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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
157
HRC Fertility
Encino, California, United States
Ongoing clinical pregnancy rate
The primary efficacy outcome measure is the ongoing clinical pregnancy rate at Week 8 of gestation.
Time frame: Week 8 of gestation
Biochemical evidence of pregnancy rate (as measured by hCG)
Time frame: Week 4 of gestation
Ongoing clinical pregnancy rate
Time frame: Weeks 6 and 10 of gestation
Implantation rate following embryo transfer
Time frame: Week 8 of gestation
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)
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)
Moderate to severe ovarian hyperstimulation syndrome (OHSS) rate
Time frame: through Week 10 of gestation
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