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

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ClinicalTrials.gov Identifier: NCT03680053
Recruitment Status : Not yet recruiting
First Posted : September 21, 2018
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
ShangHai Ji Ai Genetics & IVF Institute

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 multi-centre randomized 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
Infertility ART Drug: Duphaston Drug: Cetrorelix Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 784 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  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 [ 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

  8. 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

  9. 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

  10. 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

  11. multiple pregnancy rate [ Time Frame: multiple pregnancy beyond gestation 12 weeks up to 12 weeks ]
    more than one intrauterine sacs on scanning

  12. miscarriage rate [ Time Frame: 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.

  13. ectopic pregnancy rate [ Time Frame: ectopic pregnancy during first trimester, up to 12 weeks ]
    pregnancy outside the uterine cavity

  14. birth weight [ Time Frame: a live birth after 22 weeks gestation, through study completion, an average of 1 year ]
    birth weight of the baby delivered

  15. rate of participants with adverse events [ Time Frame: adverse events during COH in an average of 1 month ]
    adverse events during COH

  16. rate of obstetric complications [ Time Frame: 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

  17. rate of fetal or congenital defects [ Time Frame: 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



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Ages Eligible for Study:   20 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 > 3

Exclusion Criteria:

  • Presence of a functional ovarian cyst with E2>100 pg/mL
  • Taking any hormonal preparation including oral contraceptive
  • Recipient of oocyte donation
  • Undergoing preimplantation genetic testing
  • Presence of hydrosalpinx which is not surgically treated or endometrial polyp on scanning during ovarian stimulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680053


Contacts
Contact: HE LI, MD +86 13817223099 lihe198900@163.com

Locations
China
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

Publications:

Responsible Party: ShangHai Ji Ai Genetics & IVF Institute
ClinicalTrials.gov Identifier: NCT03680053     History of Changes
Other Study ID Numbers: JIAI 2018-08
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Progestins
Dydrogesterone
Cetrorelix
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Hormone Antagonists