DRUG
GnRH antagonist
GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of COH till the day of the ovulation trigger
Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Patients Undergoing PGT-A
Status
Completed
Phase
Phase 3
Enrollment
400
Locations
1
Results
Not posted
Publications
6
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
oral Duphaston
oral Duphaston 10mg bd from Day 3 of COH till the day of ovulation trigger.
Timeline
From registration to results.
First posted
Jun 4, 2020
Study start
Jun 10, 2020
Primary completion
Dec 1, 2024
Study completion
May 27, 2025
Results posted
Not reported
Registry updated
May 31, 2025
Outcomes
What the study measures.
Primary outcomes
euploidy rate
Time frame · 1 month after oocyte retrieval
euploidy rate of blastocysts
Secondary outcomes
number of mature oocytes
Time frame · 1 day after oocyte retrieval
number of MII oocytes
number and grading of blastocysts
Time frame · 1 week after oocyte retrieval
number and grading of blastocysts suitable for biopsy and freezing
positive serum hCG
Time frame · 2 weeks after FET
serum β-hCG ≥10 mIU/mL of the first FET
clinical pregnancy
Time frame · 6 weeks' gestation
presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks of the first FET
implantation rate
Time frame · 6 weeks' gestation
the number of gestational sacs per blastocyst transferred of the first FET
biochemical pregnancy
Time frame · 6 weeks' gestation
positive serum hCG not followed by clinical pregnancy of the first FET
ongoing pregnancy
Time frame · 12 weeks' gestation
a viable pregnancy beyond 12 weeks' gestation of the first FET
live birth rate
Time frame · 1 year after FET
deliveries ≥22 weeks gestation with heartbeat and breath of the first FET
multiple pregnancy
Time frame · multiple pregnancy beyond gestation 12 weeks
more than one intrauterine sacs on scanning
ectopic pregnancy
Time frame · ectopic pregnancy during 12 weeks' gestation
pregnancy outside the uterine cavity
Eligibility
Who can take part.
- Minimum age
- 20 Years
- Maximum age
- 43 Years
- Sex
- FEMALE
- Healthy volunteers
- No
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 locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Shanghai JiAi Genetics & IVF Institute
Shanghai, Shanghai Municipality, China
Publications
Results and literature.
PMID 25432917 ↗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 30927417 ↗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 29300975 ↗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 28062551 ↗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 25956370 ↗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 38521533 ↗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.
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