Trial · Interventional
CompletedPhase 3Registry dataChina
1 trial · 1 completed
Live Birth Rate Between PPOS and GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response
NCT044147614 Jun 2020 to 10 Oct 2022
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Active comparator
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.
Experimental
PPOS group
Women will receive oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger.
Outcomes the sponsor listed as primary.
live birth rate
Time frame · deliveries ≥22 weeks gestation with heartbeat and breath
live birth rate of the first frozen embryo transfer cycle
positive serum hCG
Time frame · 2 weeks after FET
serum β-hCG ≥10 mIU/mL of the first FET
clinical pregnancy
Time frame · 6 weeks' gestation
presence of intrauterine gestational sac by trans-vaginal ultrasound at 6 gestational weeks of the first FET
biochemical pregnancy
Time frame · 6 weeks' gestation
positive serum hCG not followed by clinical pregnancy of the first FET
implantation rate
Time frame · 6 weeks' gestation
the number of gestational sacs per blastocyst transferred of the first FET
ongoing pregnancy
Time frame · 12 weeks' gestation
a viable pregnancy beyond 12 weeks' gestation of the first FET
cumulative live birth
Time frame · 2 years' after FET
cumulative live birth within 6 months of randomization
number of oocytes retrieved
Time frame · 1 day after oocyte retrieval
number of oocytes retrieved
number and grading of blastocysts
Time frame · 1 week after oocyte retrieval
number and grading of blastocysts suitable for biopsy and freezing
multiple pregnancy
Time frame · multiple pregnancy beyond gestation 12 weeks
more than one intrauterine sacs on scanning
ectopic pregnancy
Time frame · ectopic pregnancy during 12 weeks gestation
pregnancy outside the uterine cavity
birthweight of newborns
Time frame · 1 year after FET
the birth weight of newborns
serum baseline FSH
Time frame · day 2-3 of period
baseline FSH of period day 2-3
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
Time frame · 1 year after FET
estradiol and progesterone levels in the follicular fluid
miscarriage
Time frame · 22 weeks of pregnancy
clinically recognised pregnancy loss before 22 weeks of pregnancy.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2019
Beguería et al. 2019Human reproduction (Oxford, England)cited by 80
PMID 30927417DOI 10.1093/humrep/dez034PUB-30927417
References listed at the registry that are not in PepBank. They link to PubMed.
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