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

A Randomized, Double Blind, Multi-Center, Placebo Controlled Study To Evaluate The Efficacy, Safety, And Tolerability Of Multiple Doses Of NT100 Following IVF In Women With A History Of Repeated IVF Failures (Thrive-IVF)

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.

Study Overview

• Status: Completed
• Conditions: Repeated IVF Failure
• Intervention / Treatment: Drug: Placebo; Drug: NT100

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.

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91436
      • HRC Fertility
    • Newport Beach, California, United States, 92663
      • HRC Fertility
    • Pasadena, California, United States, 91105
      • HRC Fertility
    • San Francisco, California, United States
      • UCSF
  • Delaware
    • Newark, Delaware, United States, 19713
      • Reproductive Associates of Delaware
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Columbia Fertility Associates
  • Florida
    • Clearwater, Florida, United States, 33759
      • Florida Fertility Institute
    • Miami, Florida, United States, 33176
      • IVF and Fertility Center of Miami
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Georgia Reproductive Specialists
  • Illinois
    • Chicago, Illinois, United States, 60610
      • Fertility Centers of Illinois / River North IVF Center
    • Highland Park, Illinois, United States, 60035
      • Fertility Centers of Illinois / Highland Park IVF Center
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Shady Grove Fertility
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Waltham, Massachusetts, United States
      • Boston IVF
  • New York
    • New York, New York, United States, 10032
      • Columbia University
  • Ohio
    • Cincinnati, Ohio, United States, 45209
      • Institute for Reproductive Health
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Main Line Fertility Center
  • Texas
    • Bedford, Texas, United States, 76022
      • Center for Assisted Reproduction
    • Houston, Texas, United States, 77063
      • Houston Fertility Institute
    • Webster, Texas, United States, 77598
      • Center of Reproductive Medicine
  • Utah
    • Pleasant Grove, Utah, United States, 84062
      • Utah Fertility Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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 Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: NT100 Dose 1	Drug: NT100
Experimental: NT100 Dose 2	Drug: NT100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Nora Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 24, 2013
• First Posted (Estimate): May 29, 2013

Study Record Updates

• Last Update Posted (Estimate): November 20, 2014
• Last Update Submitted That Met QC Criteria: November 18, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: IVF; Implantation failure; IVF failure; Repeated implantation failure; Repeated IVF failure; NT100
• Other Study ID Numbers: NT-03