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AzTrials

IVFPhase 3NCT04414761

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

A Phase 3 study testing Progesterone and GnRH Antagonist in people with IVF and GnRH Antagonist, 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

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. Read more about this study

Who is it for?
Ages 20 to 43 years, women only
Conditions the study is for
IVF, GnRH Antagonist, PPOS
What is being tested?
Progesterone and GnRH Antagonist
Could I receive a placebo?
No, everyone receives an active treatment
How many people
784 participants
Where
1 siteChina
Study dates
4 Jun 2020to 10 Oct 2022
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
  • The first IVF cycle
  • Antral follicle count (AFC) >15 on day 2-5 of the period

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • ShangHai JIAI Genetics&IVF Institute

    Shanghai

Other trials in China

About this study

Official 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

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

Read more

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.

Being tested
Progesterone, GnRH Antagonist

What participants receive

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

  • ProgesteroneDrug

    Also called medroxyprogesterone, duphaston

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

  • GnRH AntagonistDrug

    Also called Cetrorelix, Ganirelix

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

Study groups in NCT04414761
Study groupRoleWhat they receive
Antagonist groupActive comparatorWomen will receive antagonist (Cetrorelix or Ganirelix 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 medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger.
Receives: Drug: Progesterone

What is being measured

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

  1. live birth rate

    live birth rate of the first frozen embryo transfer cycle

    Measured: deliveries ≥22 weeks gestation with heartbeat and breath

Secondary outcomes (16)

  1. positive serum hCG

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

    Measured: 2 weeks after FET

  2. clinical pregnancy

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

    Measured: 6 weeks' gestation

  3. biochemical pregnancy

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

    Measured: 6 weeks' gestation

  4. implantation rate

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

    Measured: 6 weeks' gestation

  5. ongoing pregnancy

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

    Measured: 12 weeks' gestation

  6. cumulative live birth

    cumulative live birth within 6 months of randomization

    Measured: 2 years' after FET

  7. number of oocytes retrieved

    number of oocytes retrieved

    Measured: 1 day after oocyte retrieval

  8. number and grading of blastocysts

    number and grading of blastocysts suitable for biopsy and freezing

    Measured: 1 week after oocyte retrieval

  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. estradiol level on the trigger day

    Measured: 2 days before oocyte retrieval

  14. progesterone level on the trigger day

    Measured: 2 days before oocyte retrieval

  15. estradiol and progesterone levels in the follicular fluid

    estradiol and progesterone levels in the follicular fluid

    Measured: 1 year after FET

  16. 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 start4 Jun 2020
  3. Primary completion10 Oct 2022
  4. Study completion10 Oct 2022

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
784 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04414761
Sponsor's protocol ID
JIAI 2020-06
Status last verified
Mar 2023
First submitted
26 May 2020
Last updated
30 Aug 2023
Results posted
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

  • 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

  • Dong J, Wang Y, Chai WR, Hong QQ, Wang NL, Sun LH, Long H, Wang L, Tian H, Lyu QF, Lu XF, Chen QJ, Kuang YP. The pregnancy outcome of progestin-primed ovarian stimulation using 4 versus 10 mg of medroxyprogesterone acetate per day in infertile women undergoing in vitro fertilisation: a randomised controlled trial. BJOG. 2017 Jun;124(7):1048-1055. doi: 10.1111/1471-0528.14622.

    PubMed 28276192

  • Alexandru P, Cekic SG, Yildiz S, Turkgeldi E, Ata B. Progestins versus GnRH analogues for pituitary suppression during ovarian stimulation for assisted reproductive technology: a systematic review and meta-analysis. Reprod Biomed Online. 2020 Jun;40(6):894-903. doi: 10.1016/j.rbmo.2020.01.027. Epub 2020 Feb 5.

    PubMed 32327297

  • Chen ZQ, Ai A, Zhang Y, Li H, Wang JY, Wang L, Ng EHY. A randomized controlled trial to compare the live birth rate of the first frozen embryo transfer following the progestin-primed ovarian stimulation protocol vs. the antagonist protocol in women with an anticipated high ovarian response. Fertil Steril. 2024 Jun;121(6):937-945. doi: 10.1016/j.fertnstert.2024.01.027. Epub 2024 Jan 23.

    PubMed 38272383

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Progesterone and GnRH Antagonist in people with IVF and GnRH Antagonist, 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 4 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 30 Aug 2023. 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?

live birth rate (time frame: deliveries ≥22 weeks gestation with heartbeat and breath). 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 NCT04414761, 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 30 Aug 2023.

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