Last reviewed · How we verify

NCT04414761

Live Birth Rate Between PPOS and GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response

Completed Phase 3 Last updated 30 August 2023
What this trial tests

Phase 3 trial testing Progesterone in IVF in 784 participants. Completed in 10 October 2022.

Timeline
4 June 2020
Primary endpoint
10 October 2022
10 October 2022

Quick facts

Lead sponsorShangHai Ji Ai Genetics & IVF Institute
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment784
Start date4 June 2020
Primary completion10 October 2022
Estimated completion10 October 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

ShangHai Ji Ai Genetics & IVF Institute

Who can join

Adults 20 to 43, female only, with IVF or GnRH Antagonist. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Progestin can inhibit the pituitary LH surge during ovarian stimulation and various studies show progestin-primed ovarian stimulation (PPOS) is effective in blocking the LH surge in IVF. More and more centers in China are using PPOS because this regimen appears simpler and cheaper.A randomized trial to compare the effectiveness of PPOS and GnRH antagonist protocol in IVF in terms of the live birth rate is urgently needed. Trial objectives: To compare the live birth rate between the PPOS protocol and the antagonist protocol used for ovarian stimulation during IVF Eligible women will be randomised into one of the two groups: Antagonist group : Women will receive antagonist (Cetrorelix or Ganirelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger. PPOS group: Women will receive oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger. There will be no fresh transfer. Only one blastocyst will be allowed to replaced in the first FET and a maximum of two blastocysts will be replaced in the subsequent FET cycles. The primary outcome is the live birth rate of the first frozen-thawed transfer cycle.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A randomized controlled trial to compare the live birth rate of the first frozen embryo transfer following the progestin-primed ovarian stimulation protocol vs. the antagonist protocol in women with an anticipated high ovarian response.
    Chen ZQ, Ai A, Zhang Y, Li H, et al · · 2024 · cited 15× · PMID 38272383 · DOI 10.1016/j.fertnstert.2024.01.027
  2. Progestogens for prevention of luteinising hormone (LH) surge in women undergoing controlled ovarian hyperstimulation as part of an assisted reproductive technology (ART) cycle.
    Glujovsky D, Pesce R, Miguens M, Sueldo C, et al · · 2023 · cited 7× · PMID 38032057 · DOI 10.1002/14651858.cd013827.pub2

Verify or expand the search:

Other trials of Progesterone

Trials testing the same drug.

Other recruiting trials for IVF

Currently open trials in the same condition.

Other ShangHai Ji Ai Genetics & IVF Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04414761.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing