OBE001 in women undergoing embryo transfer in the context of IVF-ICSI
Research type
Research Study
Full title
A phase 2, double-blind, dose-finding, placebo-controlled study to assess the safety and efficacy of a single oral administration of OBE001 to improve embryo implantation following IVF or ICSI.
IRAS ID
161196
Contact name
Nitish NARVEKAR
Contact email
Sponsor organisation
ObsEva SA
Eudract number
2014-002254-40
Research summary
In spite of spectacular progress in assisted reproduction technology over the past 20 years, the overall effectiveness of even the most advanced treatments such as In Vitro Fertilisation (IVF)/embryo transfer (IVF/ET) is relatively low, averaging at about 30% live births per treatment cycle. The success of ET depends on the quality of embryo(s) and how well the uterus receives the embryo. Excessive uterine contractions may decrease implantation rates in IVF cycles as contractile activity might expel embryos from the uterus.
The uterus contains structures called oxytocin and vasopressin receptors and when oxytocin and vasopressin bind to their receptors, the uterus contracts. OBE001 is an oxytocin receptor antagonist, which means it blocks oxytocin from working, but it also has some effect blocking vasopressin activity. The pharmaceutical company ObsEva S.A. is investigating if this new medicine will be able to help women to get pregnant by lowering the uterus contractions prior to the transfer of their embryo(s) in their uterus. Currently, there are no medicines available for that purpose.
The study will assess the safety and efficacy of a single oral administration of OBE001 to improve embryo implantation following IVF or Intra-Cytoplasmic Sperm Injection (ICSI). 100 mg, 300 mg and 900 mg doses of the drug will be compared to placebo in up to 240 healthy women undergoing oocyte retrieval for IVF/ICSI from across Europe (randomised in a 1:1:1:1 ratio). Participants will be in the study for up to 22 weeks, visiting the hospital 3, 4 or 5 times, depending on whether they get pregnant. Participants will be recruited and screened within 12 weeks before oocyte collection (Visit 1) with visit 2 (study drug administration) 3 days after oocytes collection. Blood and urine collection will be performed throughout the study, as will gynecological examination and ultrasound, and an ECG at screening.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
14/EE/1115
Date of REC Opinion
22 Sep 2014
REC opinion
Further Information Favourable Opinion