Infertility female MedDRA version: 14.1 Level: PT Classification code 10021928 Term: Infertility female System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 – To explore the pharmacokinetics of subcutaneous administration of barusiban – To evaluate the safety profile of barusiban – 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): – Ongoing pregnancy rate (at least one intrauterine viable fetus 10-11 weeks after transfer) – Implantation rate (number of intrauterine gestational sacs with fetal heart beat 5-6 weeks after transfer divided by number of embryos/blastocysts transferred) – Clinical pregnancy (with fetal heart beat) rate (at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer) – Positive ßhCG rate (positive serum ßhCG test 13-15 days after transfer) – Serum barusiban concentration at the expected tmax – Frequency and intensity of adverse events – Frequency and intensity of injection site reactions (redness, pain, itching, swelling and bruising) assessed immediately and 30 min after each administration of barusiban / placebo;Timepoint(s) of evaluation of this end point: – Ongoing pregnancy rate: 10-11 weeks after transfer – Implantation rate: 5-6 weeks after transfer – Clinical pregnancy: 5-6 weeks after transfer – Positive ßhCG rate:13-15 days after transfer – Serum barusiban concentration: 30 min after last barusiban / placebo dose – Frequency and intensity of adverse events: from signed informed consent to end-of-trial – Frequency and intensity of injection site reactions: immediately and 30 min after each administration of barusiban / placebo | — |
Countries
Australia, Belgium, Canada, Czech Republic, Poland, Spain
Contacts
Public ContactClinical Development Support
Ferring Pharmaceuticals A/S
Outcome results
None listed