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This randomized trial aims to compare the euploid rate of blastocysts between PPOS and GnRH antagonist protocols in patients undergoing PGT-A. Infertile women who have medical indication for PGT-A will be recruited for study after explanation and counseling if they fulfill the inclusion criteria and do not have the exclusion criteria. Eligible women will be randomised into one of the two groups:
Antagonist group: Women will receive antagonist once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
PPOS group: Women will receive oral Duphaston 10mg bd from Day 3 till the day of ovulation trigger.
The primary outcome is the euploidy rate of blastocysts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antagonist group | Active Comparator | Women will receive antagonist (Cetrotide 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 Duphaston 10mg bd from Day 3 till the day of ovulation trigger. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRH antagonist | Drug | GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of COH till the day of the ovulation trigger |
|
| Measure | Description | Time Frame |
|---|---|---|
| euploidy rate | euploidy rate of blastocysts | 1 month after oocyte retrieval |
| Measure | Description | Time Frame |
|---|---|---|
| number of mature oocytes | number of MII oocytes | 1 day after oocyte retrieval |
| number and grading of blastocysts | number and grading of blastocysts suitable for biopsy and freezing |
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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 | Shanghai Municipality | 200011 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25432917 | Background | Lee E, Illingworth P, Wilton L, Chambers GM. The clinical effectiveness of preimplantation genetic diagnosis for aneuploidy in all 24 chromosomes (PGD-A): systematic review. Hum Reprod. 2015 Feb;30(2):473-83. doi: 10.1093/humrep/deu303. Epub 2014 Nov 28. | |
| 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. |
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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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| oral Duphaston | Drug | oral Duphaston 10mg bd from Day 3 of COH till the day of ovulation trigger. |
|
|
| 1 week after oocyte retrieval |
| 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 | 6 weeks' gestation |
| implantation rate | the number of gestational sacs per blastocyst transferred of the first FET | 6 weeks' gestation |
| biochemical pregnancy | positive serum hCG not followed by clinical pregnancy of the first FET | 6 weeks' gestation |
| ongoing pregnancy | a viable pregnancy beyond 12 weeks' gestation of the first FET | 12 weeks' gestation |
| live birth rate | deliveries ≥22 weeks gestation with heartbeat and breath of the first FET | 1 year after FET |
| 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 |
| progesterone level on the trigger day | progesterone level on the trigger day | 2 days before oocyte retrieval |
| estradiol level on the trigger day | estradiol level on the trigger day | 2 days before oocyte retrieval |
| miscarriage | clinically recognised pregnancy loss before 22 weeks of pregnancy. | 22 weeks of pregnancy |
| 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. |
| 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. |
| 38521533 | Derived | Li H, Yu M, Zhang W, Chen J, Chen H, Lu X, Li L, Ng EHY, Sun X. Comparing blastocyst euploid rates between the progestin-primed and gonadotrophin-releasing hormone antagonist protocols in aneuploidy genetic testing: a randomised trial protocol. BMJ Open. 2024 Mar 23;14(3):e079208. doi: 10.1136/bmjopen-2023-079208. |
| ID | Term |
|---|---|
| C092464 | LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)- |
| C062876 | cetrorelix |
| D004394 | Dydrogesterone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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