Comparison of the Live Birth Rate Between the PPOS and the GnRH Antagonist Protocol in Patients Undergoing IVF

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• Infertility 2,506

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 220 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Lead sponsor

ShangHai Ji Ai Genetics & IVF Institute is the lead sponsor of 24 studies on the registry; 6 are open to participants now.

Study arms

• 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

• 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

Interventions

• DrugDuphaston

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

• DrugCetrorelix

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

Primary outcomes

1. live birth rate of the first FET live birth rate of the first FET live birth rate

   live birth rate of the first FET

   Time frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year

Secondary outcomes

1. Serum estradiol level

   Serum estradiol level on the day of hCG trigger

   Time frame: on the day of hCG trigger, an average of 2 weeks after randomization

2. Serum progesterone level

   Serum progesterone level on the day of hCG trigger

   Time frame: on the day of hCG trigger, an average of 2 weeks after randomization

3. Serum LH level

   Serum LH level on the day of hCG trigger

   Time frame: on the day of hCG trigger, an average of 2 weeks after randomization

4. Serum FSH level

   Serum FSH level on Day 2 of the period

   Time frame: on the day of hCG trigger, an average of 2 days after randomization

5. oocyte retrieved number

   Time frame: the number of oocyte retrieved, an average of 2 weeks after randomization

6. embryo number

   Time frame: the number of embryo, an average of 3 weeks after randomization

7. positive hCG level

   defined with the result of serum β-hCG ≥10 mIU/mL

   Time frame: a blood hCG test is performed 14 days after the FET, up to 14 days

8. clinical pregnancy rate

   presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy

   Time frame: presence of intrauterine gestational sac on ultrasound at 6 weeks of pregnancy, up to 6 weeks

9. ongoing pregnancy rate

   presence of a fetal pole with pulsation at 12 weeks of gestation

   Time frame: viable pregnancy beyond gestation 12 weeks, up to 12 weeks

10. implantation rate

    number of gestational sacs per embryo transferred

    Time frame: number of gestational sacs per embryo transferred at 6 weeks of pregnancy, up to 6 weeks

11. multiple pregnancy rate

    more than one intrauterine sacs on scanning

    Time frame: multiple pregnancy beyond gestation 12 weeks up to 12 weeks

12. miscarriage rate

    defined as a clinically recognized pregnancy loss before the 22 weeks of pregnancy. The denominator is the clinical pregnancy.

    Time frame: a clinically recognized pregnancy loss before the 22 weeks of pregnancy, up to 22 weeks

13. ectopic pregnancy rate

    pregnancy outside the uterine cavity

    Time frame: ectopic pregnancy during first trimester, up to 12 weeks

14. birth weight

    birth weight of the baby delivered

    Time frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year

15. rate of participants with adverse events

    adverse events during COH

    Time frame: adverse events during COH in an average of 1 month

16. rate of obstetric complications

    obstetric complications during pregnancy or delivery. The information will be acquired by contacting all the participants through phone

    Time frame: obstetric complications during pregnancy or delivery in an average of 1 year

17. 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

    Time frame: fetal or congenital defects found during pregnancy or delivery in an average of 1 year

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. PubMed 21563131 ↗
• 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. PubMed 25956370 ↗
• 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. PubMed 28276192 ↗
• 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. PubMed 28062551 ↗
• 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. PubMed 29300975 ↗

Individual participant data

Plan to share: Yes — 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).

Supporting information: Study protocol, Sap