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NCT04414761·Phase 3·INTERVENTIONAL

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

CetrorelixGanirelixOtherCompleted

Status

Completed

Phase

Phase 3

Enrollment

784

Locations

1

Results

Not posted

Publications

7

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Progesterone

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

DRUG

GnRH Antagonist

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

Timeline

From registration to results.

  1. First posted

    Jun 4, 2020

  2. Study start

    Jun 4, 2020

  3. Primary completion

    Oct 10, 2022

  4. Study completion

    Oct 10, 2022

  5. Results posted

    Not reported

  6. Registry updated

    Aug 30, 2023

Outcomes

What the study measures.

Primary outcomes

live birth rate

Time frame · deliveries ≥22 weeks gestation with heartbeat and breath

live birth rate of the first frozen embryo transfer cycle

Secondary outcomes

positive serum hCG

Time frame · 2 weeks after FET

serum β-hCG ≥10 mIU/mL of the first FET

clinical pregnancy

Time frame · 6 weeks' gestation

presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks of the first FET

biochemical pregnancy

Time frame · 6 weeks' gestation

positive serum hCG not followed by clinical pregnancy of the first FET

implantation rate

Time frame · 6 weeks' gestation

the number of gestational sacs per blastocyst transferred of the first FET

ongoing pregnancy

Time frame · 12 weeks' gestation

a viable pregnancy beyond 12 weeks' gestation of the first FET

cumulative live birth

Time frame · 2 years' after FET

cumulative live birth within 6 months of randomization

number of oocytes retrieved

Time frame · 1 day after oocyte retrieval

number of oocytes retrieved

number and grading of blastocysts

Time frame · 1 week after oocyte retrieval

number and grading of blastocysts suitable for biopsy and freezing

multiple pregnancy

Time frame · multiple pregnancy beyond gestation 12 weeks

more than one intrauterine sacs on scanning

ectopic pregnancy

Time frame · ectopic pregnancy during 12 weeks gestation

pregnancy outside the uterine cavity

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
43 Years
Sex
FEMALE
Healthy volunteers
No

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

ShangHai JIAI Genetics&IVF Institute

Shanghai, China

Publications

Results and literature.

PMID 30927417 ↗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 29300975 ↗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 28062551 ↗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 25956370 ↗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 28276192 ↗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 32327297 ↗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 38272383 ↗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.

Primary links

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ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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TrialsCetrorelix trial dashboard →DatabaseCetrorelix database entry →ResearchCetrorelix research guide →TrialsGanirelix trial dashboard →DatabaseGanirelix database entry →ResearchGanirelix research guide →