A Phase 2 interventional study of Post dosing with NT100 and Post dosing with Placebo in Repeated IVF Failure, sponsored by Nora Therapeutics, Inc.. Completed. Open to female participants aged 21 Years to 39 Years. Per ClinicalTrials.gov, last updated 2015-09-14.
Sponsored by Nora Therapeutics, Inc. · Phase 2 and Interventional
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.
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.
Nora Therapeutics, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Follow-Up after dosing with NT100 Dose 1
Biological: Post dosing with NT100
Follow-Up after dosing with NT100 Dose 2
Biological: Post dosing with NT100
Follow-Up after dosing with Placebo
Other: Post dosing with Placebo
Number of live births
Time frame: Within approximately 7 months after NT-03
Number of stillbirths
Time frame: Within approximately 7 months after study NT-03
Number of spontaneous abortions (miscarriages)
Time frame: Within approximately 7 months after study NT-03
Number of congenital anomalies
Time frame: Up to 4 weeks after birth
Number of severe neonatal adverse events
Time frame: Up to 4 weeks after birth
No study locations are listed for this record.
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Nora Therapeutics, Inc.