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This randomized trial aims to compare the euploid rate of blastocysts between PPOS (progestin-primed ovarian stimulation) and GnRH (gonadotrophin releasing hormone) antagonist protocols in patients with PCOS (polycystic ovary syndrome) undergoing PGT-A (preimplantation genetic testing for aneuploidy). Infertile women with PCOS 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 MPA (medroxyprogesterone acetate)10mg qd 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 MPA 10mg qd 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 ovarian stimulation 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 |
|---|---|---|
| live birth rate | deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer | 1 year after embryo transfer |
| cumulative live birth rate | cumulative live birth within 6 months of randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HE LI, MD | Contact | +8613817223099 | lihe198900@163.com | |
| XIAOXI SUN, PHD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| XIAOXI SUN, PHD | Shanghai JiAi Genetics & IVF Institute, China | Principal Investigator |
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| 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. | |
| 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. |
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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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|
| MPA | Drug | oral MPA 10mg qd from Day 3 of ovarian stimulation till the day of ovulation trigger. |
|
| 1 year after embryo transfer |
| ongoing pregnancy | a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer | 12 weeks' gestation |
| number of oocytes retrieved | number of oocytes retrieved | 1 day after oocyte retrieval |
| OHSS(ovarian hyperstimulation syndrome) | Moderate or severe ovarian hyperstimulation syndrome.Ovarian hyperstimulation syndrome (OHSS) is diagnosed and classified according to the Royal College of Obstetricians and Gynaecologists guideline. Green-top guideline No.5. Ovarian hyperstimulation syndrome. https://www.rcog.org.uk/en/guidelines-research-services/guidelines/gtg5/ (accessed 26 Feb 2016). | 1 month after ovarian stimulation |
| birthweight of newborns | birthweight of newborns | 1 year after embryo transfer |
| 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. |
| 16249284 | Background | Ehrmann DA, Liljenquist DR, Kasza K, Azziz R, Legro RS, Ghazzi MN; PCOS/Troglitazone Study Group. Prevalence and predictors of the metabolic syndrome in women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 Jan;91(1):48-53. doi: 10.1210/jc.2005-1329. Epub 2005 Oct 25. |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C092464 | LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)- |
| C062876 | cetrorelix |
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