Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Patients Undergoing PGT-A
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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. |
Drug: GnRH antagonist
GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of COH till the day of the ovulation trigger
Other Names:
|
| Experimental: PPOS group Women will receive oral Duphaston 10mg bd from Day 3 till the day of ovulation trigger. |
Drug: oral Duphaston
oral Duphaston 10mg bd from Day 3 of COH till the day of ovulation trigger.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- euploidy rate [1 month after oocyte retrieval]
euploidy rate of blastocysts
Secondary Outcome Measures
- number of mature oocytes [1 day after oocyte retrieval]
number of MII oocytes
- number and grading of blastocysts [1 week after oocyte retrieval]
number and grading of blastocysts suitable for biopsy and freezing
- positive serum hCG [2 weeks after FET]
serum β-hCG ≥10 mIU/mL of the first FET
- clinical pregnancy [6 weeks' gestation]
presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks of the first FET
- implantation rate [6 weeks' gestation]
the number of gestational sacs per blastocyst transferred of the first FET
- biochemical pregnancy [6 weeks' gestation]
positive serum hCG not followed by clinical pregnancy of the first FET
- ongoing pregnancy [12 weeks' gestation]
a viable pregnancy beyond 12 weeks' gestation of the first FET
- live birth rate [1 year after FET]
deliveries ≥22 weeks gestation with heartbeat and breath of the first FET
- multiple pregnancy [multiple pregnancy beyond gestation 12 weeks]
more than one intrauterine sacs on scanning
- ectopic pregnancy [ectopic pregnancy during 12 weeks' gestation]
pregnancy outside the uterine cavity
- birthweight of newborns [1 year after FET]
the birth weight of newborns
- serum baseline FSH [day 2-3 of period]
baseline FSH of period day 2-3
- progesterone level on the trigger day [2 days before oocyte retrieval]
progesterone level on the trigger day
- estradiol level on the trigger day [2 days before oocyte retrieval]
estradiol level on the trigger day
- miscarriage [22 weeks of pregnancy]
clinically recognised pregnancy loss before 22 weeks of pregnancy.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai JiAi Genetics & IVF Institute | Shanghai | Shanghai | China | 200011 |
Sponsors and Collaborators
- ShangHai Ji Ai Genetics & IVF Institute
Investigators
- Study Director: XIAOXI SUN, PHD, Shanghai JiAi Genetics & IVF Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- Beguería R, García D, Vassena R, Rodríguez 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.
- 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.
- 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. Review.
- 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. Review.
- 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.
- JIAI 2020-05