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

IVF Clinical Trial

Official title:

A Randomized Control Trial to Compare the Live Birth Rate Between the Progestin-primed Ovarian Stimulation Protocol and the GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response Undergoing IVF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414761
• Other study ID #: JIAI 2020-06
• Status: Completed
• Phase: Phase 3
• Start date: June 4, 2020
• Est. completion date: October 10, 2022

Study information

• Verified date: March 2023
• Source: ShangHai Ji Ai Genetics & IVF Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 784
• Est. completion date: October 10, 2022
• Est. primary completion date: October 10, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• GnRH Antagonist
• IVF
• PPOS

Intervention

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

Locations

Country	Name	City	State
China	ShangHai JIAI Genetics&IVF Institute	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
ShangHai Ji Ai Genetics & IVF Institute

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live birth rate	live birth rate of the first frozen embryo transfer cycle	deliveries =22 weeks gestation with heartbeat and breath
Secondary	positive serum hCG	serum ß-hCG =10 mIU/mL of the first FET	2 weeks after FET
Secondary	clinical pregnancy	presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks of the first FET	6 weeks' gestation
Secondary	biochemical pregnancy	positive serum hCG not followed by clinical pregnancy of the first FET	6 weeks' gestation
Secondary	implantation rate	the number of gestational sacs per blastocyst transferred of the first FET	6 weeks' gestation
Secondary	ongoing pregnancy	a viable pregnancy beyond 12 weeks' gestation of the first FET	12 weeks' gestation
Secondary	cumulative live birth	cumulative live birth within 6 months of randomization	2 years' after FET
Secondary	number of oocytes retrieved	number of oocytes retrieved	1 day after oocyte retrieval
Secondary	number and grading of blastocysts	number and grading of blastocysts suitable for biopsy and freezing	1 week after oocyte retrieval
Secondary	multiple pregnancy	more than one intrauterine sacs on scanning	multiple pregnancy beyond gestation 12 weeks
Secondary	ectopic pregnancy	pregnancy outside the uterine cavity	ectopic pregnancy during 12 weeks gestation
Secondary	birthweight of newborns	the birth weight of newborns	1 year after FET
Secondary	serum baseline FSH	baseline FSH of period day 2-3	day 2-3 of period
Secondary	estradiol level on the trigger day		2 days before oocyte retrieval
Secondary	progesterone level on the trigger day		2 days before oocyte retrieval
Secondary	estradiol and progesterone levels in the follicular fluid	estradiol and progesterone levels in the follicular fluid	1 year after FET
Secondary	miscarriage	clinically recognised pregnancy loss before 22 weeks of pregnancy.	22 weeks of pregnancy