Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03081208

Acronym

IMPLANT2

Enrollment

810

Registered

2017-03-16

Start date

2017-03-06

Completion date

2019-02-19

Last updated

2019-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

IVF, ICSI

Brief summary

The primary objective of this study is to confirm the efficacy of a single oral 900mg dose of nolasiban to increase the ongoing clinical pregnancy rate at 10 weeks post embryo transfer (ET) day.

Detailed description

The study is a prospective, randomized, parallel group, double-blind, placebo-controlled study to confirm the efficacy and the safety of the oxytocin receptor antagonist, nolasiban, in 760 women undergoing fresh embryo transfer following in vitro fertilisation (IVF) or intra-cytoplasmic sperm injection (ICSI).

Interventions

DRUGNolasiban 900mg

Nolasiban dispersible tablets for single oral administration

DRUGPlacebo

Placebo dispersible tablets for single oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double Blind

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 36 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Intra-uterine pregnancy with fetal heart beat at 10 weeks	10 weeks post ET day	Intra-uterine pregnancy with fetal heart beat at 10 weeks post embryo transfer day

Secondary

Measure	Time frame	Description
Miscarriage	From 6 weeks post ET to 24 weeks gestation	Any clinical pregnancy that does not result in a live birth prior 24 weeks
Live birth	Up to 42 weeks of gestation	Live birth after 24 weeks of gestation
Intra-uterine pregnancy at 6 weeks	6 weeks post ET	Intra-uterine pregnancy with fetal heart beat at 6 weeks post ET day
Positive blood pregnancy test	14 days post OPU	Positive blood pregnancy test at 14 days post oocyte pick-up (OPU)

Other

Measure	Time frame	Description
ASQ-3	6 months after term	Ages and Stages Questionnaire-3 (ASQ-3) domain score(s) at 6 months, adjusted for gestational age at birth
Neonatal assessments	Birth of infant until 28 days	Incidence of any malformation or any significant morbidity during the neonatal period
Adverse events	Through study completion, up to 11 months	Frequency and severity of treatment emergent adverse events

Countries

Belgium, Czechia, Denmark, Estonia, Finland, Germany, Hungary, Poland, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026