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Trial · Interventional

CompletedPhase 3Registry data

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

NCTNCT04414748 (opens ClinicalTrials.gov in a new tab)Other idJIAI 2020-05
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
400 participants (actual)
Sponsor
ShangHai Ji Ai Genetics & IVF Institute · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
10 Jun 2020
Primary completion
1 Dec 2024
Completion
27 May 2025
First posted
4 Jun 2020
Last update posted
31 May 2025
Conditions
Preimplantation Genetic Testing · Progestin-primed Ovarian Stimulation · Euploid Rate · GnRH Antagonist

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202120222023202420252026
  1. Ph 3

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

    NCT04414748

    10 Jun 2020 to 27 May 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • GnRH antagonistDrug
  • oral DuphastonDrug

Arms2

  • Active comparator

    Antagonist group

    Women will receive antagonist (Cetrotide 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.

  • Experimental

    PPOS group

    Women will receive oral Duphaston 10mg bd from Day 3 till the day of ovulation trigger.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. euploidy rate

    Time frame · 1 month after oocyte retrieval

    Registry description

    euploidy rate of blastocysts

Secondary outcomes(15)

  1. number of mature oocytes

    Time frame · 1 day after oocyte retrieval

    Registry description

    number of MII oocytes

  2. number and grading of blastocysts

    Time frame · 1 week after oocyte retrieval

    Registry description

    number and grading of blastocysts suitable for biopsy and freezing

  3. positive serum hCG

    Time frame · 2 weeks after FET

    Registry description

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

  4. clinical pregnancy

    Time frame · 6 weeks' gestation

    Registry description

    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

    Registry description

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

  6. biochemical pregnancy

    Time frame · 6 weeks' gestation

    Registry description

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

  7. ongoing pregnancy

    Time frame · 12 weeks' gestation

    Registry description

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

  8. live birth rate

    Time frame · 1 year after FET

    Registry description

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

  9. multiple pregnancy

    Time frame · multiple pregnancy beyond gestation 12 weeks

    Registry description

    more than one intrauterine sacs on scanning

  10. ectopic pregnancy

    Time frame · ectopic pregnancy during 12 weeks' gestation

    Registry description

    pregnancy outside the uterine cavity

  11. birthweight of newborns

    Time frame · 1 year after FET

    Registry description

    the birth weight of newborns

  12. serum baseline FSH

    Time frame · day 2-3 of period

    Registry description

    baseline FSH of period day 2-3

  13. progesterone level on the trigger day

    Time frame · 2 days before oocyte retrieval

    Registry description

    progesterone level on the trigger day

  14. estradiol level on the trigger day

    Time frame · 2 days before oocyte retrieval

    Registry description

    estradiol level on the trigger day

  15. miscarriage

    Time frame · 22 weeks of pregnancy

    Registry description

    clinically recognised pregnancy loss before 22 weeks of pregnancy.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2019

9 results

Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial.

Beguería et al. 2019Human reproduction (Oxford, England)cited by 80

PMID 30927417DOI 10.1093/humrep/dez034PUB-30927417

Full text at the publisher9 results
Publisher pageSee results (9)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedLi H, Yu M, Zhang W, Chen J, Chen H, Lu X, Li L, Ng EHY, Sun X. Comparing the euploidy rate between the progestin-primed and gonadotrophin-releasing hormone antagonist protocols in preimplantation genetic testing for aneuploidy: a randomized controlled trial. Hum Reprod Open. 2026 Sep 15;2026(4):hoag081. doi: 10.1093/hropen/hoag081. eCollection 2026. PMID 42819751
  • DerivedLi H, Yu M, Zhang W, Chen J, Chen H, Lu X, Li L, Ng EHY, Sun X. Comparing blastocyst euploid rates between the progestin-primed and gonadotrophin-releasing hormone antagonist protocols in aneuploidy genetic testing: a randomised trial protocol. BMJ Open. 2024 Mar 23;14(3):e079208. doi: 10.1136/bmjopen-2023-079208. PMID 38521533

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 43 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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