A Phase 3 interventional study of Progesterone and GnRH Antagonist in IVF, GnRH Antagonist and PPOS, sponsored by ShangHai Ji Ai Genetics & IVF Institute. Completed at 1 site in China. Open to female participants aged 20 Years to 43 Years. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by ShangHai Ji Ai Genetics & IVF Institute · Phase 3, Interventional, and Treatment
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.
ShangHai Ji Ai Genetics & IVF Institute is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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.
Drug: GnRH Antagonist
Women will receive oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger.
Drug: Progesterone
oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger
Also known as: medroxyprogesterone, duphaston
GnRH antagonist (Cetrorelix or Ganirelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger
Also known as: Cetrorelix, Ganirelix
live birth rate
live birth rate of the first frozen embryo transfer cycle
Time frame: deliveries ≥22 weeks gestation with heartbeat and breath
positive serum hCG
serum β-hCG ≥10 mIU/mL of the first FET
Time frame: 2 weeks after FET
clinical pregnancy
presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks of the first FET
Time frame: 6 weeks' gestation
biochemical pregnancy
positive serum hCG not followed by clinical pregnancy of the first FET
Time frame: 6 weeks' gestation
implantation rate
the number of gestational sacs per blastocyst transferred of the first FET
Time frame: 6 weeks' gestation
ongoing pregnancy
a viable pregnancy beyond 12 weeks' gestation of the first FET
Time frame: 12 weeks' gestation
cumulative live birth
cumulative live birth within 6 months of randomization
Time frame: 2 years' after FET
number of oocytes retrieved
number of oocytes retrieved
Time frame: 1 day after oocyte retrieval
number and grading of blastocysts
number and grading of blastocysts suitable for biopsy and freezing
Time frame: 1 week after oocyte retrieval
multiple pregnancy
more than one intrauterine sacs on scanning
Time frame: multiple pregnancy beyond gestation 12 weeks
ectopic pregnancy
pregnancy outside the uterine cavity
Time frame: ectopic pregnancy during 12 weeks gestation
birthweight of newborns
the birth weight of newborns
Time frame: 1 year after FET
serum baseline FSH
baseline FSH of period day 2-3
Time frame: day 2-3 of period
estradiol level on the trigger day
Time frame: 2 days before oocyte retrieval
progesterone level on the trigger day
Time frame: 2 days before oocyte retrieval
estradiol and progesterone levels in the follicular fluid
estradiol and progesterone levels in the follicular fluid
Time frame: 1 year after FET
miscarriage
clinically recognised pregnancy loss before 22 weeks of pregnancy.
Time frame: 22 weeks of pregnancy
Plan to share: Yes — Individual participant data that underlie the results after deidentification (text, tables, figures, and appendices) and study protocol will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be available when beginning 3 months and ending 5 years following article publication.
Access criteria: To achieve aims in the approved proposal, researchers who provide a methodologically sound proposal will be shared with. Proposals should be sent to lihe198900@163.com.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Progesterone
ShangHai Ji Ai Genetics & IVF Institute