A Randomised Study Comparing Two Different Regimens of Ovarian Stimulation Using Pergoveris and Cetrorelix for Controlled Ovarian Superovulation in Assisted Conception Treatment. - Pergoveris and Cetrorelix for controlled ovarian stimulatio

Phase 1

• Conditions: Subfertility; MedDRA version: 12. Level: LLT Classification code 10042391 Term: Subfertility

• Registration Number: EUCTR2009-012847-40-GB
• Lead Sponsor: HS Lothian

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-20
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

-healthy female;
-aged 21 – 38 years;
- undergoing IVF treatment for unexplained, tubal or male factor subfertility;
-regular menstrual cycles (24-35 days);
-both ovaries present (no previous surgery on ovaries);
-able to understand protocol;
-able to give informed consent.

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-polycystic ovarian syndrome
-endometriosis (severe) requiring treatment;
-serum AMH level < 6 pmol/l at screening;
-known history of poor ovarian response during assisted conception treatment;
-3 or more failed IVF/ICSI cycles (defined as failure to achieve pregnancy and live birth);
-allergic to investigational compounds;
-contraindication to any of the study medication
-lactation;
-use of depot hormonal contraceptive within a period of six months or use of oral contraceptive within eight weeks prior to start of COS treatment;
-hypertension (systolic >155 mm Hg; diastolic >90mmHg);
-history of alcohol or drug abuse;
-abnormal biochemistry/haematology results at screening;
-administration of investigational drugs within 20 days of Screening
-not able to give informed consent.

Study & Design

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