Follow-Up Of Pregnancies Established During Study NT-03 (Thrive-IVF Follow-Up)
NCT ID: NCT01978561
Last Updated: 2015-09-14
Study Results
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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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2013-10-31
2015-09-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Follow-Up after dosing with NT100 Dose 1
Follow-Up after dosing with NT100 Dose 1
Post dosing with NT100
Follow-Up after dosing with NT100 Dose 2
Follow-Up after dosing with NT100 Dose 2
Post dosing with NT100
Follow-Up after dosing with Placebo
Follow-Up after dosing with Placebo
Post dosing with Placebo
Interventions
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Post dosing with NT100
Post dosing with Placebo
Eligibility Criteria
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Inclusion Criteria
* Ongoing clinical pregnancy at Week 10 of gestation
* Able and willing to enroll in NT-04
Exclusion Criteria
21 Years
39 Years
FEMALE
No
Sponsors
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Nora Therapeutics, Inc.
INDUSTRY
Responsible Party
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Related Links
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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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