Completed

Thrive-IVFA 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)

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What is being tested

NT100

+ Placebo

Drug
Who is being recruted

From 21 to 38 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorNora Therapeutics, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

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.

Official TitleA 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)
Principal SponsorNora Therapeutics, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

157 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 21 to 38 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

11 inclusion criteria required to participate
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

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8 exclusion criteria prevent from participating
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

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
NT100 Dose 1

Group II

Experimental
NT100 Dose 2

Group III

Placebo
Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 21 locations

Suspended

HRC Fertility

Encino, United StatesOpen HRC Fertility in Google Maps
Suspended

HRC Fertility

Newport Beach, United States
Suspended

HRC Fertility

Pasadena, United States
Suspended

UCSF

San Francisco, United States
Completed21 Study Centers