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

S

ShangHai Ji Ai Genetics & IVF Institute

Status and phase

Begins enrollment in 5 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

Trial contacts and locations

0

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Central trial contact

XIAOXI SUN, PHD; HE LI, MD

Data sourced from clinicaltrials.gov

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