A randomised, placebo-controlled, double-blind, parallel groups, multinational, multicentre trial assessing the effect of barusiban administered subcutaneously on the day of transfer on implantation and pregnancy rates in IVF/ICSI patients

• Conditions: Infertility female; MedDRA version: 16.1Level: PTClassification code 10021928Term: Infertility femaleSystem 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: EUCTR2012-001622-10-PL
• Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-09
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 340

Inclusion Criteria

- Women aged 18-37 years
- Women who have undergone 2-4 previous fresh IVF/ICSI cycles that all resulted in a negative ßhCG test, despite transfer of at least one embryo/blastocyst of good quality
- Women who have in the current controlled ovarian stimulation cycle for IVF/ICSI followed the long GnRH agonist or GnRH antagonist protocol, received hCG for triggering of final follicular maturation and have undergone oocyte retrieval for IVF/ICSI with the purpose of fresh transfer
- Retrieval of at least 6 oocytes in the current controlled ovarian stimulation cycle
- Subjects should have at least one embryo of good quality available for transfer on day 3, or one expanded or hatching/hatched blastocyst available for transfer on day 5
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 340
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- A total of 6 or more controlled ovarian stimulation cycles for IVF/ICSI
- Abnormal karyotype
- Uterine pathology or hydrosalpinx
- Diagnosed with acquired or congenital thrombophilia disease

Study & Design

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