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

NCT ID: NCT04414748

Last Updated: 2025-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-10

Study Completion Date

2025-05-27

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

GnRH antagonist

Intervention Type DRUG

GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of COH 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.

Group Type EXPERIMENTAL

oral Duphaston

Intervention Type DRUG

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

Interventions

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GnRH antagonist

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

Intervention Type DRUG

oral Duphaston

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

Intervention Type DRUG

Other Intervention Names

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Cetrorelix Duphaston

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ShangHai Ji Ai Genetics & IVF Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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XIAOXI SUN, PHD

Role: STUDY_DIRECTOR

Shanghai JiAi Genetics & IVF Institute

Locations

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Shanghai JiAi Genetics & IVF Institute

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 25432917 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30927417 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29300975 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28062551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25956370 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38521533 (View on PubMed)

Other Identifiers

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JIAI 2020-05

Identifier Type: -

Identifier Source: org_study_id

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