Skip to main content
OpenTrials
Completed

NCT Number: NCT01978561

Follow-Up Of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Repeated IVF Failure

Age range

21 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Post dosing with NT100

Biological

Post dosing with Placebo

Other

Primary outcomes

  1. Number of live births

    Time frame: Within approximately 7 months after NT-03

Secondary outcomes

  1. Number of stillbirths

    Time frame: Within approximately 7 months after study NT-03

  2. Number of spontaneous abortions (miscarriages)

    Time frame: Within approximately 7 months after study NT-03

  3. Number of congenital anomalies

    Time frame: Up to 4 weeks after birth

  4. Number of severe neonatal adverse events

    Time frame: Up to 4 weeks after birth

Sponsors and collaborators

Lead sponsor

Nora Therapeutics, Inc.

Industry

Registry information

Official study title

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

Acronym: Thrive-IVF F/U

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 7, 2013
Registry last updated
Sep 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.