GnRH Antagonist, IVF, PPOS
Conditions
Brief summary
Progestin can inhibit the pituitary LH surge during ovarian stimulation and various studies show progestin-primed ovarian stimulation (PPOS) is effective in blocking the LH surge in IVF. More and more centers in China are using PPOS because this regimen appears simpler and cheaper.A randomized trial to compare the effectiveness of PPOS and GnRH antagonist protocol in IVF in terms of the live birth rate is urgently needed. Trial objectives: To compare the live birth rate between the PPOS protocol and the antagonist protocol used for ovarian stimulation during IVF Eligible women will be randomised into one of the two groups: Antagonist group : Women will receive antagonist (Cetrorelix or Ganirelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger. PPOS group: Women will receive oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger. There will be no fresh transfer. Only one blastocyst will be allowed to replaced in the first FET and a maximum of two blastocysts will be replaced in the subsequent FET cycles. The primary outcome is the live birth rate of the first frozen-thawed transfer cycle.
Interventions
DRUGProgesterone
oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger
DRUGGnRH Antagonist
GnRH antagonist (Cetrorelix or Ganirelix 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 * The first IVF cycle * Antral follicle count (AFC) \>15 on day 2-5 of the period
Exclusion criteria
* Presence of a functional ovarian cyst with E2\>100 pg/mL * Recipient of oocyte donation * Undergoing preimplantation genetic testing * Presence of hydrosalpinx or endometrial polyp which is not surgically treated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| live birth rate | deliveries ≥22 weeks gestation with heartbeat and breath | live birth rate of the first frozen embryo transfer cycle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical pregnancy | 6 weeks' gestation | presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks of the first FET |
| biochemical pregnancy | 6 weeks' gestation | positive serum hCG not followed by clinical pregnancy of the first FET |
| implantation rate | 6 weeks' gestation | the number of gestational sacs per blastocyst transferred of the first FET |
| ongoing pregnancy | 12 weeks' gestation | a viable pregnancy beyond 12 weeks' gestation of the first FET |
| cumulative live birth | 2 years' after FET | cumulative live birth within 6 months of randomization |
| number of oocytes retrieved | 1 day after oocyte retrieval | number of oocytes retrieved |
| number and grading of blastocysts | 1 week after oocyte retrieval | number and grading of blastocysts suitable for biopsy and freezing |
| positive serum hCG | 2 weeks after FET | serum β-hCG ≥10 mIU/mL of the first FET |
| ectopic pregnancy | ectopic pregnancy during 12 weeks gestation | pregnancy outside the uterine cavity |
| birthweight of newborns | 1 year after FET | the birth weight of newborns |
| serum baseline FSH | day 2-3 of period | baseline FSH of period day 2-3 |
| estradiol level on the trigger day | 2 days before oocyte retrieval | — |
| progesterone level on the trigger day | 2 days before oocyte retrieval | — |
| estradiol and progesterone levels in the follicular fluid | 1 year after FET | estradiol and progesterone levels in the follicular fluid |
| miscarriage | 22 weeks of pregnancy | clinically recognised pregnancy loss before 22 weeks of pregnancy. |
| multiple pregnancy | multiple pregnancy beyond gestation 12 weeks | more than one intrauterine sacs on scanning |
Countries
China
Outcome results
None listed