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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04414748
Other study ID # JIAI 2020-05
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04414761 - Live Birth Rate Between PPOS and GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response Phase 3
Recruiting NCT03188471 - Preventive Application of GnRH Antagonist on Early OHSS Phase 4
Recruiting NCT02201914 - Clomiphene Citrate Plus Gonadotropins and GnRH Antagonist Versus Flexible GnRH Antagonist Protocol Versus Microdose GnRH Agonist Protocol in Poor Responders Undergoing IVF Phase 4
Completed NCT01286051 - Single Injection of Ganirelix in Gonadotropin Intrauterine Insemination (IUI) Cycles N/A
Not yet recruiting NCT05326087 - Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Women With PCOS Undergoing PGT-A Phase 3