Comparison of the Live Birth Rate Between the PPOS and the GnRH Antagonist Protocol in Patients Undergoing IVF

NCT ID: NCT03680053

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-10

Study Completion Date

2025-05-10

Brief Summary

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A randomized comparison of the live birth rate between the progestin-primed ovarian stimulation protocol and the gonadotrophin releasing hormone antagonist protocol in patients undergoing in vitro fertilization

Research question Does the live birth rate of the progestin-primed ovarian stimulation protocol comparable with the GnRH antagonist protocol for patients undergoing IVF?

Design This is a randomized controlled trial.

Research plan

Population: Infertile women who have medical indication for IVF will be recruited for study if they fulfil the selection criteria.

Intervention: Women will receive oral dydrogesterone 20mg daily from Day 3 till the day of ovulation trigger.

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

Outcomes: The primary outcome is the live birth rate the first FET.

Ovarian stimulation, egg retrieval, embryos frozen and frozen embryo transfer will be performed according to the standard operating procedures of the centres.

Detailed Description

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Conditions

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Infertility ART

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PPOS group

Ovarian stimulation will use the progestin-primed ovarian stimulation (PPOS) protocol.Women will receive progesterone (oral duphaston 20mg) daily from Day 3 till the day of ovulation trigger.

Group Type EXPERIMENTAL

Duphaston

Intervention Type DRUG

Women will receive oral duphaston 20mg daily from Day 3 till the day of ovulation trigger.

Antagonist group

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

Group Type ACTIVE_COMPARATOR

Cetrorelix

Intervention Type DRUG

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

Interventions

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Duphaston

Women will receive oral duphaston 20mg daily from Day 3 till the day of ovulation trigger.

Intervention Type DRUG

Cetrorelix

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age of women \<43 years at the time of ovarian stimulation for IVF
* Antral follicle count (AFC) on day 2-5 of the period≥5

Exclusion Criteria

* Presence of a functional ovarian cyst with E2\>100 pg/mL
* Recipient of oocyte donation
* Undergoing preimplantation genetic testing
* Presence of hydrosalpinx which is not surgically treated or endometrial polyp on scanning during ovarian stimulation
Minimum Eligible Age

20 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ShangHai Ji Ai Genetics & IVF Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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XIAOXI SUN, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai JiAi Genetics & IVF Institute

Locations

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ShangHai JIAI Genetics&IVF Institute

Shanghai, , China

Site Status

Countries

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China

References

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Al-Inany HG, Youssef MA, Aboulghar M, Broekmans F, Sterrenburg M, Smit J, Abou-Setta AM. Gonadotrophin-releasing hormone antagonists for assisted reproductive technology. Cochrane Database Syst Rev. 2011 May 11;(5):CD001750. doi: 10.1002/14651858.CD001750.pub3.

Reference Type BACKGROUND
PMID: 21563131 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25956370 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28276192 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28062551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29300975 (View on PubMed)

Other Identifiers

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JIAI 2018-08

Identifier Type: -

Identifier Source: org_study_id

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