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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04414761
Other study ID # JIAI 2020-06
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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