Reduction of progesterone elevation at trigger in poor responder Bologna’ criteria patients after controlled ovarian stimulation with long acting standard stimulation protocol compared with conventional daily protocol: a single center prospective randomized Fase IV trial

Phase 1

• Conditions: Patient with poor ovarian response; MedDRA version: 20.0Level: LLTClassification code 10021935Term: Infertility, female, associated with anovulationSystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2020-004329-21-IT
• Lead Sponsor: OSPEDALE SAN RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

Women undergoing IVF cycle, aged between 25 and 42 years, 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, FSH on cycle day 3 < 20 IU/L, who have signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

BMI >25 or <18, PCOS, history of untreated autoimmune, endocrine or metabolic disorders, ovarian cystectomy or oophorectomy, FSH >= 20 lU/L, Kidney diseases, Malignant gynecological cancer, Hypersensitivity to investigated drugs , contraindication for pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The overarching objective of this research is to generate clinical evidence to argue the bene-fits of long acting stimulation protocol compared to the daily stimulation protocol in poor ovarian responders.;Secondary Objective: To reduce the freeze-all IVF cycles due to prema-ture PE<br>To increase the n° of oocytes collected at ovum re-trieval<br>To increase the fertilization rate<br>To increase the n° of embryo available<br>To increase the pregnancy rate<br>To increase the ongoing pregnancy rate (vital fetus at 20 weeks of gestation);Primary end point(s): Reduction in the proportion of subjects with progesterone > 1.1 ng/ml on the day of triggering (day + 13) in the experimental group (Expected 5%) compared to the control group (Expected 25%);Timepoint(s) of evaluation of this end point: on the day of triggering (day + 13)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Comparison of the n° of oocytes collected between the two Arms at day + 14; Percentage of fertilized oocytes at day +15 of ex-perimental group compared to the control group; Total n° of embryos obtained at day +17 of experi-mental group compared to the control group; Percentage of positive pregnancy test at day +31 of experimental group compared to the control group; Percentage of abortion at week 20th of experimental group compared to the control group; Total n° of embryos cryopreserved at day +21 of ex-perimental group compared to the control group;Timepoint(s) of evaluation of this end point: day + 14; day +15; day +17; day +31; week 20th; day +21