Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Patients Undergoing PGT-A

A Randomized Control Trial to Compare the Euploid Rate of Blastocyst Between the Progestin-primed Ovarian Stimulation Protocol and the GnRH Antagonist Protocol in Patients Undergoing PGT-A

This randomized trial aims to compare the euploid rate of blastocysts between PPOS and GnRH antagonist protocols in patients undergoing PGT-A. Infertile women who have medical indication for PGT-A will be recruited for study after explanation and counseling if they fulfill the inclusion criteria and do not have the exclusion criteria. Eligible women will be randomised into one of the two groups:

Antagonist group: Women will receive antagonist once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.

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

The primary outcome is the euploidy rate of blastocysts.

Study Overview

• Status: Completed
• Conditions: GnRH Antagonist; Preimplantation Genetic Testing; Progestin-primed Ovarian Stimulation; Euploid Rate
• Intervention / Treatment: Drug: GnRH antagonist; Drug: oral Duphaston

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Shanghai JiAi Genetics & IVF Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 43 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age of women <43 years at the time of ovarian stimulation for IVF
• Antral follicle count (AFC) >=5 on day 2-5 of the period
• PGT-A indicated for advanced maternal age (>=38 years), recurrent miscarriage (>=2 consecutive miscarriage) and repeated implantation failure (>=4 embryos replaced or >=2 blastocysts replaced without success), recurrent foetal aneuploidy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Antagonist group; Women will receive antagonist (Cetrotide 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.	Drug: GnRH antagonist; GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of COH till the day of the ovulation trigger; Other Names: Cetrorelix
Experimental: PPOS group; Women will receive oral Duphaston 10mg bd from Day 3 till the day of ovulation trigger.	Drug: oral Duphaston; oral Duphaston 10mg bd from Day 3 of COH till the day of ovulation trigger.; Other Names: Duphaston

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
euploidy rate	euploidy rate of blastocysts	1 month after oocyte retrieval

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: ShangHai Ji Ai Genetics & IVF Institute
• Investigators: Study Director: Xiaoxi Sun, Phd, Shanghai JiAi Genetics & IVF Institute

Publications and helpful links

General Publications

• 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.
• Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.
• 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.
• 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.
• Lee E, Illingworth P, Wilton L, Chambers GM. The clinical effectiveness of preimplantation genetic diagnosis for aneuploidy in all 24 chromosomes (PGD-A): systematic review. Hum Reprod. 2015 Feb;30(2):473-83. doi: 10.1093/humrep/deu303. Epub 2014 Nov 28.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2020
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): May 27, 2025

Study Registration Dates

• First Submitted: May 25, 2020
• First Submitted That Met QC Criteria: May 31, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Reproductive Control Agents; Hormone Antagonists; Fertility Agents, Female; Fertility Agents; Progestins; Dydrogesterone; Cetrorelix
• Other Study ID Numbers: JIAI 2020-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared.
• IPD Sharing Time Frame: Data will be available when beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with. Proposals should be sent to lihe198900@163.com.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No