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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01978561

Acronym

Thrive-IVF F/U

Enrollment

Registered

2013-11-07

Start date

2013-10-31

Completion date

2015-09-30

Last updated

2015-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Repeated IVF Failure

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.

Interventions

BIOLOGICALPost dosing with NT100

OTHERPost dosing with Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 39 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026