IMPLANT2: Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI

• Sponsor: ObsEva SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03081208
• Collaborator: (none)
• Enrollment: 810
• Locations: 43
• Arms: 2
• Actual Duration (Months): 23.5
• Patients Per Site: 18.8
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Nolasiban 900mg; Drug: Placebo	Phase 3

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).

Study Design

• Study Type: Interventional
• 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: Mar 6, 2017
• Actual Primary Completion Date: Mar 21, 2018
• Actual Study Completion Date: Feb 19, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Live birth [Up to 42 weeks of gestation]

   Live birth after 24 weeks of gestation

2. Miscarriage [From 6 weeks post ET to 24 weeks gestation]

   Any clinical pregnancy that does not result in a live birth prior 24 weeks

3. Intra-uterine pregnancy at 6 weeks [6 weeks post ET]

   Intra-uterine pregnancy with fetal heart beat at 6 weeks post ET day

4. Positive blood pregnancy test [14 days post OPU]

   Positive blood pregnancy test at 14 days post oocyte pick-up (OPU)

Other Outcome Measures

1. Adverse events [Through study completion, up to 11 months]

   Frequency and severity of treatment emergent adverse events

2. Neonatal assessments [Birth of infant until 28 days]

   Incidence of any malformation or any significant morbidity during the neonatal period

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 36 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigator ID 1001	Brussels		Belgium
2	Investigator ID 1002	Brussels		Belgium
3	Investigator ID 1003	Brussels		Belgium
4	Investigator ID 1004	Brussels		Belgium
5	Investigator ID 1107	Olomouc		Czechia
6	Investigator ID 1101	Prague		Czechia
7	Investigator ID 1102	Prague		Czechia
8	Investigator ID 1103	Prague		Czechia
9	Investigator ID 1104	Prague		Czechia
10	Investigator ID 1108	Prague		Czechia
11	Investigator ID 1109	Teplice		Czechia
12	Investigator ID 1106	Zlin		Czechia
13	Investigator ID 1204	Copenhagen		Denmark
14	Investigator ID 1205	Herlev		Denmark
15	Investigator ID 1202	Hvidovre		Denmark
16	Investigator ID 1203	Skive		Denmark
17	Investigator ID 1301	Tartu		Estonia
18	Investigator ID 1303	Tartu		Estonia
19	Investigator ID 1401	Helsinki		Finland
20	Investigator ID 1402	Helsinki		Finland
21	Investigator ID 1403	Oulu		Finland
22	Investigator ID 1501	Heidelberg		Germany
23	Investigator ID 1502	Lübeck		Germany
24	Investigator ID 1504	Mainz		Germany
25	Investigator ID 1503	Marburg		Germany
26	Investigator ID 1601	Budapest		Hungary
27	Investigator ID 1604	Budapest		Hungary
28	Investigator ID 1603	Pécs		Hungary
29	Investigator ID 1602	Tapolca		Hungary
30	Investigator ID 1701	Białystok		Poland
31	Investigator ID 1703	Białystok		Poland
32	Investigator ID 1705	Białystok		Poland
33	Investigator ID 1702	Katowice		Poland
34	Investigator ID 1704	Szczecin		Poland
35	Investigator ID 1706	Warsaw		Poland
36	Investigator ID 1801	Barakaldo		Spain
37	Investigator ID 1805	Barcelona		Spain
38	Investigator ID 1808	Barcelona		Spain
39	Investigator ID 1809	Leioa		Spain
40	Investigator ID 1804	Madrid		Spain
41	Investigator ID 1807	Madrid		Spain
42	Investigator ID 1811	Sevilla		Spain
43	Investigator ID 1806	Valencia		Spain

Sponsors and Collaborators

• ObsEva SA

Investigators

• Study Director: ObsEva SA, Geneva

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ObsEva SA
• ClinicalTrials.gov Identifier: NCT03081208
• Other Study ID Numbers: 16-OBE001-005
• First Posted: Mar 16, 2017
• Last Update Posted: Dec 23, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ObsEva SA: IVF; ICSI
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Dec 23, 2019