Clinical trial NCT04414748: Comparison of the Euploid Rate of Blastocyst Between PPOS and GnRH Antagonist Protocol in Patients Undergoing PGT-A
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Preimplantation Genetic Testing
Progestin-primed Ovarian Stimulation
Euploid Rate
GnRH Antagonist
Lead sponsor: ShangHai Ji Ai Genetics & IVF Institute
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 400
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: euploidy rate
timeFrame: 1 month after oocyte retrieval
Secondary outcomes:
measure: number of mature oocytes
timeFrame: 1 day after oocyte retrieval
measure: number and grading of blastocysts
timeFrame: 1 week after oocyte retrieval
measure: positive serum hCG
timeFrame: 2 weeks after FET
measure: clinical pregnancy
timeFrame: 6 weeks' gestation
measure: implantation rate
timeFrame: 6 weeks' gestation
measure: biochemical pregnancy
timeFrame: 6 weeks' gestation
measure: ongoing pregnancy
timeFrame: 12 weeks' gestation
measure: live birth rate
timeFrame: 1 year after FET
measure: multiple pregnancy
timeFrame: multiple pregnancy beyond gestation 12 weeks
measure: ectopic pregnancy
timeFrame: ectopic pregnancy during 12 weeks' gestation
measure: birthweight of newborns
timeFrame: 1 year after FET
measure: serum baseline FSH
timeFrame: day 2-3 of period
measure: progesterone level on the trigger day
timeFrame: 2 days before oocyte retrieval
measure: estradiol level on the trigger day
timeFrame: 2 days before oocyte retrieval
measure: miscarriage
timeFrame: 22 weeks of pregnancy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai JiAi Genetics & IVF Institute
state: Shanghai
Study officials:
affiliation: Shanghai JiAi Genetics & IVF Institute
name: XIAOXI SUN, PHD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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.
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.