Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start vs. Corifollitropin-alfa Standard Start in Expected Poor, Normal and High-responders Undergoing IVF

Study Overview
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Brief Summary
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To compare the number of retrieved oocytes in the late start CF-alfa (day 4) versus standard CF-alfa protocols (day 2) in patients undergoing IVF. The primary analysis will be also performed in specific subgroups of patients: expected poor-responders, expected normal responders and expected hyper-responders

Detailed Description
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The investigators hypothesize that: CF-alfa late start (day 4) will show comparable efficacy in terms of number of retrieved oocytes versus standard CF-alfa (day 2) protocol. In certain groups of patients, CF-alfa late start might show differences in terms of efficacy such as in poor-responder patients. CF-alfa late start (day 4) will obtain similar results in terms of vital pregnancy rates with a similar safety profile with respect to COS performed using CF-alfa standard administration (day 2) in expected normal, poor, or high responders. Oocytes and embryos obtained using CF-alfa late start will have comparable morphological features and development potential than those obtained with CF-alfa standard. The patients' satisfaction will possibly be higher using CF-alfa late start than with CF-alfa standard expecially in those patients who will not have the need to add further daily recFSH injections

Official Title
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Prospective Randomized Trial Comparing Corifollitropin-alfa Late Start (Day 4) vs. Corifollitropin-alfa Standard Start (Day 2) in Expected Poor, Normal and High-responders Undergoing IVF/ICSI

Conditions
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Fertility Disorders

Intervention / Treatment
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* Drug: Corifollitropin Alfa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18- 43 years Male or tubal infertility with indication for IVF treatment No PCOS No previous IVF treatments in the past two months No history of previous Ovarian Hyperstimulation Syndrome (OHSS) No previous IVF cycle with more than 30 growing follicles ≥ 11 mm Antral Follicle Count (AFC) <20 No ovarian cyst nor malignant ovarian tumour, breast, uterus or central nervous cancer Exclusion Criteria: AMH < 0.2 ng/ml Età > 43 anni

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: poor responders day 2<br>poor responders women stimulated with CF from day 2 of menstrual cycle | Drug: Corifollitropin Alfa<br>* late start (day 4) vs. corifollitropin-alfa standard start (day 2)<br>|
| Experimental: poor responders day 4<br>poor responders women stimulated with CF from day 4 of menstrual cycle | Drug: Corifollitropin Alfa<br>* late start (day 4) vs. corifollitropin-alfa standard start (day 2)<br>|
| Experimental: normal responders day 2<br>normal responders women stimulated with CF from day 2 | Drug: Corifollitropin Alfa<br>* late start (day 4) vs. corifollitropin-alfa standard start (day 2)<br>|
| Experimental: normal responders day 4<br>normal responders women stimulated with CF from day 4 | Drug: Corifollitropin Alfa<br>* late start (day 4) vs. corifollitropin-alfa standard start (day 2)<br>|
| Experimental: high responders day 2<br>high responders women stimulated with CF from day 2 | Drug: Corifollitropin Alfa<br>* late start (day 4) vs. corifollitropin-alfa standard start (day 2)<br>|
| Experimental: high responders day 4<br>high responders women stimulated with CF from day 4 | Drug: Corifollitropin Alfa<br>* late start (day 4) vs. corifollitropin-alfa standard start (day 2)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of retrieved oocytes | To compare the number of retrieved oocytes in the late start CF-alfa (day 4) versus standard CF-alfa protocols (day 2) in patients undergoing IVF | 1 year |