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

NCT04414748 | Completed Phase 3

• 1 other identifier: JIAI 2020-05
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preimplantation Genetic Testing; Progestin-primed Ovarian Stimulation; Euploid Rate; GnRH Antagonist

Outcome Measures

Primary Outcomes (1)

• euploidy rate

  euploidy rate of blastocysts

  1 month after oocyte retrieval

Secondary Outcomes (15)

• number of mature oocytes

  1 day after oocyte retrieval

• number and grading of blastocysts

  1 week after oocyte retrieval

• positive serum hCG

  2 weeks after FET

• clinical pregnancy

  6 weeks' gestation

• implantation rate

  6 weeks' gestation

Study Arms (2)

Antagonist group

ACTIVE COMPARATOR

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

PPOS group

EXPERIMENTAL

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

Drug: oral Duphaston

Interventions

GnRH antagonist DRUG

GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of COH till the day of the ovulation trigger

Also known as: Cetrorelix

Antagonist group

oral Duphaston DRUG

oral Duphaston 10mg bd from Day 3 of COH till the day of ovulation trigger.

Also known as: Duphaston

PPOS group

Eligibility Criteria

• Age: 20 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ShangHai Ji Ai Genetics & IVF Institute: lead

Study Sites (1)

Shanghai JiAi Genetics & IVF Institute

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (6)

• 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.

  PMID: 25432917 BACKGROUND

• 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.

  PMID: 30927417 BACKGROUND

• 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.

  PMID: 29300975 BACKGROUND

• 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.

  PMID: 28062551 BACKGROUND

• 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.

  PMID: 25956370 BACKGROUND

• Li H, Yu M, Zhang W, Chen J, Chen H, Lu X, Li L, Ng EHY, Sun X. Comparing blastocyst euploid rates between the progestin-primed and gonadotrophin-releasing hormone antagonist protocols in aneuploidy genetic testing: a randomised trial protocol. BMJ Open. 2024 Mar 23;14(3):e079208. doi: 10.1136/bmjopen-2023-079208.

  PMID: 38521533 DERIVED

MeSH Terms

Interventions

LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-; cetrorelix; Dydrogesterone

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• XIAOXI SUN, PHD

  Shanghai JiAi Genetics & IVF Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 4, 2020
• Study Start: June 10, 2020
• Primary Completion: December 1, 2024
• Study Completion: May 27, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available when beginning 3 months and ending 5 years following article publication.
• 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.

Locations

CN (1)