A Multi-Center Study To Evaluate Multiple Doses of NT100 Following IVF In Women With Repeated IVF Failures (Thrive-IVF)

Completed · Phase 2 · Has a placebo group

Conditions studied: Repeated IVF Failure

In brief

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.

Key facts

Study ID

NCT01864356

Run by

Nora Therapeutics, Inc.

People needed

157

Starts

2013-05-01

Expected to finish

2014-09-01

Last updated by the study team

2014-11-20

Who can join

Age: 21 and older, up to 38. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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