Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF

• Register: ClinicalTrials.gov
• Last refreshed on: 20 September 2021
• Main ID: NCT03758885
• Date of registration: 28/11/2018
• Prospective Registration: Yes
• Primary sponsor: ObsEva SA
• Public title: Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF IMPLANT4
• Scientific title: A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Safety and Efficacy of a Single Oral Administration of Nolasiban to Increase On-going Pregnancy Rate Following Fresh Single Blastocyst Transfer Resulting From IVF
• Date of first enrolment: January 10, 2019
• Target sample size: 820
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03758885
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, Czechia, Denmark, Estonia, Germany, Hungary, Poland, Russian Federation, Spain

Key inclusion & exclusion criteria

Inclusion Criteria:

- Indicated for IVF/ICSI in the context of assisted reproductive technology (ART)

- Follow a gonadotropin releasing hormone (GnRH) antagonist protocol, single injection
of human chorionic gonadotropin (hCG) for triggering final follicular maturation and
luteal support with vaginal micronized progesterone.

- Single fresh D5 embryo transfer

Exclusion Criteria:

- Frozen-thawed embryo transfer

- Donor egg in the current transfer

- More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle

- Serum P4 greater than 1.5 ng/mL prior to hCG administration



Age minimum: 18 Years
Age maximum: 37 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Infertility

Intervention(s)

Drug: Nolasiban

Drug: Placebo

Primary Outcome(s)

Ongoing pregnancy with fetal heart beat at 10 weeks [Time Frame: 10 weeks post ET day]

Secondary Outcome(s)

Pregnancy rate at 14 days post Oocyte Pick-up (OPU) [Time Frame: 14 days post OPU]

Plasma concentrations of nolasiban [Time Frame: 3.5 hours, 5 hours and at 7 hours (latest 72 hours) after nolasiban administration]

Live birth [Time Frame: 24 to 40 weeks of gestation]

Clinical pregnancy at 6 weeks post ET day [Time Frame: 6 weeks post ET]

Pregnancy loss [Time Frame: 6 weeks post ET to 24 weeks gestation]

Secondary ID(s)

18-OBE001-010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors