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

NCT01864356 | Completed Phase 2 DMC

• 1 other identifier: NT-03
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 21

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.

Conditions

Repeated IVF Failure

Keywords

IVF failure; Repeated IVF failure; Implantation failure; Repeated implantation failure; IVF; NT100

Outcome Measures

Primary Outcomes (1)

• Ongoing clinical pregnancy rate

  The primary efficacy outcome measure is the ongoing clinical pregnancy rate at Week 8 of gestation.

  Week 8 of gestation

Secondary Outcomes (6)

• 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)

Study Arms (3)

NT100 Dose 1

EXPERIMENTAL

NT100 Dose 1

Drug: NT100

NT100 Dose 2

EXPERIMENTAL

NT100 Dose 2

Drug: NT100

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

NT100 DRUG

NT100 Dose 1; NT100 Dose 2

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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:
• ) 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
• ) At least two of the eligible IVF failures must have involved transfer of fresh embryos
• ) At least two of the eligible IVF failures must have involved retrieval of at least 5 oocytes
• ) 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)

Sponsors & Collaborators

• Nora Therapeutics, Inc.: lead

Study Sites (21)

HRC Fertility

Encino, California, 91436, United States

Location

HRC Fertility

Newport Beach, California, 92663, United States

Location

HRC Fertility

Pasadena, California, 91105, United States

Location

UCSF

San Francisco, California, United States

Location

Reproductive Associates of Delaware

Newark, Delaware, 19713, United States

Location

Columbia Fertility Associates

Washington D.C., District of Columbia, 20037, United States

Location

Florida Fertility Institute

Clearwater, Florida, 33759, United States

Location

IVF and Fertility Center of Miami

Miami, Florida, 33176, United States

Location

Georgia Reproductive Specialists

Atlanta, Georgia, 30342, United States

Location

Fertility Centers of Illinois / River North IVF Center

Chicago, Illinois, 60610, United States

Location

Fertility Centers of Illinois / Highland Park IVF Center

Highland Park, Illinois, 60035, United States

Location

Shady Grove Fertility

Rockville, Maryland, 20850, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Boston IVF

Waltham, Massachusetts, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Institute for Reproductive Health

Cincinnati, Ohio, 45209, United States

Location

Main Line Fertility Center

Bryn Mawr, Pennsylvania, 19010, United States

Location

Center for Assisted Reproduction

Bedford, Texas, 76022, United States

Location

Houston Fertility Institute

Houston, Texas, 77063, United States

Location

Center of Reproductive Medicine

Webster, Texas, 77598, United States

Location

Utah Fertility Center

Pleasant Grove, Utah, 84062, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 29, 2013
• Study Start: May 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 20, 2014

Record last verified: 2014-11

Locations

US (21)