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NCT04414761
Live Birth Rate Between PPOS and GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response
Phase 3 trial testing Progesterone in IVF in 784 participants. Completed in 10 October 2022.
10 October 2022
Quick facts
| Lead sponsor | ShangHai Ji Ai Genetics & IVF Institute |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 784 |
| Start date | 4 June 2020 |
| Primary completion | 10 October 2022 |
| Estimated completion | 10 October 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- Progesterone (Progesterone plus HCG) — full drug profile →
- GnRH Antagonist — full drug profile →
Conditions studied
- IVF — all drugs for IVF →
- GnRH Antagonist — all drugs for GnRH Antagonist →
- PPOS — all drugs for PPOS →
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):
-
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 -
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:
- PubMed search for NCT04414761
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Progesterone
Trials testing the same drug.
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- NCT06631547 — Effect of Progesterone Administration on Severely Head Injured Patients · Phase 1 · not yet recruiting
- NCT07162961 — Nintedanib for Improving Reproductive Outcomes in Adenomyosis · Phase 3 · not yet recruiting
- NCT06851754 — Hormone Replacement Therapy in Adolescents With Premature Ovarian Insufficiency · Phase 3 · recruiting
- NCT06928844 — Role of Low Dose Injectable Progesterone in Triggering Ovulation · NA · recruiting
Other recruiting trials for IVF
Currently open trials in the same condition.
- NCT07364526 — Non-Invasive Preimplantation Genetic Screening for Aneuploidies and Clinical Outcomes in Egg Donation Patients · recruiting
- NCT07088640 — Single Step Protocol and Multi-step Warming Protocol for Blastocyst FET · NA · recruiting
- NCT06544837 — Trial to Evaluate the Clinical Utility of Non-invasive Endometrial Receptivity Test (Ora) in Patients With Implantation · NA · recruiting
- NCT06334003 — Cardiometabolic Function in Offspring, Mother and Placenta After Assisted Reproductive Technology · recruiting
- NCT06577181 — Effect of HCG on Endometrial Preparation in Frozen Embryo Transfer · active not recruiting
Other ShangHai Ji Ai Genetics & IVF Institute trials
Trials by the same sponsor.
- NCT05326087 — Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT · Phase 3 · not yet recruiting
- NCT06561451 — Live Birth Rate Between ICSI and AOA and ICSI Alone in Patients With Severe Teratospermia · NA · recruiting
- NCT05739019 — The Impact of Past Coronavirus Disease 19 (COVID-19) Infection on the Live Birth Rates of Frozen Embryo Transfer Cycles · completed
- NCT06722313 — Optimized PGT-M Strategy for Patients With No Proband · NA · enrolling by invitation
- NCT05447208 — Effect of GH on the Blastocyst Euploid Rate in AMA Patients · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04414761 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by ShangHai Ji Ai Genetics & IVF Institute
- Last refreshed: 30 August 2023
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.
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