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: 14.1Level: 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-CZ

Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary: Not available

Detailed Description: Not available

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

Primary Outcome Measures

Name	Time	Method
Main Objective: – To evaluate the effect of barusiban compared to placebo on implantation rate in IVF/ICSI patients;Secondary Objective: – To evaluate the effect of barusiban compared to placebo on pregnancy rates<br>– To explore the pharmacokinetics of subcutaneous administration of barusiban<br>– To evaluate the safety profile of barusiban<br>– To evaluate the local tolerability of barusiban;Primary end point(s): – Ongoing implantation rate (number of intrauterine viable fetuses 10-11 weeks after transfer divided by number of embryos/blastocysts transferred);Timepoint(s) of evaluation of this end point: – Ongoing implantation rate:10-11 weeks after transfer

Secondary Outcome Measures