Follow-Up Of Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)

Phase 2

Completed

• Conditions: Repeated IVF Failure
• Interventions: Other: Post dosing with Placebo; Biological: Post dosing with NT100

• Registration Number: NCT01978561
• Lead Sponsor: Nora Therapeutics, Inc.

Brief Summary

The purpose of this study is to evaluate pregnancy, delivery, and neonatal outcomes in subjects who maintain ongoing clinical pregnancies through Week 10 of gestation in NT-03.

Detailed Description

NT-04 is a follow-up study that will include subjects who received at least one dose of study drug and maintain ongoing clinical pregnancies through Week 10 of gestation during NT-03. NT-04 does not involve the administration of study drug treatment.

In NT-03, subjects who achieve an ongoing clinical pregnancy at Week 8 of gestation will undergo a repeat transvaginal ultrasound (TVU) at Week 10 of gestation (4 weeks after last dose of study drug). Subjects who are pregnant at Week 10 of gestation will be enrolled in NT-04.

Subjects in NT-04 will be contacted by telephone every 6 to 8 weeks until Week 38 of gestation, at which time subjects will be contacted every two weeks until confirmation of delivery. Information about pregnancy status and use of prescription medications will be collected at these telephone interviews.

Between Weeks 18 and 22 of gestation, an obstetrical ultrasound will be performed.

Following delivery, additional information will be obtained, including pregnancy outcome, gestational age at delivery, etc. Standardized photographs will be taken as part of a newborn assessment.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-07
• Primary Completion: 2015-08
• Status Verified: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-10
• Last Update Posted: 2015-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• At least one dose of study drug administered in NT-03
• Ongoing clinical pregnancy at Week 10 of gestation
• Able and willing to enroll in NT-04

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Follow-Up after dosing with Placebo	Post dosing with Placebo	Follow-Up after dosing with Placebo
Follow-Up after dosing with NT100 Dose 2	Post dosing with NT100	Follow-Up after dosing with NT100 Dose 2
Follow-Up after dosing with NT100 Dose 1	Post dosing with NT100	Follow-Up after dosing with NT100 Dose 1

Primary Outcome Measures

Name	Time	Method
Number of live births	Within approximately 7 months after NT-03

Secondary Outcome Measures

Name	Time	Method
Number of stillbirths	Within approximately 7 months after study NT-03
Number of congenital anomalies	Up to 4 weeks after birth
Number of severe neonatal adverse events	Up to 4 weeks after birth
Number of spontaneous abortions (miscarriages)	Within approximately 7 months after study NT-03