Embryo implantation in women undergoing IVF with Day 5 fresh embryo transfer cycles MedDRA version: 20.0 Level: LLT Classification code 10073184 Term: Embryo transfer System Organ Class: 100000004865
Conditions
Interventions
Product Name: nolasiban
Product Code: OBE001 50mg
Pharmaceutical Form: Dispersible tablet
INN or Proposed INN: Nolasiban
CAS Number: 1477482-19-1
Current Sponsor code: OBE001
Other descriptive name: N
Sponsors
ObsEva SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject must provide written informed consent prior to initiation of any study-related procedures, as shown by a signature on the Informed Consent Form. 2. The subject must be aged 18 years to 37 years inclusive at screening. 3. The subject must be indicated for IVF/ICSI in the context of assisted reproductive technology (ART). 4. The subject must have undergone not more than one unsuccesful (no good quality embryos produced or negative ßhCG test) controlled ovarian hyperstimulation (COH) for IVF or ICSI (whether fresh and/or several frozen ET resulted from that COH). Any attempts before a prior clinical pregnancy (observed embryo with heart beat) do not count. 5. If the subject had one unsuccessful COH cycle, as described in inclusion criteria 4 above, they must have obtained at least one good quality embryo for transfer. 6. The subject must in the current COH cycle for IVF/ICSI follow a GnRH antagonist protocol with or without pre-treatment with an oral contraceptive pill or estradiol. 7. The subject must in the current COH cycle for IVF/ICSI receive a single injection of hCG for triggering final follicular maturation. 8. The subject must in the current COH cycle for IVF/ICSI receive a luteal phase support with vaginal micronized progesterone at 600 mg per day beginning the morning after OPU. 9. The subject must undergo oocyte retrieval for IVF/ICSI and subsequent fresh transfer on day 5 post-OPU day. 10. The subject must have at least one good quality embryo in the current COH cycle. 11. The subject is scheduled for a single fresh embryo transfer in the current COH cycle. 12. The subject must have at least 1 functional ovary. 13. The subject must have a BMI = 18 kg/m2 and = 38 kg/m2. 14. The subject must be able to communicate well with the investigator and research staff and to comply with the requirements of the study protocol. 15. The subject must agree to participate in the infant follow-up if she becomes pregnant. 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 820 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. The subject undergoes a frozen-thawed embryo transfer in the current transfer. 2. The subject undergoes ET of an embryo from a donor egg in the current transfer. 3. The subject’s partner required surgical testicular sperm extraction in that cycle. 4. Use of assisted hatching and/or use of adherence compounds (e.g. EmbryoGlue®) for the embryo to be transferred in the study. 5. The subject or partner has a known abnormal karyotype or the subject has known acquired or congenital thrombophilia disease. 6. Any preimplantation genetic testing of the transferred embryo. 7. The subject has any condition, including findings in the medical history or in the pre-trial assessments, which in the opinion of the investigator constitutes a risk or a contraindication for the participation of the subject in the trial or that could interfere with the trial objectives, conduct or evaluation. 8. The subject has any clinically significant abnormality in the results of the screening safety laboratory tests, including AST, ALT, GGT, alkaline phosphatase or total bilirubin above twice upper limit of normal. In case of isolated GGT increase, a single re-test is allowed. 9. The subject has a serum P4 level greater than 1.54 ng/mL prior to hCG administration. 10. The subject had more than 20 oocytes retrieved in the current Controlled Ovarian Hyperstimulation (COH) cycle. 11. Subject is known to have i) impaired ovarian reserve or ii) biomarker predictor of poor response e.g. FSH, AMH, AFC. 12. The subject has any significant abnormality relevant to the ART procedure and outcome, in the results of a gynecological examination within 6 months of screening, which in the opinion of the investigator could interfere with the trial objectives, conduct or evaluation (e.g. significant uterine anomaly, communicating hydrosalpinx or fibroid(s) documented during ultrasound). 13. The subject has diagnosed severe endometriosis (stage III or IV) and/or adenomyosis. 14. The subject is at significant risk of severe ovarian hyper stimulation syndrome (OHSS). 15. The subject has any history of uncontrolled hypertension and/or heart disease. 16. The subject has known positive results from virology tests for hepatitis B surface antigen (HBsAg) (not due to vaccination), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) 1 or 2. However, subjects who have resolved hepatitis B infection may be enrolled in the study. 17. The subject is prone to frequent, severe hypersensitivity to drugs. 18. The subject has been administered any experimental drug in the 12 weeks before dosing. 19. The subject is likely to require treatment with drugs that are not permitted during the study from day 4 after OPU up to the Week 2 visit (OPU day + 14 days) such as: Drugs with utero-relaxant properties: calcium channel blockers, beta-sympathomimetic agents, nitroglycerine, parenteral magnesium sulfate (MgSO4), potassium channel openers, NSAIDs. 20. The subject has autoimmune disease (e.g. lupus, rheumatoid arthritis) that is being medically treated. 21. The subject has a history of, or known current (within twelve months) problems with alcohol or drug abuse. 22. The subject has a history of recurrent pregnancy loss defined as 3 or more consecutive pregnancy losses including biochemical pregnancies. Miscarriage prior to a subsequent live birth does not count. 23. The subject has a history of difficult transfers (e.g. tenaculum use or blood stained catheter).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to confirm the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the ongoing clinical pregnancy rate at 10 weeks post-embryo transfer (ET) day.;Secondary Objective: The secondary objective is to assess the efficacy of a single oral 900 mg dose of nolasiban versus placebo to increase the live birth rate.;Primary end point(s): Ongoing pregnancy defined as an intra-uterine pregnancy with fetal heart beat at 10 weeks post-ET day.;Timepoint(s) of evaluation of this end point: As soon as the last subject has completed week 10 and all data have been locked, the treatment groups will be unblinded, and the results up to the Week 10 visit will be analysed and described in a Clinical Study Report. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Live birth after 24 weeks of gestation.;Timepoint(s) of evaluation of this end point: after the data from the pregnancy outcome, newborn, and neonatal health at 28 days are available and the information from the ASQ-3 questionnaires (at 6 months after birth corrected for gestational age at birth.) has been collected | — |
Countries
Belgium, Canada, Czech Republic, Denmark, Estonia, Finland, Germany, Hungary, Poland, Russian Federation, Spain
Contacts
Public ContactClinical Trial Director
ObsEva SA
Outcome results
None listed