Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI (IMPLANT2)
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ClinicalTrials.gov Identifier: NCT03081208 |
Recruitment Status :
Completed
First Posted : March 16, 2017
Last Update Posted : December 23, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infertility | Drug: Nolasiban 900mg Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 810 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Double Blind |
Primary Purpose: | Treatment |
Official Title: | A Phase 3, Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of a Single Oral Administration of Nolasiban to Improve Pregnancy Rates Following IVF or ICSI in Day 3 and Day 5 Fresh Embryo Transfer Cycles |
Actual Study Start Date : | March 6, 2017 |
Actual Primary Completion Date : | March 21, 2018 |
Actual Study Completion Date : | February 19, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: Nolasiban 900 mg |
Drug: Nolasiban 900mg
Nolasiban dispersible tablets for single oral administration |
Placebo Comparator: Placebo |
Drug: Placebo
Placebo dispersible tablets for single oral administration |
- Intra-uterine pregnancy with fetal heart beat at 10 weeks [ Time Frame: 10 weeks post ET day ]Intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day
- Live birth [ Time Frame: Up to 42 weeks of gestation ]Live birth after 24 weeks of gestation
- Miscarriage [ Time Frame: From 6 weeks post ET to 24 weeks gestation ]Any clinical pregnancy that does not result in a live birth prior 24 weeks
- Intra-uterine pregnancy at 6 weeks [ Time Frame: 6 weeks post ET ]Intra-uterine pregnancy with fetal heart beat at 6 weeks post ET day
- Positive blood pregnancy test [ Time Frame: 14 days post OPU ]Positive blood pregnancy test at 14 days post oocyte pick-up (OPU)
- Adverse events [ Time Frame: Through study completion, up to 11 months ]Frequency and severity of treatment emergent adverse events
- Neonatal assessments [ Time Frame: Birth of infant until 28 days ]Incidence of any malformation or any significant morbidity during the neonatal period
- ASQ-3 [ Time Frame: 6 months after term ]Ages and Stages Questionnaire-3 (ASQ-3) domain score(s) at 6 months, adjusted for gestational age at birth

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Ages Eligible for Study: | 18 Years to 36 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Key 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 phase support with vaginal micronized progesterone.
- Single, fresh D3 or D5 embryo transfer
Key Exclusion Criteria:
- Frozen-thawed embryo transfer
- More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle
- Serum P4 greater than 1.5 ng/mL on the day of hCG administration

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081208

Study Director: | ObsEva SA | Geneva |
Responsible Party: | ObsEva SA |
ClinicalTrials.gov Identifier: | NCT03081208 |
Other Study ID Numbers: |
16-OBE001-005 |
First Posted: | March 16, 2017 Key Record Dates |
Last Update Posted: | December 23, 2019 |
Last Verified: | December 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
IVF ICSI |
Infertility |