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The study was terminated due to difficulty in recruiting patients.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPOS group | Experimental | 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. |
|
| Antagonist group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duphaston | Drug | Women will receive oral duphaston 20mg daily from Day 3 till the day of ovulation trigger. |
|
| Measure | Description | Time Frame |
|---|---|---|
| live birth rate of the first FET live birth rate of the first FET live birth rate | live birth rate of the first FET | a live birth after 22 weeks gestation, through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Serum estradiol level | Serum estradiol level on the day of hCG trigger | on the day of hCG trigger, an average of 2 weeks after randomization |
| Serum progesterone level | Serum progesterone level on the day of hCG trigger |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| XIAOXI SUN, PHD | Shanghai JiAi Genetics & IVF Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ShangHai JIAI Genetics&IVF Institute | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21563131 | Background | 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. | |
| 25956370 | Background | 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. |
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Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared. Data will be available when beginning 3 months and ending 5 years following article publication. To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with.Data will be made available by the following way. Proposals should be directed to lihe198900@163.com. And data are available for 5 years at a third party website (link to be included after the article publication).
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D004394 | Dydrogesterone |
| C062876 | cetrorelix |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Cetrorelix | Drug | Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger. |
|
| on the day of hCG trigger, an average of 2 weeks after randomization |
| Serum LH level | Serum LH level on the day of hCG trigger | on the day of hCG trigger, an average of 2 weeks after randomization |
| Serum FSH level | Serum FSH level on Day 2 of the period | on the day of hCG trigger, an average of 2 days after randomization |
| 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 | defined with the result of serum β-hCG ≥10 mIU/mL | a blood hCG test is performed 14 days after the FET, up to 14 days |
| clinical pregnancy rate | presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy | presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks |
| ongoing pregnancy rate | presence of a fetal pole with pulsation at 12 weeks of gestation | viable pregnancy beyond gestation 12 weeks, up to 12 weeks |
| implantation rate | number of gestational sacs per embryo transferred | number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks |
| multiple pregnancy rate | more than one intrauterine sacs on scanning | multiple pregnancy beyond gestation 12 weeks up to 12 weeks |
| miscarriage rate | defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy. The denominator is the clinical pregnancy. | a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks |
| ectopic pregnancy rate | pregnancy outside the uterine cavity | ectopic pregnancy during first trimester, up to 12 weeks |
| birth weight | birth weight of the baby delivered | a live birth after 22 weeks gestation, through study completion, an average of 1 year |
| rate of participants with adverse events | adverse events during COH | adverse events during COH in an average of 1 month |
| rate of obstetric complications | obstetric complications during pregnancy or delivery. The information will be acquired by contacting all the participants through phone | obstetric complications during pregnancy or delivery in an average of 1 year |
| rate of fetal or congenital defects | fetal or congenital defects found during pregnancy or delivery. The information will be acquired by contacting all the participants through phone | fetal or congenital defects found during pregnancy or delivery in an average of 1 year |
| 28276192 | Background | 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. |
| 28062551 | Background | 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. |
| 29300975 | Background | 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. |
| D011083 |
| Polycyclic Compounds |