A Phase 4 interventional study of Corifollitropin alfa and Follitropin Beta in Infertility, sponsored by IRCCS San Raffaele. Completed at 1 site in Italy. Open to female participants aged 25 Years to 42 Years. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by IRCCS San Raffaele · Phase 4, Interventional, and Prevention
The overarching objective of this research is to generate clinical evidence to argue the benefits of long acting stimulation protocol compared to the daily stimulation protocol in poor ovarian responder bologna' criteria patients after controlled ovarian stimulation. Reduction in the proportion of subjects with progesterone > 1.1 ng/ml on the day of triggering (day + 13) in the experimental group compared to the control group is expected.
Each patient will receive a first visit for infertility where will be collected subject history and baseline information, and meet all the inclusion / exclusion criteria. Eligible patients who agreed to participate will be randomized to either long acting standard COS with corifollitropin alpha or standard COS with daily FSH in a fixed GnRH antagonist protocol. All patients will be allowed to participate in the study only once and a written informed consent will be obtained from all, following consultation and before the initiation of the treatment.
The endocrine profile of all the patients will be evaluated by analysis of serum progesterone, 17b-estradiol (E2), FSH and LH at different time points: basal condition, during stimulation, at the hCG day and at pick-up.
Transvaginal follicular aspiration will be performed by ultrasound guidance 36 hours after hCG administration. The day of pick up oocytes will be fertilized with partner's semen; after 3-5 days, on the base of its evolution, embryo will be transferred. 14 days after embryo-transfer a preg-nancy test will be performed. Follow up in case of obtained pregnancy will be done until 20 weeks of gestation and considered as ongoing pregnancy.
The entire duration of the study is 24 months, the follow up of the last patients enrolled will be 6 months.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 110 is close to the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients treated with Corifollitropin-alpha in a long-acting controlled ovarian stimulation
Drug: Corifollitropin alfa · Drug: Follitropin Beta
Patients treated with Follitropin beta in a daily controlled ovarian stimulation protocol
Drug: Follitropin Beta
Controlled ovarian stimulation long-acting protocol
Daily controlled ovarian stimulation protocol
Premature progesterone elevation
Progesterone \> or equal to 1.1 ng/mL at day of trigger
Time frame: day 12
Percentage of freeze-all cycles due to premature progesterone elevation
Time frame: day 12
Number of oocytes collected at ovum retrieval
Time frame: day 14
Fertilization rate
Percentage of oocytes fertilized
Time frame: day 15
Number of embryos available
Time frame: Day 17
Pregnancy rate
Beta-HCG positive
Time frame: day 30
Ongoing pregnancy
Vital fetus at 20 weeks of gestation
Time frame: Up to 20 weeks
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele