A controlled, assessor-blind, parallel groups, multicentre, multinational trial evaluating the immunogenicity of FE 999049 in repeated cycles of controlled ovarian stimulation in women undergoing an assisted reproductive technology programme

Phase 1

• Conditions: Infertility; MedDRA version: 16.0Level: PTClassification code 10021926Term: InfertilitySystem 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: EUCTR2013-001616-30-BE
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-07
• Last Update Posted: 23 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

Subjects who participated in ESTHER-1 - trial 000004 (COS cycle 1) and failed to achieve an ongoing pregnancy may be included in this trial. Subjects failing to achieve an ongoing pregnancy in COS cycle 2 may be offered to start COS cycle 3 after ensuring that they are still compliant with the eligibility criteria. Continuation to COS cycle 3 is only an option until the required number of subjects have been included (approximately 200).
[COS controlled ovarian stimulation]
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Any clinically relevant changes to any of the eligibility criteria in the previous cycle(s)

Study & Design

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