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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Progesterone | Drug | oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger |
|
| Measure | Description | Time Frame |
|---|---|---|
| live birth rate | live birth rate of the first frozen embryo transfer cycle | deliveries ≥22 weeks gestation with heartbeat and breath |
| Measure | Description | Time Frame |
|---|---|---|
| positive serum hCG | serum β-hCG ≥10 mIU/mL of the first FET | 2 weeks after FET |
| clinical pregnancy | presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks of the first FET |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| XIAOXI SUN, PHD | Shanghai JiAi Genetics & IVF Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ShangHai JIAI Genetics&IVF Institute | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30927417 | Background | 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. | |
| 29300975 | 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. |
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Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared.
Data will be available when beginning 3 months and ending 5 years following article publication.
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.
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| ID | Term |
|---|---|
| D011374 | Progesterone |
| D008525 | Medroxyprogesterone |
| D004394 | Dydrogesterone |
| C092464 | LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)- |
| C062876 | cetrorelix |
| C061018 | ganirelix |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| 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 |
|
|
| 6 weeks' gestation |
| biochemical pregnancy | positive serum hCG not followed by clinical pregnancy of the first FET | 6 weeks' gestation |
| implantation rate | the number of gestational sacs per blastocyst transferred of the first FET | 6 weeks' gestation |
| ongoing pregnancy | a viable pregnancy beyond 12 weeks' gestation of the first FET | 12 weeks' gestation |
| cumulative live birth | cumulative live birth within 6 months of randomization | 2 years' after FET |
| number of oocytes retrieved | number of oocytes retrieved | 1 day after oocyte retrieval |
| number and grading of blastocysts | number and grading of blastocysts suitable for biopsy and freezing | 1 week after oocyte retrieval |
| multiple pregnancy | more than one intrauterine sacs on scanning | multiple pregnancy beyond gestation 12 weeks |
| ectopic pregnancy | pregnancy outside the uterine cavity | ectopic pregnancy during 12 weeks gestation |
| birthweight of newborns | the birth weight of newborns | 1 year after FET |
| serum baseline FSH | baseline FSH of period day 2-3 | day 2-3 of period |
| estradiol level on the trigger day | 2 days before oocyte retrieval |
| progesterone level on the trigger day | 2 days before oocyte retrieval |
| estradiol and progesterone levels in the follicular fluid | estradiol and progesterone levels in the follicular fluid | 1 year after FET |
| miscarriage | clinically recognised pregnancy loss before 22 weeks of pregnancy. | 22 weeks of pregnancy |
| 28062551 | 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. |
| 25956370 | 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. |
| 28276192 | 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. |
| 32327297 | 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. |
| 38272383 | Derived | 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. |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D006908 | Hydroxyprogesterones |
| D011245 | Pregnadienes |