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

Study Overview
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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.

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

Conditions
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Repeated IVF Failure

Intervention / Treatment
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* Biological: Post dosing with NT100
* Other: Post dosing with Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Follow-Up after dosing with NT100 Dose 1<br>Follow-Up after dosing with NT100 Dose 1 | Biological: Post dosing with NT100<br> <br> |
| Experimental: Follow-Up after dosing with NT100 Dose 2<br>Follow-Up after dosing with NT100 Dose 2 | Biological: Post dosing with NT100<br> <br> |
| Placebo Comparator: Follow-Up after dosing with Placebo<br>Follow-Up after dosing with Placebo | Other: Post dosing with Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of live births |  | Within approximately 7 months after NT-03 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |