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

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ClinicalTrials.gov Identifier: NCT01864356
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : November 20, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Repeated IVF Failure Drug: NT100 Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : May 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: NT100 Dose 1
NT100 Dose 1
Drug: NT100
Experimental: NT100 Dose 2
NT100 Dose 2
Drug: NT100
Placebo Comparator: Placebo
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. Ongoing clinical pregnancy rate [ Time Frame: Week 8 of gestation ]
    The primary efficacy outcome measure is the ongoing clinical pregnancy rate at Week 8 of gestation.


Secondary Outcome Measures :
  1. Biochemical evidence of pregnancy rate (as measured by hCG) [ Time Frame: Week 4 of gestation ]
  2. Ongoing clinical pregnancy rate [ Time Frame: Weeks 6 and 10 of gestation ]
  3. Implantation rate following embryo transfer [ Time Frame: Week 8 of gestation ]
  4. Number of subjects with adverse events and serious adverse events [ Time Frame: through 4 weeks after last dose of study drug (up to Week 10 of gestation) ]
  5. Changes in clinical laboratory parameters following study drug exposure [ Time Frame: through 4 weeks after the last dose of study drug (up to Week 10 of gestation) ]
  6. Moderate to severe ovarian hyperstimulation syndrome (OHSS) rate [ Time Frame: through Week 10 of gestation ]


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Ages Eligible for Study:   21 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864356


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

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Responsible Party: Nora Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01864356     History of Changes
Other Study ID Numbers: NT-03
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014
Keywords provided by Nora Therapeutics, Inc.:
IVF failure
Repeated IVF failure
Implantation failure
Repeated implantation failure
IVF
NT100