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

ShangHai Ji Ai Genetics & IVF Institute

Status: Terminated

Conditions: Infertility; ART

Treatments: Drug: Duphaston; Drug: Cetrorelix

Study type: Interventional

Funder types: Other

Identifiers

NCT03680053

JIAI 2018-08

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: Female

Ages: 20 to 43 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

PPOS group

Experimental group

Description:

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.

Treatment:

Drug: Duphaston

Antagonist group

Active Comparator group

Description:

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.

Treatment:

Drug: Cetrorelix