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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03680053
• Other study ID #: JIAI 2018-08
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2020
• Est. completion date: December 2025

Study information

• Verified date: April 2023
• Source: ShangHai Ji Ai Genetics & IVF Institute
• Contact: HE LI, MD
• Phone: +86 13817223099
• Email: lihe198900[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 784
• Est. completion date: December 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• ART
• Infertility

Intervention

Drug:
• Duphaston
Women will receive oral duphaston 20mg daily from Day 3 till the day of ovulation trigger.
• Cetrorelix
Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.

Locations

Country	Name	City	State
China	ShangHai JIAI Genetics&IVF Institute	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
ShangHai Ji Ai Genetics & IVF Institute

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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