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

ShangHai Ji Ai Genetics & IVF Institute

Status and phase: Begins enrollment in 4 months; Phase 3

Conditions: GnRH Antagonist; Preimplantation Genetic Testing; Progestin-primed Ovarian Stimulation; Polycystic Ovarian Syndrome

Treatments: Drug: GnRH antagonist; Drug: MPA

Study type: Interventional

Funder types: Other

Identifiers

NCT05326087

JIAI 2022-03

Details and patient eligibility

About

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.

Enrollment: 204 estimated patients

Sex: Female

Ages: 20 to 37 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

204 participants in 2 patient groups

Antagonist group

Active Comparator group

Description:

Women will receive antagonist (Cetrotide 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.

Treatment:

Drug: GnRH antagonist

PPOS group

Experimental group

Description:

Women will receive oral MPA 10mg qd from Day 3 till the day of ovulation trigger.

Treatment:

Drug: MPA