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NCT Number: NCT04414761

Live Birth Rate Between PPOS and GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response

Progestin can inhibit the pituitary LH surge during ovarian stimulation and various studies show progestin-primed ovarian stimulation (PPOS) is effective in blocking the LH surge in IVF. More and more centers in China are using PPOS because this regimen appears simpler and cheaper.A randomized trial to compare the effectiveness of PPOS and GnRH antagonist protocol in IVF in terms of the live birth rate is urgently needed.

Trial objectives: To compare the live birth rate between the PPOS protocol and the antagonist protocol used for ovarian stimulation during IVF

Eligible women will be randomised into one of the two groups:

Antagonist group : Women will receive antagonist (Cetrorelix or Ganirelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.

PPOS group: Women will receive oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger.

There will be no fresh transfer. Only one blastocyst will be allowed to replaced in the first FET and a maximum of two blastocysts will be replaced in the subsequent FET cycles.

The primary outcome is the live birth rate of the first frozen-thawed transfer cycle.

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Key information

Conditions

IVF GnRH Antagonist PPOS

Age range

20 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

ShangHai JIAI Genetics&IVF Institute

Shanghai, 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
  • The first IVF cycle
  • Antral follicle count (AFC) >15 on day 2-5 of the period

Exclusion criteria

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

Treatment and study plan

Progesterone

Drug

oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger

Other names: medroxyprogesterone, duphaston

GnRh antagonist

Drug

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

Other names: Cetrorelix, Ganirelix

Primary outcomes

  1. live birth rate

    Time frame: deliveries ≥22 weeks gestation with heartbeat and breath

    live birth rate of the first frozen embryo transfer cycle

Secondary outcomes

  1. positive serum hCG

    Time frame: 2 weeks after FET

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

  2. clinical pregnancy

    Time frame: 6 weeks' gestation

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

  3. biochemical pregnancy

    Time frame: 6 weeks' gestation

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

  4. implantation rate

    Time frame: 6 weeks' gestation

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

  5. ongoing pregnancy

    Time frame: 12 weeks' gestation

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

  6. cumulative live birth

    Time frame: 2 years' after FET

    cumulative live birth within 6 months of randomization

  7. number of oocytes retrieved

    Time frame: 1 day after oocyte retrieval

    number of oocytes retrieved

  8. number and grading of blastocysts

    Time frame: 1 week after oocyte retrieval

    number and grading of blastocysts suitable for biopsy and freezing

  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. estradiol level on the trigger day

    Time frame: 2 days before oocyte retrieval

  14. progesterone level on the trigger day

    Time frame: 2 days before oocyte retrieval

  15. estradiol and progesterone levels in the follicular fluid

    Time frame: 1 year after FET

    estradiol and progesterone levels in the follicular fluid

  16. 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 Live Birth Rate Between the Progestin-primed Ovarian Stimulation Protocol and the GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response Undergoing IVF

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2020
Registry last updated
Aug 30, 2023

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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