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Completed

NCT Number: NCT04414748

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

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.

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Key information

Conditions

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

Age range

20 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai JiAi Genetics & IVF Institute

Shanghai, Shanghai Municipality, 200011, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GnRh antagonist

Drug

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

Other names: Cetrorelix

oral Duphaston

Drug

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

Other names: Duphaston

Primary outcomes

  1. euploidy rate

    Time frame: 1 month after oocyte retrieval

    euploidy rate of blastocysts

Secondary outcomes

  1. number of mature oocytes

    Time frame: 1 day after oocyte retrieval

    number of MII oocytes

  2. number and grading of blastocysts

    Time frame: 1 week after oocyte retrieval

    number and grading of blastocysts suitable for biopsy and freezing

  3. positive serum hCG

    Time frame: 2 weeks after FET

    serum β-hCG ≥10 mIU/mL of the first FET

  4. clinical pregnancy

    Time frame: 6 weeks' gestation

    presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks of the first FET

  5. implantation rate

    Time frame: 6 weeks' gestation

    the number of gestational sacs per blastocyst transferred of the first FET

  6. biochemical pregnancy

    Time frame: 6 weeks' gestation

    positive serum hCG not followed by clinical pregnancy of the first FET

  7. ongoing pregnancy

    Time frame: 12 weeks' gestation

    a viable pregnancy beyond 12 weeks' gestation of the first FET

  8. live birth rate

    Time frame: 1 year after FET

    deliveries ≥22 weeks gestation with heartbeat and breath of the first FET

  9. multiple pregnancy

    Time frame: multiple pregnancy beyond gestation 12 weeks

    more than one intrauterine sacs on scanning

  10. ectopic pregnancy

    Time frame: ectopic pregnancy during 12 weeks' gestation

    pregnancy outside the uterine cavity

  11. birthweight of newborns

    Time frame: 1 year after FET

    the birth weight of newborns

  12. serum baseline FSH

    Time frame: day 2-3 of period

    baseline FSH of period day 2-3

  13. progesterone level on the trigger day

    Time frame: 2 days before oocyte retrieval

    progesterone level on the trigger day

  14. estradiol level on the trigger day

    Time frame: 2 days before oocyte retrieval

    estradiol level on the trigger day

  15. miscarriage

    Time frame: 22 weeks of pregnancy

    clinically recognised pregnancy loss before 22 weeks of pregnancy.

Sponsors and collaborators

Lead sponsor

ShangHai Ji Ai Genetics & IVF Institute

Other

Registry information

Official study title

A Randomized Control Trial to Compare the Euploid Rate of Blastocyst Between the Progestin-primed Ovarian Stimulation Protocol and the GnRH Antagonist Protocol in Patients Undergoing PGT-A

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Jun 4, 2020
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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