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

BMC Pregnancy Childbirth. 2021 May 2;21(1):348. doi: 10.1186/s12884-021-03833-2.

Abstract

Background: No 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.

Methods: A 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 registration: NCT02635607 posted on December 16, 2015 in clinicaltrials.gov.

Keywords: Fixed protocol; Flexible protocol; Gonadotropin-releasing hormone antagonists; In vitro fertilization; Number of oocytes retrieved.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Chorionic Gonadotropin / administration & dosage
  • Female
  • Fertilization in Vitro / methods
  • Follicle Stimulating Hormone, Human / administration & dosage
  • Gonadotropin-Releasing Hormone / administration & dosage
  • Gonadotropin-Releasing Hormone / analogs & derivatives
  • Humans
  • Infertility, Female / physiopathology
  • Infertility, Female / therapy*
  • Ovary / drug effects*
  • Ovary / metabolism
  • Ovary / physiopathology
  • Ovulation Induction / methods*
  • Polycystic Ovary Syndrome / complications
  • Polycystic Ovary Syndrome / physiopathology*
  • Pregnancy
  • Pregnancy Rate
  • Recombinant Proteins / administration & dosage
  • Treatment Outcome
  • Triptorelin Pamoate / administration & dosage
  • Young Adult

Substances

  • Chorionic Gonadotropin
  • Follicle Stimulating Hormone, Human
  • Recombinant Proteins
  • follitropin beta
  • Triptorelin Pamoate
  • Gonadotropin-Releasing Hormone
  • ganirelix

Associated data

  • ClinicalTrials.gov/NCT02635607