A Multi-Center Study To Evaluate Multiple Doses of NT100 Following IVF In Women With Repeated IVF… (NCT01864356) | Clinical Trial Compass
CompletedPhase 2
A Multi-Center Study To Evaluate Multiple Doses of NT100 Following IVF In Women With Repeated IVF Failures (Thrive-IVF)
United States157 participantsStarted 2013-05
Plain-language 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.
Who can participate
Age range
21 Years – 38 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.