A Multi-Center Study To Evaluate Multiple Doses of NT100 Following IVF In Women With Repeated IVF Failures (Thrive-IVF)
NCT ID: NCT01864356
Last Updated: 2014-11-20
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
157 participants
INTERVENTIONAL
2013-05-31
2014-09-30
Brief Summary
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Detailed Description
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Screening will include a standard IVF stimulation protocol, followed by fertilization and culture of embryos. If the subject remains eligible, she will be randomized to receive study drug. All subjects will be followed for 4 weeks after the last dose of study drug. At Week 10 of gestation, subjects who are pregnant will roll over into a follow-up study (NT-04) to assess subsequent pregnancy, delivery, and neonatal outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NT100 Dose 1
NT100 Dose 1
NT100
NT100 Dose 2
NT100 Dose 2
NT100
Placebo
Placebo
Placebo
Interventions
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NT100
Placebo
Eligibility Criteria
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Inclusion Criteria
* History of repeated IVF failures despite transfer of good-quality embryos, defined as follows:
* ...1) 3 or more IVF cycles involving transfer of at least two good-quality cleavage-stage embryos or at least one good-quality blastocyst (2010 SART (Society for Assisted Reproductive Technologies) grading criteria)that resulted in one of the following outcomes:
* \* .....a) no pregnancy
* \* .....b) biochemical pregnancy
* \* .....c) spontaneous abortion of an intrauterine clinical pregnancy before or equal to completed Week 8 of gestation
* ...2) At least two of the eligible IVF failures must have involved transfer of fresh embryos
* ...3) At least two of the eligible IVF failures must have involved retrieval of at least 5 oocytes
* ...4) No live birth, abortion later than Week 8 of gestation, or stillbirth may have occurred since the first of these IVF failures
* Body mass index (BMI) of 19-38 kg per m2 at screening
* TSH (thyroid-stimulating hormone) less than or equal to 4.0 mIU/L(milli-International units per Liter) for subjects with no history of hypothyroidism, or TSH less than or equal to 2.5 mIU/L for subjects with a history of hypothyroidism, at screening
Exclusion Criteria
* Clinically confirmed polycystic ovary syndrome (PCOS)
* History of a major congenital anomaly in the subject, her current male partner, or first degree relative of either the subject or her current male partner
* Known karyotype abnormalities in either the subject or her current male partner / sperm donor
* Any prior pregnancy terminated for a fetal medical condition
* History of severe (stage IV) endometriosis
* Current or past systemic autoimmune disease
* Any uncontrolled clinically significant medical condition (e.g. asthma, Type II diabetes, infection)
21 Years
38 Years
FEMALE
No
Sponsors
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Nora Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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HRC Fertility
Encino, California, United States
HRC Fertility
Newport Beach, California, United States
HRC Fertility
Pasadena, California, United States
UCSF
San Francisco, California, United States
Reproductive Associates of Delaware
Newark, Delaware, United States
Columbia Fertility Associates
Washington D.C., District of Columbia, United States
Florida Fertility Institute
Clearwater, Florida, United States
IVF and Fertility Center of Miami
Miami, Florida, United States
Georgia Reproductive Specialists
Atlanta, Georgia, United States
Fertility Centers of Illinois / River North IVF Center
Chicago, Illinois, United States
Fertility Centers of Illinois / Highland Park IVF Center
Highland Park, Illinois, United States
Shady Grove Fertility
Rockville, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston IVF
Waltham, Massachusetts, United States
Columbia University
New York, New York, United States
Institute for Reproductive Health
Cincinnati, Ohio, United States
Main Line Fertility Center
Bryn Mawr, Pennsylvania, United States
Center for Assisted Reproduction
Bedford, Texas, United States
Houston Fertility Institute
Houston, Texas, United States
Center of Reproductive Medicine
Webster, Texas, United States
Utah Fertility Center
Pleasant Grove, Utah, United States
Countries
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Other Identifiers
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NT-03
Identifier Type: -
Identifier Source: org_study_id