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

University of Turin

Status: Completed

Conditions: Fertility Disorders

Treatments: Drug: Corifollitropin Alfa

Study type: Interventional

Funder types: Other

Identifiers

NCT03816670

IIS#53736

Details and patient eligibility

About

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

Full 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

Enrollment: 113 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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113 participants in 6 patient groups

poor responders day 2

Experimental group

Description:

"poor responders" women stimulated with CF from day 2 of menstrual cycle

Treatment:

Drug: Corifollitropin Alfa

poor responders day 4

Experimental group

Description:

"poor responders" women stimulated with CF from day 4 of menstrual cycle

Treatment:

Drug: Corifollitropin Alfa

normal responders day 2

Experimental group

Description:

"normal responders" women stimulated with CF from day 2

Treatment:

Drug: Corifollitropin Alfa

normal responders day 4

Experimental group

Description:

"normal responders" women stimulated with CF from day 4

Treatment:

Drug: Corifollitropin Alfa

high responders day 2

Experimental group

Description:

"high responders" women stimulated with CF from day 2

Treatment:

Drug: Corifollitropin Alfa

high responders day 4

Experimental group

Description:

"high responders" women stimulated with CF from day 4

Treatment:

Drug: Corifollitropin Alfa