Prospective randomized trial concerning three different stimulation methods in IVF/ICSI treatment in poor responders

Phase 1

• Conditions: Subfertility; MedDRA version: 14.1Level: LLTClassification code 10016465Term: Fertility female decreasedSystem Organ Class: 10038604 - Reproductive system and breast disorders; MedDRA version: 14.1Level: LLTClassification code 10016398Term: Female infertilitySystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2012-001708-39-BE
• Lead Sponsor: niversity Hospital Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-17
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Patients <43 years old, BMI=30 and a normal uterine cavity (demonstrated by ultrasound, hysterosalpingography, hysteroscopy) for whom an IVF/ ICSI treatment is indicated and who were 'Poor Responders' (POR) in the previous IVF/ICSI cycle, meaning that at least two of the following three features must be present:

=40 years or any other risk factor for POR;
=3 oocytes in the previous IVF/ICSI cycle with a conventional stimulation protocol
an abnormal ovarian reserve test (i.e. AFC <5–7 follicles or AMH <0.5–1.1 ng/ml)

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 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients undergoing a treatment with Preimplantation Genetic Diagnosis or ICIS with cryo-TESE

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to test the hypothesis that ovarian stimulation with Corifollitropin alfa FSH with a prolonged activity) in women who showed a poor ovarian repsonse in the previous IVF/ICSI cycle, results in a higher chance on a live birth;Secondary Objective: Pregnancy rate per IVF/ICSI cycle started in the trial<br>Number of oocytes per IVF/ICSI cycle started in the trial<br>Percentage of cycles withou oocyte aspiration due to abscence of ovarian repsonse<br>Embryo quality (absolute number and percentage of good quality embryos);Primary end point(s): Percentage of live births per IVF/ICSI cycle started in the trial;Timepoint(s) of evaluation of this end point: About 9 months after the start of the IVF/ICSI cycle in case of a pregnancy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Pregnancy rate per IVF/ICSI cycle in the trial<br>Number of oocytes per IVF/ICSI cycle in the trial<br>Percentage of cycles without oocyte aspiration due to absence of ovarian response<br>Embyro quality (absolute number and percentage of good quality embryos;Timepoint(s) of evaluation of this end point: The result 'pregnant/not pregnant' is determinated at maximum 8 weeks after the start of the IVF/ICIS cycle<br>Number of oocyte is registered after a maximum of 22 days of ovarian stimulation<br>The 'occurence/non occurence of oocyte aspiration due to the absence of ovarina response' is registered after a maximum of 22 days of ovarian stimualtion<br>Embryo quality is registered until a maximum of 7 days after the oocyte aspiration