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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age20-37
SponsorShangHai Ji Ai Genetics & IVF Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • GnRH antagonist

    Drug

    GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger

  • MPA

    Drug

    oral MPA 10mg qd from Day 3 of ovarian stimulation till the day of ovulation trigger.

Treatment groups

204 Participants
are divided into 2 treatment groups
Group A: Antagonist groupActive comparator 1 intervention
Group B: PPOS groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

euploidy rate

euploidy rate of blastocysts

Time frame
1 month after oocyte retrieval

Secondary outcomes

1

live birth rate

deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer

Time frame
1 year after embryo transfer
2

cumulative live birth rate

cumulative live birth within 6 months of randomization

Time frame
1 year after embryo transfer
3

ongoing pregnancy

a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer

Time frame
12 weeks' gestation
4

number of oocytes retrieved

number of oocytes retrieved

Time frame
1 day after oocyte retrieval

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: