Current partner codePEPTIDESDE
NCT05326087·Phase 3·INTERVENTIONAL

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

Status

Not yet recruiting

Phase

Phase 3

Enrollment

204

Locations

0

Results

Not posted

Publications

5

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

GnRH antagonist

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

DRUG

MPA

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

Timeline

From registration to results.

  1. First posted

    Apr 13, 2022

  2. Study start

    Jun 1, 2026

  3. Primary completion

    Dec 1, 2027

  4. Study completion

    Dec 1, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Feb 2, 2026

Outcomes

What the study measures.

Primary outcomes

euploidy rate

Time frame · 1 month after oocyte retrieval

euploidy rate of blastocysts

Secondary outcomes

live birth rate

Time frame · 1 year after embryo transfer

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

cumulative live birth rate

Time frame · 1 year after embryo transfer

cumulative live birth within 6 months of randomization

ongoing pregnancy

Time frame · 12 weeks' gestation

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

number of oocytes retrieved

Time frame · 1 day after oocyte retrieval

number of oocytes retrieved

OHSS(ovarian hyperstimulation syndrome)

Time frame · 1 month after ovarian stimulation

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).

birthweight of newborns

Time frame · 1 year after embryo transfer

birthweight of newborns

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
37 Years
Sex
FEMALE
Healthy volunteers
No

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

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

Primary links

Continue at the source.

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