Infertility, ART
Conditions
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.
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.
Sponsors
ShangHai Ji Ai Genetics & IVF Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 43 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Countries
China
Outcome results
None listed