Clinical trial NCT03680053: Comparison of the Live Birth Rate Between the PPOS and the GnRH Antagonist Protocol in Patients Undergoing IVF
Official title: A Randomized Comparison of the Live Birth Rate Between the Progestin-primed Ovarian Stimulation Protocol and the Gonadotrophin Releasing Hormone Antagonist Protocol in Patients Undergoing in Vitro Fertilization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
ART
Lead sponsor: ShangHai Ji Ai Genetics & IVF Institute
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 220
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: A randomized comparison of the live birth rate between the progestin-primed ovarian stimulation protocol and the gonadotrophin releasing hormone antagonist protocol in patients undergoing in vitro fertilization

Research question Does the live birth rate of the progestin-primed ovarian stimulation protocol comparable with the GnRH antagonist protocol for patients undergoing IVF?

Design This is a randomized controlled trial.

Research plan

Population: Infertile women who have medical indication for IVF will be recruited for study if they fulfil the selection criteria.

Intervention: Women will receive oral dydrogesterone 20mg daily from Day 3 till the day of ovulation trigger.

Comparator: Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.

Outcomes: The primary outcome is the live birth rate the first FET.

Ovarian stimulation, egg retrieval, embryos frozen and frozen embryo transfer will be performed according to the standard operating procedures of the centres.


Eligibility criteria: Inclusion Criteria:

* Age of women \<43 years at the time of ovarian stimulation for IVF
* Antral follicle count (AFC) on day 2-5 of the period≥5

Exclusion Criteria:

* Presence of a functional ovarian cyst with E2\>100 pg/mL
* Recipient of oocyte donation
* Undergoing preimplantation genetic testing
* Presence of hydrosalpinx which is not surgically treated or endometrial polyp on scanning during ovarian stimulation

Primary outcomes:
measure: live birth rate of the first FET live birth rate of the first FET live birth rate
timeFrame: a live birth after 22 weeks gestation, through study completion, an average of 1 year
Secondary outcomes:
measure: Serum estradiol level
timeFrame: on the day of hCG trigger, an average of 2 weeks after randomization
measure: Serum progesterone level
timeFrame: on the day of hCG trigger, an average of 2 weeks after randomization
measure: Serum LH level
timeFrame: on the day of hCG trigger, an average of 2 weeks after randomization
measure: Serum FSH level
timeFrame: on the day of hCG trigger, an average of 2 days after randomization
measure: oocyte retrieved number
timeFrame: the number of oocyte retrieved, an average of 2 weeks after randomization
measure: embryo number
timeFrame: the number of embryo, an average of 3 weeks after randomization
measure: positive hCG level
timeFrame: a blood hCG test is performed 14 days after the FET, up to 14 days
measure: clinical pregnancy rate
timeFrame: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks
measure: ongoing pregnancy rate
timeFrame: viable pregnancy beyond gestation 12 weeks, up to 12 weeks
measure: implantation rate
timeFrame: number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks
measure: multiple pregnancy rate
timeFrame: multiple pregnancy beyond gestation 12 weeks up to 12 weeks
measure: miscarriage rate
timeFrame: a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks
measure: ectopic pregnancy rate
timeFrame: ectopic pregnancy during first trimester, up to 12 weeks
measure: birth weight
timeFrame: a live birth after 22 weeks gestation, through study completion, an average of 1 year
measure: rate of participants with adverse events
timeFrame: adverse events during COH in an average of 1 month
measure: rate of obstetric complications
timeFrame: obstetric complications during pregnancy or delivery in an average of 1 year
measure: rate of fetal or congenital defects
timeFrame: fetal or congenital defects found during pregnancy or delivery in an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: ShangHai JIAI Genetics&IVF Institute
Study officials:
affiliation: Shanghai JiAi Genetics & IVF Institute
name: XIAOXI SUN, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Al-Inany HG, Youssef MA, Aboulghar M, Broekmans F, Sterrenburg M, Smit J, Abou-Setta AM. Gonadotrophin-releasing hormone antagonists for assisted reproductive technology. Cochrane Database Syst Rev. 2011 May 11;(5):CD001750. doi: 10.1002/14651858.CD001750.pub3.
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.
citation: Dong J, Wang Y, Chai WR, Hong QQ, Wang NL, Sun LH, Long H, Wang L, Tian H, Lyu QF, Lu XF, Chen QJ, Kuang YP. The pregnancy outcome of progestin-primed ovarian stimulation using 4 versus 10 mg of medroxyprogesterone acetate per day in infertile women undergoing in vitro fertilisation: a randomised controlled trial. BJOG. 2017 Jun;124(7):1048-1055. doi: 10.1111/1471-0528.14622.
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: 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.