Comparison of the Live Birth Rate Between the PPOS and the GnRH Antagonist Protocol in Patients Undergoing IVF
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PPOS group Ovarian stimulation will use the progestin-primed ovarian stimulation (PPOS) protocol.Women will receive progesterone (oral duphaston 20mg) daily from Day 3 till the day of ovulation trigger. |
Drug: Duphaston
Women will receive oral duphaston 20mg daily from Day 3 till the day of ovulation trigger.
|
| Active Comparator: Antagonist group Ovarian stimulation will use the antagonist protocol. Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger. |
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.
|
Outcome Measures
Primary Outcome Measures
- live birth rate of the first FET live birth rate of the first FET live birth rate [a live birth after 22 weeks gestation, through study completion, an average of 1 year]
live birth rate of the first FET
Secondary Outcome Measures
- Serum estradiol level [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 [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 [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 [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 [the number of oocyte retrieved, an average of 2 weeks after randomization]
- embryo number [the number of embryo, an average of 3 weeks after randomization]
- positive hCG level [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 [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 [viable pregnancy beyond gestation 12 weeks, up to 12 weeks]
presence of a fetal pole with pulsation at 12 weeks of gestation
- implantation rate [number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks]
number of gestational sacs per embryo transferred
- multiple pregnancy rate [multiple pregnancy beyond gestation 12 weeks up to 12 weeks]
more than one intrauterine sacs on scanning
- miscarriage rate [a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks]
defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy. The denominator is the clinical pregnancy.
- ectopic pregnancy rate [ectopic pregnancy during first trimester, up to 12 weeks]
pregnancy outside the uterine cavity
- birth weight [a live birth after 22 weeks gestation, through study completion, an average of 1 year]
birth weight of the baby delivered
- rate of participants with adverse events [adverse events during COH in an average of 1 month]
adverse events during COH
- rate of obstetric complications [obstetric complications during pregnancy or delivery in an average of 1 year]
obstetric complications during pregnancy or delivery. The information will be acquired by contacting all the participants through phone
- rate of fetal or congenital defects [fetal or congenital defects found during pregnancy or delivery in an average of 1 year]
fetal or congenital defects found during pregnancy or delivery. The information will be acquired by contacting all the participants through phone
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ShangHai JIAI Genetics&IVF Institute | Shanghai | China |
Sponsors and Collaborators
- ShangHai Ji Ai Genetics & IVF Institute
Investigators
- Principal Investigator: XIAOXI SUN, PHD, Shanghai JiAi Genetics & IVF Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review. Update in: Cochrane Database Syst Rev. 2016;4:CD001750.
- 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.
- 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.
- 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 2018-08