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

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ClinicalTrials.gov Identifier: NCT03680053

Recruitment Status : Recruiting

First Posted : September 21, 2018

Last Update Posted : May 27, 2020

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Sponsor:

Information provided by (Responsible Party):

ShangHai Ji Ai Genetics & IVF Institute

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Infertility ART	Drug: Duphaston Drug: Cetrorelix	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	784 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	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
Actual Study Start Date :	April 30, 2020
Estimated Primary Completion Date :	September 2022
Estimated Study Completion Date :	December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cetrorelix Cetrorelix acetate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Drug: Duphaston Women will receive oral duphaston 20mg daily from Day 3 till the day of ovulation trigger.
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures :

live birth rate of the first FET live birth rate of the first FET live birth rate [ Time Frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year ]
live birth rate of the first FET

Secondary Outcome Measures :

Serum estradiol level [ Time Frame: on the day of hCG trigger, an average of 2 weeks after randomization ]
Serum estradiol level on the day of hCG trigger
Serum progesterone level [ Time Frame: on the day of hCG trigger, an average of 2 weeks after randomization ]
Serum progesterone level on the day of hCG trigger
Serum LH level [ Time Frame: on the day of hCG trigger, an average of 2 weeks after randomization ]
Serum LH level on the day of hCG trigger
Serum FSH level [ Time Frame: on the day of hCG trigger, an average of 2 days after randomization ]
Serum FSH level on Day 2 of the period
oocyte retrieved number [ Time Frame: the number of oocyte retrieved, an average of 2 weeks after randomization ]
embryo number [ Time Frame: the number of embryo, an average of 3 weeks after randomization ]
positive hCG level [ Time Frame: a blood hCG test is performed 14 days after the FET, up to 14 days ]
defined with the result of serum β-hCG ≥10 mIU/mL
clinical pregnancy rate [ Time Frame: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks ]
presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy
ongoing pregnancy rate [ Time Frame: viable pregnancy beyond gestation 12 weeks, up to 12 weeks ]
presence of a fetal pole with pulsation at 12 weeks of gestation
implantation rate [ Time Frame: number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks ]
number of gestational sacs per embryo transferred
multiple pregnancy rate [ Time Frame: multiple pregnancy beyond gestation 12 weeks up to 12 weeks ]
more than one intrauterine sacs on scanning
miscarriage rate [ Time Frame: a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks ]
defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy. The denominator is the clinical pregnancy.
ectopic pregnancy rate [ Time Frame: ectopic pregnancy during first trimester, up to 12 weeks ]
pregnancy outside the uterine cavity
birth weight [ Time Frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year ]
birth weight of the baby delivered
rate of participants with adverse events [ Time Frame: adverse events during COH in an average of 1 month ]
adverse events during COH
rate of obstetric complications [ Time Frame: obstetric complications during pregnancy or delivery in an average of 1 year ]
obstetric complications during pregnancy or delivery. The information will be acquired by contacting all the participants through phone
rate of fetal or congenital defects [ Time Frame: fetal or congenital defects found during pregnancy or delivery in an average of 1 year ]
fetal or congenital defects found during pregnancy or delivery. The information will be acquired by contacting all the participants through phone

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 43 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680053

Contacts

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Contact: HE LI, MD	+86 13817223099	lihe198900@163.com

Locations

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China
ShangHai JIAI Genetics&IVF Institute	Recruiting
Shanghai, China
Contact: LI HE, MD +8613817223099

Sponsors and Collaborators

ShangHai Ji Ai Genetics & IVF Institute

Investigators

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Principal Investigator:	XIAOXI SUN, PHD	Shanghai JiAi Genetics & IVF Institute

More Information

Publications:

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. Review. Update in: Cochrane Database Syst Rev. 2016;4:CD001750.

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.

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.

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. Review.

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.

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Responsible Party:	ShangHai Ji Ai Genetics & IVF Institute
ClinicalTrials.gov Identifier:	NCT03680053
Other Study ID Numbers:	JIAI 2018-08
First Posted:	September 21, 2018 Key Record Dates
Last Update Posted:	May 27, 2020
Last Verified:	March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared. Data will be available when beginning 3 months and ending 5 years following article publication. To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with.Data will be made available by the following way. Proposals should be directed to lihe198900@163.com. And data are available for 5 years at a third party website (link to be included after the article publication).
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Infertility Cetrorelix Dydrogesterone Fertility Agents, Female Fertility Agents Reproductive Control Agents	Physiological Effects of Drugs Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Progestins Hormones

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