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

NCT ID: NCT01978561

Last Updated: 2015-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-09-30

Brief Summary

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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

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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

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Repeated IVF Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Follow-Up after dosing with NT100 Dose 1

Follow-Up after dosing with NT100 Dose 1

Group Type EXPERIMENTAL

Post dosing with NT100

Intervention Type BIOLOGICAL

Follow-Up after dosing with NT100 Dose 2

Follow-Up after dosing with NT100 Dose 2

Group Type EXPERIMENTAL

Post dosing with NT100

Intervention Type BIOLOGICAL

Follow-Up after dosing with Placebo

Follow-Up after dosing with Placebo

Group Type PLACEBO_COMPARATOR

Post dosing with Placebo

Intervention Type OTHER

Interventions

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Post dosing with NT100

Intervention Type BIOLOGICAL

Post dosing with Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nora Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Related Links

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http://www.thriveivf.com

Study NT-03, Thrive-IVF Research Study

Other Identifiers

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NT-04

Identifier Type: -

Identifier Source: org_study_id

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