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AzTrials

Preimplantation Genetic TestingPhase 3NCT04414748

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

A Phase 3 study testing GnRH antagonist and oral Duphaston in people with Preimplantation Genetic Testing and Progestin-primed Ovarian Stimulation, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 43 years, women only
What is being tested?
GnRH antagonist and oral Duphaston
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteChina
Study dates
10 Jun 2020to 27 May 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 43 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai JiAi Genetics & IVF Institute

    Shanghai, Shanghai Municipality, 200011

Other trials in China

About this study

Official 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

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.

Being tested
GnRH antagonist, oral Duphaston

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GnRH antagonistDrug

    Also called Cetrorelix

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

  • oral DuphastonDrug

    Also called Duphaston

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

Study groups in NCT04414748
Study groupRoleWhat they receive
Antagonist groupActive comparatorWomen will receive antagonist (Cetrotide 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
Receives: Drug: GnRH antagonist
PPOS groupExperimentalWomen will receive oral Duphaston 10mg bd from Day 3 till the day of ovulation trigger.
Receives: Drug: oral Duphaston

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. euploidy rate

    euploidy rate of blastocysts

    Measured: 1 month after oocyte retrieval

Secondary outcomes (15)

  1. number of mature oocytes

    number of MII oocytes

    Measured: 1 day after oocyte retrieval

  2. number and grading of blastocysts

    number and grading of blastocysts suitable for biopsy and freezing

    Measured: 1 week after oocyte retrieval

  3. positive serum hCG

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

    Measured: 2 weeks after FET

  4. clinical pregnancy

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

    Measured: 6 weeks' gestation

  5. implantation rate

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

    Measured: 6 weeks' gestation

  6. biochemical pregnancy

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

    Measured: 6 weeks' gestation

  7. ongoing pregnancy

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

    Measured: 12 weeks' gestation

  8. live birth rate

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

    Measured: 1 year after FET

  9. multiple pregnancy

    more than one intrauterine sacs on scanning

    Measured: multiple pregnancy beyond gestation 12 weeks

  10. ectopic pregnancy

    pregnancy outside the uterine cavity

    Measured: ectopic pregnancy during 12 weeks' gestation

  11. birthweight of newborns

    the birth weight of newborns

    Measured: 1 year after FET

  12. serum baseline FSH

    baseline FSH of period day 2-3

    Measured: day 2-3 of period

  13. progesterone level on the trigger day

    progesterone level on the trigger day

    Measured: 2 days before oocyte retrieval

  14. estradiol level on the trigger day

    estradiol level on the trigger day

    Measured: 2 days before oocyte retrieval

  15. miscarriage

    clinically recognised pregnancy loss before 22 weeks of pregnancy.

    Measured: 22 weeks of pregnancy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2020
  2. Study start10 Jun 2020
  3. Primary completion1 Dec 2024
  4. Study completion27 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04414748
Sponsor's protocol ID
JIAI 2020-05
Status last verified
May 2025
First submitted
25 May 2020
Last updated
31 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared.

Publications

  • Lee E, Illingworth P, Wilton L, Chambers GM. The clinical effectiveness of preimplantation genetic diagnosis for aneuploidy in all 24 chromosomes (PGD-A): systematic review. Hum Reprod. 2015 Feb;30(2):473-83. doi: 10.1093/humrep/deu303. Epub 2014 Nov 28.

    PubMed 25432917

  • Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.

    PubMed 30927417

  • Yu S, Long H, Chang HY, Liu Y, Gao H, Zhu J, Quan X, Lyu Q, Kuang Y, Ai A. New application of dydrogesterone as a part of a progestin-primed ovarian stimulation protocol for IVF: a randomized controlled trial including 516 first IVF/ICSI cycles. Hum Reprod. 2018 Feb 1;33(2):229-237. doi: 10.1093/humrep/dex367.

    PubMed 29300975

  • Massin N. New stimulation regimens: endogenous and exogenous progesterone use to block the LH surge during ovarian stimulation for IVF. Hum Reprod Update. 2017 Mar 1;23(2):211-220. doi: 10.1093/humupd/dmw047.

    PubMed 28062551

  • Kuang Y, Chen Q, Fu Y, Wang Y, Hong Q, Lyu Q, Ai A, Shoham Z. Medroxyprogesterone acetate is an effective oral alternative for preventing premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation for in vitro fertilization. Fertil Steril. 2015 Jul;104(1):62-70.e3. doi: 10.1016/j.fertnstert.2015.03.022. Epub 2015 May 5.

    PubMed 25956370

  • Li 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.

    PubMed 42819751

  • Li 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.

    PubMed 38521533

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GnRH antagonist and oral Duphaston in people with Preimplantation Genetic Testing and Progestin-primed Ovarian Stimulation, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

euploidy rate (time frame: 1 month after oocyte retrieval). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04414748, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.

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