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

ShangHai Ji Ai Genetics & IVF Institute

Status and phase: Completed; Phase 3

Conditions: Euploid Rate; GnRH Antagonist; Preimplantation Genetic Testing; Progestin-primed Ovarian Stimulation

Treatments: Drug: oral Duphaston; Drug: GnRH antagonist

Study type: Interventional

Funder types: Other

Identifiers

NCT04414748

JIAI 2020-05

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: Female

Ages: 20 to 43 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age of women <43 years at the time of ovarian stimulation for IVF
• Antral follicle count (AFC) >=5 on day 2-5 of the period
• PGT-A indicated for advanced maternal age (>=38 years), recurrent miscarriage (>=2 consecutive miscarriage) and repeated implantation failure (>=4 embryos replaced or >=2 blastocysts replaced without success), recurrent foetal aneuploidy

Exclusion criteria

• Presence of a functional ovarian cyst with E2>100 pg/mL
• Recipient of oocyte donation
• Presence of hydrosalpinx or endometrial polyp which is not surgically treated

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 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 Duphaston 10mg bd from Day 3 till the day of ovulation trigger.

Treatment:

Drug: oral Duphaston