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

Not Applicable

Completed

• Conditions: Fertility Disorders
• Interventions: Drug: Corifollitropin Alfa

• Registration Number: NCT03816670
• Lead Sponsor: University of Turin, Italy

Brief Summary

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

The investigators hypothesize that:

1. 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.

2. 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.

3. Oocytes and embryos obtained using CF-alfa late start will have comparable morphological features and development potential than those obtained with CF-alfa standard.

4. 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

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2018-04-30
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-24
• Last Update Submitted: 2019-01-24
• Study First Posted: 2019-01-25
• Last Update Posted: 2019-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 113

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal responders day 2	Corifollitropin Alfa	"normal responders" women stimulated with CF from day 2
high responders day 2	Corifollitropin Alfa	"high responders" women stimulated with CF from day 2
poor responders day 4	Corifollitropin Alfa	"poor responders" women stimulated with CF from day 4 of menstrual cycle
high responders day 4	Corifollitropin Alfa	"high responders" women stimulated with CF from day 4
poor responders day 2	Corifollitropin Alfa	"poor responders" women stimulated with CF from day 2 of menstrual cycle
normal responders day 4	Corifollitropin Alfa	"normal responders" women stimulated with CF from day 4

Primary Outcome Measures

Name	Time	Method
number of retrieved oocytes	1 year	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

Trial Locations

Locations (1)

Physiopathology of Reproduction and IVF Unit, S. Anna Hospital; 🇮🇹 Torino, Italy