DRUG
Duphaston
Women will receive oral duphaston 20mg daily from Day 3 till the day of ovulation trigger.
Comparison of the Live Birth Rate Between the PPOS and the GnRH Antagonist Protocol in Patients Undergoing IVF
Status
Terminated
Phase
Not applicable
Enrollment
220
Locations
1
Results
Not posted
Publications
5
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Cetrorelix
Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
Timeline
From registration to results.
First posted
Sep 21, 2018
Study start
Apr 10, 2020
Primary completion
May 10, 2025
Study completion
May 10, 2025
Results posted
Not reported
Registry updated
May 31, 2025
Outcomes
What the study measures.
Primary outcomes
live birth rate of the first FET live birth rate of the first FET live birth rate
Time frame · a live birth after 22 weeks gestation, through study completion, an average of 1 year
live birth rate of the first FET
Secondary outcomes
Serum estradiol level
Time frame · on the day of hCG trigger, an average of 2 weeks after randomization
Serum estradiol level on the day of hCG trigger
Serum progesterone level
Time frame · on the day of hCG trigger, an average of 2 weeks after randomization
Serum progesterone level on the day of hCG trigger
Serum LH level
Time frame · on the day of hCG trigger, an average of 2 weeks after randomization
Serum LH level on the day of hCG trigger
Serum FSH level
Time frame · on the day of hCG trigger, an average of 2 days after randomization
Serum FSH level on Day 2 of the period
oocyte retrieved number
Time frame · the number of oocyte retrieved, an average of 2 weeks after randomization
embryo number
Time frame · the number of embryo, an average of 3 weeks after randomization
positive hCG level
Time frame · a blood hCG test is performed 14 days after the FET, up to 14 days
defined with the result of serum β-hCG ≥10 mIU/mL
clinical pregnancy rate
Time frame · presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks
presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy
ongoing pregnancy rate
Time frame · viable pregnancy beyond gestation 12 weeks, up to 12 weeks
presence of a fetal pole with pulsation at 12 weeks of gestation
implantation rate
Time frame · number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks
number of gestational sacs per embryo transferred
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) 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
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
ShangHai JIAI Genetics&IVF Institute
Shanghai, China
Publications
Results and literature.
PMID 21563131 ↗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.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 28276192 ↗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.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 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.
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