Status:
COMPLETED
A Multi-Center Study To Evaluate Multiple Doses of NT100 Following IVF In Women With Repeated IVF Failures (Thrive-IVF)
Lead Sponsor:
Nora Therapeutics, Inc.
Conditions:
Repeated IVF Failure
Eligibility:
FEMALE
21-38 years
Phase:
PHASE2
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 repe...
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 1...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT01864356
Start Date
May 1 2013
End Date
September 1 2014
Last Update
November 20 2014
Active Locations (21)
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1
HRC Fertility
Encino, California, United States, 91436
2
HRC Fertility
Newport Beach, California, United States, 92663
3
HRC Fertility
Pasadena, California, United States, 91105
4
UCSF
San Francisco, California, United States