NCT01978561

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Nora Therapeutics, Inc. · Industry
• Sex: Female
• Age: 21 Years – 39 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Repeated IVF Failure

Interventions

Type	Name	Description
BIOLOGICAL	Post dosing with NT100
OTHER	Post dosing with Placebo

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2013-11-07
• Last updated: 2015-09-14