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

GnRH Antagonist Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04414748
• Other study ID #: JIAI 2020-05
• Status: Recruiting
• Phase: Phase 3
• Start date: June 10, 2020
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: ShangHai Ji Ai Genetics & IVF Institute
• Contact: HE LI, MD
• Phone: +8613817223099
• Email: lihe198900[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• GnRH antagonist
GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of COH till the day of the ovulation trigger
• oral Duphaston
oral Duphaston 10mg bd from Day 3 of COH till the day of ovulation trigger.

Locations

Country	Name	City	State
China	Shanghai JiAi Genetics & IVF Institute	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
ShangHai Ji Ai Genetics & IVF Institute

Country where clinical trial is conducted

China, 

References & Publications (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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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