Efficacy and safety of newly developed ganirelix acetate in infertile women for assisted reproductive technology: a prospective, randomised, controlled study.

Han EJ, Lyu SW, Kwak IP, Kwon H, Choi DH, Kim JY, Park HM, Kim JW, Chang EM, Lee HJ, Kim MK, Lee HN, Kim JY, Park S, Lee WS

Journal of obstetrics and gynaecology : the journal of the Institute of Obstetrics and Gynaecology7 Mar 2022Cited by 2 (Europe PMC)

PMID35254199DOI10.1080/01443615.2022.2036955PepBankPUB-35254199

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Summary

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

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In infertile women, patients with LH >10 mIU/mL on the day of hCG injection numbered 0 (0.0%) with Ganilever and 3 (2.5%) with Orgalutran (p = .25).
In plain wordsIn infertile women, premature LH surge did not differ significantly between Ganilever and Orgalutran.
Peptide
Ganirelix
Outcome
No significant changePremature LH surge
Study
n = 236
Comparator
Orgalutran ganirelix acetate
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
Dose not stated
Measurements
Patients with LH >10 mIU/mL on hCG day
0 patients
Ganilever group
Patients with LH >10 mIU/mL on hCG day
0%
Ganilever group
Patients with LH >10 mIU/mL on hCG day
3 patients
Orgalutran group
Patients with LH >10 mIU/mL on hCG day
2.5%
Orgalutran group
Source sentences
Summary
The patients with LH of >10 mIU/mL on the day of human chorionic gonadotropin (hCG) injection were 0 (0.0%) and 3 (2.5%) in the Ganilever and Orgalutran groups, respectively (p= .25).
3 context sentences(design, population, supporting numbers)
Summary · context
This study aimed to investigate the efficacy of Ganilever pre-filled syringe (PFS), a newly developed ganirelix acetate, for the inhibition of premature luteinising hormone (LH) surge in in vitro fertilisation (IVF).
Summary · context
A prospective randomised controlled study was conducted (NCT03051087).
Summary · context
A total of 236 women (Ganilever group: 114, Orgalutran group: 122) were finally analysed.
Report a problemFND-3525419901
02HumanRandomized controlled trialEfficacy outcome
In infertile women, the number of retrieved oocytes did not differ significantly between the two groups (12.0 ± 6.4 vs. 11.8 ± 6.3, p = .73).
In plain wordsIn infertile women, egg retrieval numbers did not differ significantly between Ganilever and Orgalutran.
Peptide
Ganirelix
Outcome
No significant changeRetrieved oocytes
Study
n = 236
Comparator
Orgalutran ganirelix acetate
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
Dose not stated
Measurements
Retrieved oocytes, mean
12 oocytes
first value of the reported 'vs.' pair; SD 6.4
Retrieved oocytes, mean
11.8 oocytes
second value of the reported 'vs.' pair; SD 6.3
Source sentences
Summary
The number of retrieved oocytes from two groups did not show any significant difference (12.0 ± 6.4 vs. 11.8 ± 6.3, p= .73).
3 context sentences(design, population, supporting numbers)
Summary · context
This study aimed to investigate the efficacy of Ganilever pre-filled syringe (PFS), a newly developed ganirelix acetate, for the inhibition of premature luteinising hormone (LH) surge in in vitro fertilisation (IVF).
Summary · context
A prospective randomised controlled study was conducted (NCT03051087).
Summary · context
A total of 236 women (Ganilever group: 114, Orgalutran group: 122) were finally analysed.
Report a problemFND-3525419902
03HumanRandomized controlled trialEfficacy outcome
In infertile women, Ganilever and Orgalutran did not differ significantly in good-quality oocytes and embryos or fertilisation rate.
In plain wordsIn infertile women, Ganilever and Orgalutran had similar good-quality egg and embryo numbers and fertilisation rates.
Peptide
Ganirelix
Outcome
No significant changeGood-quality oocytes and embryos and fertilisation
Study
n = 236
Comparator
Orgalutran ganirelix acetate
Outcome group
Sex hormones and fertility · Reproductive and sexual health
Studied dose
Dose not stated
Source sentences
Summary
Furthermore, the two groups did not show significant differences in the number of good-quality oocytes and embryo, and the rate of fertilisation.
3 context sentences(design, population, supporting numbers)
Summary · context
This study aimed to investigate the efficacy of Ganilever pre-filled syringe (PFS), a newly developed ganirelix acetate, for the inhibition of premature luteinising hormone (LH) surge in in vitro fertilisation (IVF).
Summary · context
A prospective randomised controlled study was conducted (NCT03051087).
Summary · context
A total of 236 women (Ganilever group: 114, Orgalutran group: 122) were finally analysed.
Report a problemFND-3525419903
04HumanRandomized controlled trialSafety outcome
In infertile women, Ganilever and Orgalutran had similar safety profiles.
In plain wordsIn infertile women, Ganilever and Orgalutran had similar safety profiles.
Peptide
Ganirelix
Outcome
Direction not reportedSafety profile
Study
n = 236
Comparator
Orgalutran ganirelix acetate
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated
Source sentences
Summary
Similar safety profiles were also observed.
3 context sentences(design, population, supporting numbers)
Summary · context
This study aimed to investigate the efficacy of Ganilever pre-filled syringe (PFS), a newly developed ganirelix acetate, for the inhibition of premature luteinising hormone (LH) surge in in vitro fertilisation (IVF).
Summary · context
A prospective randomised controlled study was conducted (NCT03051087).
Summary · context
A total of 236 women (Ganilever group: 114, Orgalutran group: 122) were finally analysed.
Report a problemFND-3525419904

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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

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