Alfa	400
200 IU recFSH	400

Secondary outcomeMean· Up to day of hCG treatment (up to 1 year)

Serum FSH Levels During Stimulation

Group	Value (IU/L)	Spread
150 µg Corifollitropin Alfa	6.70	2.05
200 IU recFSH	6.60	1.86

Secondary outcomeMean· Up to day of hCG treatment (up to 1 year)

Serum Luteinizing Hormone (LH) Levels During Stimulation

Group	Value (IU/L)	Spread
150 µg Corifollitropin Alfa	4.80	2.02
200 IU recFSH	4.67	1.82

Secondary outcomeMean· Up to day of hCG treatment (up to 1 year)

Serum Estradiol (E2) Levels During Stimulation

Group	Value (pmol/L)	Spread
150 µg Corifollitropin Alfa	126.13	39.17
200 IU recFSH	124.79	37.11

Secondary outcomeMean· Up to day of hCG treatment (up to 1 year)

Serum Progesterone (P) Levels During Stimulation

Group	Value (nmol/mL)	Spread
150 µg Corifollitropin Alfa	1.80	1.28
200 IU recFSH	1.85	1.42

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
150 µg Corifollitropin AlfaParticipants received a single SC injection of 150 µg Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections from Stimulation Days 1 to 7 with placebo-recFSH; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; a single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.	–	35 / 755	403 / 755
200 IU recFSHParticipants received a single SC injection of placebo Corifollitropin Alfa on day 2 or 3 of the menstrual cycle (Stimulation Day 1); 7 daily SC injections with 200 IU recFSH from Stimulation Days 1 to 7; followed by daily SC injections with 200 IU recFSH up to the day of hCG; multiple daily SC injections of Ganirelix were given from Stimulation Day 5 to the day of hCG; single dose of hCG was administered when 3 follicles \>= 17 mm were observed; and on the day of OPU daily doses of progesterone were started and continued for up to 6 weeks or menses.	–	30 / 751	383 / 751

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedLawrenz B, Beligotti F, Engelmann N, Gates D, Fatemi HM. Impact of gonadotropin type on progesterone elevation during ovarian stimulation in GnRH antagonist cycles. Hum Reprod. 2016 Nov;31(11):2554-2560. doi: 10.1093/humrep/dew213. Epub 2016 Sep 12. PMID 27619773
DerivedZandvliet AS, Prohn M, de Greef R, van Aarle F, McCrary Sisk C, Stegmann BJ. Impact of patient characteristics on the pharmacokinetics of corifollitropin alfa during controlled ovarian stimulation. Br J Clin Pharmacol. 2016 Jul;82(1):74-82. doi: 10.1111/bcp.12939. Epub 2016 May 31. PMID 26991902
DerivedGriesinger G, Verweij PJ, Gates D, Devroey P, Gordon K, Stegmann BJ, Tarlatzis BC. Prediction of Ovarian Hyperstimulation Syndrome in Patients Treated with Corifollitropin alfa or rFSH in a GnRH Antagonist Protocol. PLoS One. 2016 Mar 7;11(3):e0149615. doi: 10.1371/journal.pone.0149615. eCollection 2016. PMID 26950065
DerivedBroekmans FJ, Verweij PJ, Eijkemans MJ, Mannaerts BM, Witjes H. Prognostic models for high and low ovarian responses in controlled ovarian stimulation using a GnRH antagonist protocol. Hum Reprod. 2014 Aug;29(8):1688-97. doi: 10.1093/humrep/deu090. Epub 2014 Jun 5. PMID 24903202
DerivedLeader A, Devroey P, Witjes H, Gordon K. Corifollitropin alfa or rFSH treatment flexibility options for controlled ovarian stimulation: a post hoc analysis of the Engage trial. Reprod Biol Endocrinol. 2013 Jun 11;11:52. doi: 10.1186/1477-7827-11-52. PMID 23758821
DerivedFauser BC, Alper MM, Ledger W, Schoolcraft WB, Zandvliet A, Mannaerts BM; Engage Investigators. Pharmacokinetics and follicular dynamics of corifollitropin alfa versus recombinant FSH during ovarian stimulation for IVF. Reprod Biomed Online. 2010 Nov;21(5):593-601. doi: 10.1016/j.rbmo.2010.06.032. Epub 2010 Jun 30. PMID 20843746
DerivedDevroey P, Boostanfar R, Koper NP, Mannaerts BM, Ijzerman-Boon PC, Fauser BC; ENGAGE Investigators. A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol. Hum Reprod. 2009 Dec;24(12):3063-72. doi: 10.1093/humrep/dep291. Epub 2009 Aug 14. PMID 19684043

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 36 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Females of couples with an indication for Controlled Ovarian Stimulation (COS) and in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI); * \>=18 and \<=36 years of age at the time of signing informed consent; * Body weight \> 60 and \<=90 kg and body mass index (BMI) \>=18 and \<=32 kg/m\^2; * Normal menstrual cycle length: 24-35 days; * Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed); * Willing and able to sign informed consent. Exclusion Criteria: * History of/or any current (treated) endocrine abnormality; * History of ovarian hyper-response or ovarian hyperstimulation syndrome (OHSS); * History of/or current polycystic ovary syndrome (PCOS); * More than 20 basal antral follicles \<11 mm (both ovaries combined) as measured on ultrasound scan (USS) in the early follicular phase (menstrual cycle day 2-5); * Less than 2 ovaries or any other ovarian abnormality (including endometrioma \> 10 mm; visible on USS); * Presence of unilateral or bilateral hydrosalphinx (visible on USS); * Presence of any clinically relevant pathology affecting the uterine cavity or fibroids \>=5 cm; * More than three unsuccessful IVF cycles since the last established ongoing pregnancy (if applicable); * History of non- or low ovarian response to FSH/ human menopausal gonadotropin (hMG) treatment; * History of recurrent miscarriage (3 or more, even when unexplained); * FSH \> 12 IU/L or LH \> 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5); * Any clinically relevant abnormal laboratory value based on a sample taken during the screening phase; * Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts); * Recent history of/or current epilepsy, human immunodeficiency virus (HIV) infection, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary disease; * Abnormal karyotyping of the patient or her partner (if karyotyping is performed); * Smoking more than 5 cigarettes per day; * History or presence of alcohol or drug abuse within 12 months prior to signing informed consent; * Previous use of Org 36286; * Use of hormonal preparations within 1 month prior to randomization; * Hypersensitivity to any of the concomitant medication prescribed as part of the treatment regimen in this protocol; * Administration of investigational drugs within three months prior to signing informed consent.

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