Live Birth Rate Between PPOS and GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response

Phase 3

Completed

• Conditions: IVF; GnRH Antagonist; PPOS
• Interventions: Drug: Progesterone; Drug: GnRH Antagonist

• Registration Number: NCT04414761
• Lead Sponsor: ShangHai Ji Ai Genetics & IVF Institute

Brief Summary

Progestin can inhibit the pituitary LH surge during ovarian stimulation and various studies show progestin-primed ovarian stimulation (PPOS) is effective in blocking the LH surge in IVF. More and more centers in China are using PPOS because this regimen appears simpler and cheaper.A randomized trial to compare the effectiveness of PPOS and GnRH antagonist protocol in IVF in terms of the live birth rate is urgently needed.

Trial objectives: To compare the live birth rate between the PPOS protocol and the antagonist protocol used for ovarian stimulation during IVF

Eligible women will be randomised into one of the two groups:

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

PPOS group: Women will receive oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger.

There will be no fresh transfer. Only one blastocyst will be allowed to replaced in the first FET and a maximum of two blastocysts will be replaced in the subsequent FET cycles.

The primary outcome is the live birth rate of the first frozen-thawed transfer cycle.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-06-02
• Study Start: 2020-06-04
• Study First Posted: 2020-06-04
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

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

Inclusion Criteria

• Age of women <43 years at the time of ovarian stimulation for IVF
• The first IVF cycle
• Antral follicle count (AFC) >15 on day 2-5 of the period

Exclusion Criteria

• Presence of a functional ovarian cyst with E2>100 pg/mL
• Recipient of oocyte donation
• Undergoing preimplantation genetic testing
• Presence of hydrosalpinx or endometrial polyp which is not surgically treated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PPOS group	Progesterone	Women will receive oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger.
Antagonist group	GnRH Antagonist	Women will receive antagonist (Cetrorelix or Ganirelix 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	deliveries ≥22 weeks gestation with heartbeat and breath	live birth rate of the first frozen embryo transfer cycle

Secondary Outcome Measures

Name	Time	Method
progesterone level on the trigger day	2 days before oocyte retrieval
estradiol and progesterone levels in the follicular fluid	1 year after FET	estradiol and progesterone levels in the follicular fluid
implantation rate	6 weeks' gestation	the number of gestational sacs per blastocyst transferred of the first FET
ongoing pregnancy	12 weeks' gestation	a viable pregnancy beyond 12 weeks' gestation of the first FET
cumulative live birth	2 years' after FET	cumulative live birth within 6 months of randomization
number of oocytes retrieved	1 day after oocyte retrieval	number of oocytes retrieved
number and grading of blastocysts	1 week after oocyte retrieval	number and grading of blastocysts suitable for biopsy and freezing
multiple pregnancy	multiple pregnancy beyond gestation 12 weeks	more than one intrauterine sacs on scanning
serum baseline FSH	day 2-3 of period	baseline FSH of period day 2-3
ectopic pregnancy	ectopic pregnancy during 12 weeks gestation	pregnancy outside the uterine cavity
estradiol level on the trigger day	2 days before oocyte retrieval
positive serum hCG	2 weeks after FET	serum β-hCG ≥10 mIU/mL of the first FET
clinical pregnancy	6 weeks' gestation	presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks of the first FET
biochemical pregnancy	6 weeks' gestation	positive serum hCG not followed by clinical pregnancy of the first FET
birthweight of newborns	1 year after FET	the birth weight of newborns
miscarriage	22 weeks of pregnancy	clinically recognised pregnancy loss before 22 weeks of pregnancy.

Trial Locations

Locations (1)

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