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

NCT04414761 | Completed Phase 3

• 1 other identifier: JIAI 2020-06
• Study Type: interventional
• Target: 784
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

IVF; GnRH Antagonist; PPOS

Outcome Measures

Primary Outcomes (1)

• live birth rate

  live birth rate of the first frozen embryo transfer cycle

  deliveries ≥22 weeks gestation with heartbeat and breath

Secondary Outcomes (16)

• positive serum hCG

  2 weeks after FET

• clinical pregnancy

  6 weeks' gestation

• biochemical pregnancy

  6 weeks' gestation

• implantation rate

  6 weeks' gestation

• ongoing pregnancy

  12 weeks' gestation

Study Arms (2)

Antagonist group

ACTIVE COMPARATOR

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.

Drug: GnRH Antagonist

PPOS group

EXPERIMENTAL

Women will receive oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger.

Drug: Progesterone

Interventions

Progesterone DRUG

oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger

Also known as: medroxyprogesterone, duphaston

PPOS group

GnRH Antagonist DRUG

GnRH antagonist (Cetrorelix or Ganirelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger

Also known as: Cetrorelix, Ganirelix

Antagonist group

Eligibility Criteria

• Age: 20 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age of women \<43 years at the time of ovarian stimulation for IVF
• The first IVF cycle
• Antral follicle count (AFC) \>15 on day 2-5 of the period

You may not qualify if:

• Presence of a functional ovarian cyst with E2\>100 pg/mL
• Recipient of oocyte donation
• Undergoing preimplantation genetic testing
• Presence of hydrosalpinx or endometrial polyp which is not surgically treated

Sponsors & Collaborators

• ShangHai Ji Ai Genetics & IVF Institute: lead

Study Sites (1)

ShangHai JIAI Genetics&IVF Institute

Shanghai, China

Location

Related Publications (7)

• Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.

  PMID: 30927417 BACKGROUND

• Yu S, Long H, Chang HY, Liu Y, Gao H, Zhu J, Quan X, Lyu Q, Kuang Y, Ai A. New application of dydrogesterone as a part of a progestin-primed ovarian stimulation protocol for IVF: a randomized controlled trial including 516 first IVF/ICSI cycles. Hum Reprod. 2018 Feb 1;33(2):229-237. doi: 10.1093/humrep/dex367.

  PMID: 29300975 BACKGROUND

• Massin N. New stimulation regimens: endogenous and exogenous progesterone use to block the LH surge during ovarian stimulation for IVF. Hum Reprod Update. 2017 Mar 1;23(2):211-220. doi: 10.1093/humupd/dmw047.

  PMID: 28062551 BACKGROUND

• Kuang Y, Chen Q, Fu Y, Wang Y, Hong Q, Lyu Q, Ai A, Shoham Z. Medroxyprogesterone acetate is an effective oral alternative for preventing premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation for in vitro fertilization. Fertil Steril. 2015 Jul;104(1):62-70.e3. doi: 10.1016/j.fertnstert.2015.03.022. Epub 2015 May 5.

  PMID: 25956370 BACKGROUND

• Dong J, Wang Y, Chai WR, Hong QQ, Wang NL, Sun LH, Long H, Wang L, Tian H, Lyu QF, Lu XF, Chen QJ, Kuang YP. The pregnancy outcome of progestin-primed ovarian stimulation using 4 versus 10 mg of medroxyprogesterone acetate per day in infertile women undergoing in vitro fertilisation: a randomised controlled trial. BJOG. 2017 Jun;124(7):1048-1055. doi: 10.1111/1471-0528.14622.

  PMID: 28276192 BACKGROUND

• Alexandru P, Cekic SG, Yildiz S, Turkgeldi E, Ata B. Progestins versus GnRH analogues for pituitary suppression during ovarian stimulation for assisted reproductive technology: a systematic review and meta-analysis. Reprod Biomed Online. 2020 Jun;40(6):894-903. doi: 10.1016/j.rbmo.2020.01.027. Epub 2020 Feb 5.

  PMID: 32327297 BACKGROUND

• Chen ZQ, Ai A, Zhang Y, Li H, Wang JY, Wang L, Ng EHY. 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. Fertil Steril. 2024 Jun;121(6):937-945. doi: 10.1016/j.fertnstert.2024.01.027. Epub 2024 Jan 23.

  PMID: 38272383 DERIVED

MeSH Terms

Interventions

Progesterone; Medroxyprogesterone; Dydrogesterone; LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-; cetrorelix; ganirelix

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Hydroxyprogesterones; Pregnadienes

Study Officials

• XIAOXI SUN, PHD

  Shanghai JiAi Genetics & IVF Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: June 4, 2020
• Study Start: June 4, 2020
• Primary Completion: October 10, 2022
• Study Completion: October 10, 2022
• Last Updated: August 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available when beginning 3 months and ending 5 years following article publication.
• Access Criteria: To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with. Proposals should be sent to lihe198900@163.com.

Locations

CN (1)