Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT-A

Polycystic Ovarian Syndrome Clinical Trial

Official title:

A Randomized Control Trial to Compare the Euploid Rate of Blastocyst Between the PPOS (Progestin-primed Ovarian Stimulation) Protocol and the Gonadotropin-releasing Hormone (GnRH) Antagonist Protocol in Women With PCOS (Polycystic Ovary Syndrome) Undergoing PGT-A (Preimplantation Genetic Testing for Aneuploidy)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05326087
• Other study ID #: JIAI 2022-03
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 1, 2024
• Est. completion date: December 1, 2026

Study information

• Verified date: February 2024
• Source: ShangHai Ji Ai Genetics & IVF Institute
• Contact: HE LI, MD
• Phone: +8613817223099
• Email: lihe198900[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 204
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 37 Years

Eligibility

Inclusion Criteria:

• Women age between 20 and 37 years.

• 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:

• Presence of a functional ovarian cyst with E2>100 pg/mL

• Endometriosis grade 3 or higher

• Repeated implantation failure (>=4 embryos replaced or >=2 blastocysts replaced without success)

• 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)

• 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;

• Recipient of oocyte donation

• Presence of hydrosalpinx which is not surgically treated

Related Conditions & MeSH terms

• GnRH Antagonist
• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Preimplantation Genetic Testing
• Progestin-primed Ovarian Stimulation
• Syndrome

Intervention

Drug:
• GnRH antagonist
GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger
• MPA
oral MPA 10mg qd from Day 3 of ovarian stimulation till the day of ovulation trigger.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ShangHai Ji Ai Genetics & IVF Institute

References & Publications (5)

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

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. — 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

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. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	euploidy rate	euploidy rate of blastocysts	1 month after oocyte retrieval
Secondary	live birth rate	deliveries =22 weeks gestation with heartbeat and breath of the first frozen embryo transfer	1 year after embryo transfer
Secondary	cumulative live birth rate	cumulative live birth within 6 months of randomization	1 year after embryo transfer
Secondary	ongoing pregnancy	a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer	12 weeks' gestation
Secondary	number of oocytes retrieved	number of oocytes retrieved	1 day after oocyte retrieval
Secondary	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
Secondary	birthweight of newborns	birthweight of newborns	1 year after embryo transfer