A Multi-Center Study To Evaluate Multiple Doses of NT100 Following IVF In Women With Repeated IVF Failures (Thrive-IVF)
- Registration Number
- NCT01864356
- Lead Sponsor
- Nora Therapeutics, Inc.
- Brief Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of subcutaneous NT100 vs placebo following in vitro fertilization (IVF) in women with a history of repeated IVF failures.
- Detailed Description
NT-03 will be a randomized, double blind, multi-center, placebo controlled study of multiple doses of subcutaneous NT100 following IVF in women with a history of repeated IVF failures. Approximately 150 subjects will be randomized in a 1:1:1 ratio to receive subcutaneous NT100 low dose, NT100 high dose, or placebo, qd for up to 4 weeks.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 157
- Pre-menopausal female 21-38 years of age at screening
- 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
- Prior diagnosis of moderate or severe ovarian hyperstimulation syndrome (OHSS)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo NT100 Dose 1 NT100 NT100 Dose 1 NT100 Dose 2 NT100 NT100 Dose 2
- Primary Outcome Measures
Name Time Method Ongoing clinical pregnancy rate Week 8 of gestation The primary efficacy outcome measure is the ongoing clinical pregnancy rate at Week 8 of gestation.
- Secondary Outcome Measures
Name Time Method Biochemical evidence of pregnancy rate (as measured by hCG) Week 4 of gestation Ongoing clinical pregnancy rate Weeks 6 and 10 of gestation Implantation rate following embryo transfer Week 8 of gestation Number of subjects with adverse events and serious adverse events through 4 weeks after last dose of study drug (up to Week 10 of gestation) Changes in clinical laboratory parameters following study drug exposure through 4 weeks after the last dose of study drug (up to Week 10 of gestation) Moderate to severe ovarian hyperstimulation syndrome (OHSS) rate through Week 10 of gestation
Trial Locations
- Locations (19)
Shady Grove Fertility
๐บ๐ธRockville, Maryland, United States
HRC Fertility
๐บ๐ธPasadena, California, United States
Florida Fertility Institute
๐บ๐ธClearwater, Florida, United States
Columbia University
๐บ๐ธNew York, New York, United States
Fertility Centers of Illinois / River North IVF Center
๐บ๐ธChicago, Illinois, United States
Fertility Centers of Illinois / Highland Park IVF Center
๐บ๐ธHighland Park, Illinois, United States
Boston IVF
๐บ๐ธWaltham, Massachusetts, United States
Center of Reproductive Medicine
๐บ๐ธWebster, Texas, United States
Center for Assisted Reproduction
๐บ๐ธBedford, Texas, United States
Main Line Fertility Center
๐บ๐ธBryn Mawr, Pennsylvania, United States
Utah Fertility Center
๐บ๐ธPleasant Grove, Utah, United States
UCSF
๐บ๐ธSan Francisco, California, United States
IVF and Fertility Center of Miami
๐บ๐ธMiami, Florida, United States
Brigham and Women's Hospital
๐บ๐ธBoston, Massachusetts, United States
Institute for Reproductive Health
๐บ๐ธCincinnati, Ohio, United States
Houston Fertility Institute
๐บ๐ธHouston, Texas, United States
Columbia Fertility Associates
๐บ๐ธWashington, District of Columbia, United States
Reproductive Associates of Delaware
๐บ๐ธNewark, Delaware, United States
Georgia Reproductive Specialists
๐บ๐ธAtlanta, Georgia, United States