Randomized, open-label, single centre study on ovarian stimulation in ART poor responders treated with recombinant FSH in association with recombinant LH.

• Conditions: Female sterility; MedDRA version: 14.1Level: LLTClassification code 10016422Term: Female sterilitySystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2010-022032-37-IT
• Lead Sponsor: CASA DI CURA ABANO TERME POLISPECIALISTICA E TERMALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-28
• Last Update Posted: 29 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

- infertile patients aged 35 to 43 years inclusive; - regular cycles of 26-33 days; - tubal or male sterility; - idiopathic sterility only if exceeding 2 years; - no ovarian stimulation of any kind during the previous 3 months; - FSH on 3rd day >10 and < 15 mIU/mL; - previous FIVET or ICSI treatments with poor response to ovarian stimulation (both <5 oocytes collected, large amounts of gonadotrophins required); - written informed consent given before any trial-related activities are carried out.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- infertile patients aged up to 34 and >= 44 years; - hypo-hypo patients; - participation in another clinical trial within the past 30 days; - known hypersensitivity to the trial treatment, or the comparator drug; - legal incapacity or limited legal capacity; - any clinically important systemic disease (e.g. insulin-dependent diabetes mellitus, epilepsy, serious migraine, intermittent purpura, hepatic, renal or cardiovascular disease, serious corticoid-dependent asthma) wich constitutes a controindication to gonadotropin use.

Study & Design

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