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

Not Applicable

Recruiting

• Conditions: ART; Infertility
• Interventions: Drug: Duphaston; Drug: Cetrorelix

• Registration Number: NCT03680053
• Lead Sponsor: ShangHai Ji Ai Genetics & IVF Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-21
• Study Start: 2020-04-10
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-17
• Last Update Posted: 2024-08-20
• Primary Completion: 2024-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 784

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PPOS group	Duphaston	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.
Antagonist group	Cetrorelix	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.

Primary Outcome Measures

Name	Time	Method
live birth rate of the first FET live birth rate of the first FET live birth rate	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

Name	Time	Method
implantation rate	number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks	number of gestational sacs per embryo transferred
positive hCG level	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
ectopic pregnancy rate	ectopic pregnancy during first trimester, up to 12 weeks	pregnancy outside the uterine cavity
Serum FSH level	on the day of hCG trigger, an average of 2 days after randomization	Serum FSH level on Day 2 of the period
Serum LH level	on the day of hCG trigger, an average of 2 weeks after randomization	Serum LH level on the day of hCG trigger
oocyte retrieved number	the number of oocyte retrieved, an average of 2 weeks after randomization
embryo number	the number of embryo, an average of 3 weeks after randomization
rate of obstetric complications	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
Serum estradiol level	on the day of hCG trigger, an average of 2 weeks after randomization	Serum estradiol level on the day of hCG trigger
ongoing pregnancy rate	viable pregnancy beyond gestation 12 weeks, up to 12 weeks	presence of a fetal pole with pulsation at 12 weeks of gestation
Serum progesterone level	on the day of hCG trigger, an average of 2 weeks after randomization	Serum progesterone level on the day of hCG trigger
clinical pregnancy rate	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
miscarriage rate	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.
birth weight	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	adverse events during COH in an average of 1 month	adverse events during COH
multiple pregnancy rate	multiple pregnancy beyond gestation 12 weeks up to 12 weeks	more than one intrauterine sacs on scanning
rate of fetal or congenital defects	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

Trial Locations

Locations (1)

ShangHai JIAI Genetics&IVF Institute; 🇨🇳 Shanghai, China