Corifollitropin Alpha and Ovarian Response

• Status: Completed
• Trial end date: 2019-01-31
• Target enrollment: 0
• Participant gender: Female

Summary

Objective: To study whether an administration of corifollitropin alpha modifies the follicular cohort, measured by Follicular Output Rate (FORT), compared to human menopausal gonadotropin (HMG), in infertile patients undergoing in vitro fertilisation (IVF).

M/M: 306 infertile patients undergoing in vitro fertilisation (IVF). Ovarian stimulation protocol will be performed with a single dose of 100 μg (<60kg) or 150 μg (≥60kg) corifollitropin alpha in group 1 (n=147), and 150-300 IU/day human menopausal gonadotropin (HMG) according to age, antimullerian hormone (AMH) level and antral follicle count (AFC) in group 2 (n=150).

Moreover, FORT will be calculated as the ratio of pre-ovulatory follicle (16-22 mm in diameter) count on day of HCG×100/small antral follicle (3-8 mm) count at baseline.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital de Clinicas de Porto Alegre
• Treatments: Menotropins

Criteria

Inclusion Criteria:

• Regular menstrual cycles;

• Body mass index (BMI) of <33.0 kg/m².

Exclusion Criteria:

• Previous ovarian surgery;

• Current diagnosis of polycystic ovarian syndrome (PCOS) or other endocrinopathies;

• History of autoimmune or metabolic disorders.