Reduction of Progesterone Elevation at Trigger in POR After Long Acting COS Compared With Daily COS: a Prospective Randomized Trial
- Registration Number
- NCT04695483
- Lead Sponsor
- IRCCS San Raffaele
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 110
- Indication to IVF treatment
- Normal BMI (18.5-24.9 kg/m2)
- AMH level < 1.1 ng/ml and/or AFC < 5 follicles and/or < 3 oo-cytes retrieved in previous cycle
- Regular menstrual cycles
- Signed informed consent
- Freeze all cycles for abnormal bleeding
- PCOS
- History of untreated autoimmune
- Endocrine or metabolic disorders
- Ovarian cystectomy or oophorectomy
- FSH ≥ 20 lU/L
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Corifollitropin alpha group Corifollitropin alfa Patients treated with Corifollitropin-alpha in a long-acting controlled ovarian stimulation FSH group Follitropin Beta Patients treated with Follitropin beta in a daily controlled ovarian stimulation protocol Corifollitropin alpha group Follitropin Beta Patients treated with Corifollitropin-alpha in a long-acting controlled ovarian stimulation
- Primary Outcome Measures
Name Time Method Premature progesterone elevation day 12 Progesterone \> or equal to 1.1 ng/mL at day of trigger
- Secondary Outcome Measures
Name Time Method Number of oocytes collected at ovum retrieval day 14 Fertilization rate day 15 Percentage of oocytes fertilized
Percentage of freeze-all cycles due to premature progesterone elevation day 12 Pregnancy rate day 30 Beta-HCG positive
Number of embryos available Day 17 Ongoing pregnancy Up to 20 weeks Vital fetus at 20 weeks of gestation
Trial Locations
- Locations (1)
Enrico Papaleo
🇮🇹Milan, Italy