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Study · Randomized controlled trial · n = 201 · 2021

5 results

Fixed versus flexible antagonist protocol in women with predicted high ovarian response except PCOS: a randomized controlled trial.

Luo X, Pei L, Li F, Li C, Huang G, Ye H

BMC pregnancy and childbirth2 May 2021Cited by 13 (Europe PMC)

PMID33934703 (opens in a new tab)PMCIDPMC8091520 (opens in a new tab)DOI10.1186/s12884-021-03833-2 (opens in a new tab)PepBankPUB-33934703
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Summary

BackgroundNo previous study directly compares the fixed day-5 initiation versus the flexible initiation of GnRH antagonist administration in IVF/ICSI for those patients who are predicted as high ovarian responders without PCOS. To evaluate whether the number of oocytes retrieved is different by using the two GnRH antagonist protocols in Chinese women with predicted high ovarian response except PCOS.MethodsA randomized controlled trial of 201 infertile women with predicted high ovarian response except PCOS undergoing in vitro fertilization. Ovary stimulation was performed using recombinant FSH and GnRH antagonists. GnRH antagonist ganirelix (0.25 mg/d) was started either on day 5 of stimulation (fixed group) or when LH was > 10 IU/L, and/or a follicle with mean diameter > 12 mm was present, and/or serum E2 was > 600 pg/ml. Patient monitoring was initiated on day 3 of stimulation in flexible group.Result(s)No significant difference was observed between the fixed and flexible groups regarding the number of oocytes retrieved (16.72 ± 7.25 vs. 17.47 ± 5.88, P = 0.421), the Gonadotropin treatment duration (9.53 ± 1.07 vs. 9.67 ± 1.03, P = 0.346) and total Gonadotropin dose (1427.75 ± 210.6 vs. 1455.94 ± 243.44, P = 0.381). GnRH antagonist treatment duration in fixed protocol was statistically longer than the flexible protocol (6.57 ± 1.17 vs 6.04 ± 1.03, P = 0.001). There was no premature LH surge in either protocol.Conclusion(s)Fixed GnRH antagonist administration on day 5 of stimulation appear to achieve a comparable oocyte retrieved compared with flexible antagonist administration.Trial registrationNCT02635607 posted on December 16, 2015 in clinicaltrials.gov.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In high ovarian responders without PCOS, fixed ganirelix yielded 16.72 ± 7.25 oocytes versus 17.47 ± 5.88 with flexible initiation (P = 0.421).

    In plain wordsIn women with high ovarian response, egg retrieval numbers were similar with fixed and flexible ganirelix initiation.

    Peptide
    Ganirelix
    Outcome
    No significant changeRetrieved oocytes
    Study

    n = 201

    Comparator
    Flexible ganirelix initiation
    Outcome group
    Sex hormones and fertility · Reproductive and sexual health
    Studied dose
    0.25 mg/dAs given in this study (human).

    Measurements

    Retrieved oocytes, mean
    16.72 oocytes
    fixed group; SD 7.25
    Retrieved oocytes, mean
    17.47 oocytes
    flexible group; SD 5.88

    Source sentences

    Summary
    No significant difference was observed between the fixed and flexible groups regarding the number of oocytes retrieved (16.72 ± 7.25 vs. 17.47 ± 5.88, P = 0.421)
    2 context sentences
    Summary · context
    A randomized controlled trial of 201 infertile women with predicted high ovarian response except PCOS undergoing in vitro fertilization.
    Summary · context
    GnRH antagonist ganirelix (0.25 mg/d) was started either on day 5 of stimulation (fixed group) or when LH was > 10 IU/L, and/or a follicle with mean diameter > 12 mm was present, and/or serum E2 was > 600 pg/ml.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In high ovarian responders without PCOS, gonadotropin duration was 9.53 ± 1.07 with fixed ganirelix versus 9.67 ± 1.03 with flexible initiation (P = 0.346).

    In plain wordsIn women with high ovarian response, gonadotropin duration was similar with fixed and flexible ganirelix initiation.

    Peptide
    Ganirelix
    Outcome
    No significant changeGonadotropin treatment duration
    Study

    n = 201

    Comparator
    Flexible ganirelix initiation
    Outcome group
    Sex hormones and fertility · Reproductive and sexual health
    Studied dose
    0.25 mg/dAs given in this study (human).

    Measurements

    Gonadotropin treatment duration, mean
    9.53 not stated
    fixed group; SD 1.07
    Gonadotropin treatment duration, mean
    9.67 not stated
    flexible group; SD 1.03

    Source sentences

    Summary
    the Gonadotropin treatment duration (9.53 ± 1.07 vs. 9.67 ± 1.03, P = 0.346)
    3 context sentences
    Summary · context
    No significant difference was observed between the fixed and flexible groups regarding
    Summary · context
    A randomized controlled trial of 201 infertile women with predicted high ovarian response except PCOS undergoing in vitro fertilization.
    Summary · context
    GnRH antagonist ganirelix (0.25 mg/d) was started either on day 5 of stimulation (fixed group) or when LH was > 10 IU/L, and/or a follicle with mean diameter > 12 mm was present, and/or serum E2 was > 600 pg/ml.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In high ovarian responders without PCOS, gonadotropin dose was 1427.75 ± 210.6 with fixed ganirelix versus 1455.94 ± 243.44 with flexible initiation (P = 0.381).

    In plain wordsIn women with high ovarian response, gonadotropin dose was similar with fixed and flexible ganirelix initiation.

    Peptide
    Ganirelix
    Outcome
    No significant changeTotal gonadotropin dose
    Study

    n = 201

    Comparator
    Flexible ganirelix initiation
    Outcome group
    Sex hormones and fertility · Reproductive and sexual health
    Studied dose
    0.25 mg/dAs given in this study (human).

    Measurements

    Total gonadotropin dose, mean
    1427.75 not stated
    fixed group; SD 210.6
    Total gonadotropin dose, mean
    1455.94 not stated
    flexible group; SD 243.44

    Source sentences

    Summary
    total Gonadotropin dose (1427.75 ± 210.6 vs. 1455.94 ± 243.44, P = 0.381).
    3 context sentences
    Summary · context
    No significant difference was observed between the fixed and flexible groups regarding
    Summary · context
    A randomized controlled trial of 201 infertile women with predicted high ovarian response except PCOS undergoing in vitro fertilization.
    Summary · context
    GnRH antagonist ganirelix (0.25 mg/d) was started either on day 5 of stimulation (fixed group) or when LH was > 10 IU/L, and/or a follicle with mean diameter > 12 mm was present, and/or serum E2 was > 600 pg/ml.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In high ovarian responders without PCOS, ganirelix duration was longer with fixed than flexible initiation (6.57 ± 1.17 versus 6.04 ± 1.03, P = 0.001).

    In plain wordsIn women with high ovarian response, fixed ganirelix initiation required longer antagonist treatment than flexible initiation.

    Peptide
    Ganirelix
    Outcome
    IncreaseGnRH antagonist treatment duration
    Study

    n = 201

    Comparator
    Flexible ganirelix initiation
    Outcome group
    Sex hormones and fertility · Reproductive and sexual health
    Studied dose
    0.25 mg/dAs given in this study (human).

    Measurements

    GnRH antagonist treatment duration, mean
    6.57 not stated
    fixed protocol; SD 1.17
    GnRH antagonist treatment duration, mean
    6.04 not stated
    flexible protocol; SD 1.03

    Source sentences

    Summary
    GnRH antagonist treatment duration in fixed protocol was statistically longer than the flexible protocol (6.57 ± 1.17 vs 6.04 ± 1.03, P = 0.001).
    2 context sentences
    Summary · context
    A randomized controlled trial of 201 infertile women with predicted high ovarian response except PCOS undergoing in vitro fertilization.
    Summary · context
    GnRH antagonist ganirelix (0.25 mg/d) was started either on day 5 of stimulation (fixed group) or when LH was > 10 IU/L, and/or a follicle with mean diameter > 12 mm was present, and/or serum E2 was > 600 pg/ml.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In high ovarian responders without PCOS, neither fixed nor flexible ganirelix protocols produced premature LH surge.

    In plain wordsIn women with high ovarian response, neither fixed nor flexible ganirelix protocols produced premature LH surge.

    Peptide
    Ganirelix
    Outcome
    No significant changePremature LH surge
    Study

    n = 201

    Comparator
    Flexible ganirelix initiation
    Outcome group
    Sex hormones and fertility · Reproductive and sexual health
    Studied dose
    0.25 mg/dAs given in this study (human).

    Source sentences

    Summary
    There was no premature LH surge in either protocol.
    2 context sentences
    Summary · context
    A randomized controlled trial of 201 infertile women with predicted high ovarian response except PCOS undergoing in vitro fertilization.
    Summary · context
    GnRH antagonist ganirelix (0.25 mg/d) was started either on day 5 of stimulation (fixed group) or when LH was > 10 IU/L, and/or a follicle with mean diameter > 12 mm was present, and/or serum E2 was > 600 pg/ml.

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

Status unknownNot applicableNCT02635607

Effectiveness and Safety Study of Fixed Versus Flexible of Gonadotropin-releasing Hormone Antagonist Protocol

Chong Qing Reproducive and Genetic Instituten = 200Jan 2016 to est. Mar 2017

Infertility

Trial pageClinicalTrials.govUpdated 21 Dec 2015

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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:35 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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