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

Pregnancy, Delivery, And Neonatal Outcomes In Subjects With Ongoing Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)

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.

Study Overview

• Status: Completed
• Conditions: Repeated IVF Failure
• Intervention / Treatment: Biological: Post dosing with NT100; Other: Post dosing with Placebo

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Follow-Up after dosing with NT100 Dose 1	Biological: Post dosing with NT100
Experimental: Follow-Up after dosing with NT100 Dose 2	Biological: Post dosing with NT100
Placebo Comparator: Follow-Up after dosing with Placebo	Other: Post dosing with Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of live births	Within approximately 7 months after NT-03

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of stillbirths	Within approximately 7 months after study NT-03
Number of spontaneous abortions (miscarriages)	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

Collaborators and Investigators

• Sponsor: Nora Therapeutics, Inc.

Publications and helpful links

Helpful Links

• Study NT-03, Thrive-IVF Research Study

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: November 1, 2013
• First Submitted That Met QC Criteria: November 1, 2013
• First Posted (Estimate): November 7, 2013

Study Record Updates

• Last Update Posted (Estimate): September 14, 2015
• Last Update Submitted That Met QC Criteria: September 10, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: NT-04