Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT-A
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Antagonist group Women will receive antagonist (Cetrotide 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger. |
Drug: GnRH antagonist
GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger
Other Names:
|
| Experimental: PPOS group Women will receive oral MPA 10mg qd from Day 3 till the day of ovulation trigger. |
Drug: MPA
oral MPA 10mg qd from Day 3 of ovarian stimulation till the day of ovulation trigger.
|
Outcome Measures
Primary Outcome Measures
- euploidy rate [1 month after oocyte retrieval]
euploidy rate of blastocysts
Secondary Outcome Measures
- live birth rate [1 year after embryo transfer]
deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer
- cumulative live birth rate [1 year after embryo transfer]
cumulative live birth within 6 months of randomization
- ongoing pregnancy [12 weeks' gestation]
a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer
- number of oocytes retrieved [1 day after oocyte retrieval]
number of oocytes retrieved
- OHSS（ovarian hyperstimulation syndrome） [1 month after ovarian stimulation]
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).
- birthweight of newborns [1 year after embryo transfer]
birthweight of newborns
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Women age between 20 and 37 years.
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Women diagnosed with PCOS according to the modified Rotterdam criteria: oligomenorrhea or amenorrhea, together with the presence of ≥12 antral follicles (≤9 mm) and/or ovarian volume >10 mL on transvaginal ultrasonographic scanning, and/or clinical/ biochemical hyperandrogenism. Other causes of hyperandrogenism and ovulation dysfunction-including tumours, congenital adrenal hyperplasia, hyperprolactinaemia and thyroid dysfunction-were excluded
Exclusion Criteria:
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Presence of a functional ovarian cyst with E2>100 pg/mL
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Endometriosis grade 3 or higher
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Repeated implantation failure (>=4 embryos replaced or >=2 blastocysts replaced without success)
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Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex); untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s)
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Women who are indicated and planned to undergo PGT-SR (Preimplantation genetic testing for structural rearrangement) or PGT-M (Preimplantation genetic testing for monogenic disorder), for example, parental abnormal karyo-type or diagnosed with monogenic disease;
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Recipient of oocyte donation
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Presence of hydrosalpinx which is not surgically treated
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- ShangHai Ji Ai Genetics & IVF Institute
Investigators
- Principal Investigator: XIAOXI SUN, PHD, Shanghai JiAi Genetics & IVF Institute, China
Study Documents (Full-Text)
None provided.More Information
Publications
- Beguería R, García D, Vassena R, Rodríguez 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.
- 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. Epub 2005 Oct 25.
- 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.
- 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. Review.
- 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. Review.
- JIAI 2022-03