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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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ART, Infertility

Intervention / Treatment
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* Drug: Duphaston
* Drug: Cetrorelix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPOS group<br>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<br>* Women will receive oral duphaston 20mg daily from Day 3 till the day of ovulation trigger.<br>|
| Active Comparator: Antagonist group<br>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<br>* Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |