Clinical trial NCT01864356: A Multi-Center Study To Evaluate Multiple Doses of NT100 Following IVF In Women With Repeated IVF Failures (Thrive-IVF)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Repeated IVF Failure
Keywords: IVF failure
Repeated IVF failure
Implantation failure
Repeated implantation failure
IVF
NT100
Lead sponsor: Nora Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 157
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Ongoing clinical pregnancy rate
timeFrame: Week 8 of gestation
Secondary outcomes:
measure: Biochemical evidence of pregnancy rate (as measured by hCG)
timeFrame: Week 4 of gestation
measure: Ongoing clinical pregnancy rate
timeFrame: Weeks 6 and 10 of gestation
measure: Implantation rate following embryo transfer
timeFrame: Week 8 of gestation
measure: Number of subjects with adverse events and serious adverse events
timeFrame: through 4 weeks after last dose of study drug (up to Week 10 of gestation)
measure: Changes in clinical laboratory parameters following study drug exposure
timeFrame: through 4 weeks after the last dose of study drug (up to Week 10 of gestation)
measure: Moderate to severe ovarian hyperstimulation syndrome (OHSS) rate
timeFrame: through Week 10 of gestation
Other outcomes:
Locations:
city: Encino
country: United States
facility: HRC Fertility
state: California
city: Newport Beach
country: United States
facility: HRC Fertility
state: California
city: Pasadena
country: United States
facility: HRC Fertility
state: California
city: San Francisco
country: United States
facility: UCSF
state: California
city: Newark
country: United States
facility: Reproductive Associates of Delaware
state: Delaware
city: Washington
country: United States
facility: Columbia Fertility Associates
state: District of Columbia
city: Clearwater
country: United States
facility: Florida Fertility Institute
state: Florida
city: Miami
country: United States
facility: IVF and Fertility Center of Miami
state: Florida
city: Atlanta
country: United States
facility: Georgia Reproductive Specialists
state: Georgia
city: Chicago
country: United States
facility: Fertility Centers of Illinois / River North IVF Center
state: Illinois
city: Highland Park
country: United States
facility: Fertility Centers of Illinois / Highland Park IVF Center
state: Illinois
city: Rockville
country: United States
facility: Shady Grove Fertility
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Waltham
country: United States
facility: Boston IVF
state: Massachusetts
city: New York
country: United States
facility: Columbia University
state: New York
city: Cincinnati
country: United States
facility: Institute for Reproductive Health
state: Ohio
city: Bryn Mawr
country: United States
facility: Main Line Fertility Center
state: Pennsylvania
city: Bedford
country: United States
facility: Center for Assisted Reproduction
state: Texas
city: Houston
country: United States
facility: Houston Fertility Institute
state: Texas
city: Webster
country: United States
facility: Center of Reproductive Medicine
state: Texas
city: Pleasant Grove
country: United States
facility: Utah Fertility Center
state: Utah
Study officials:
References: