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Other
I. for Infertility (FORT-T Trial)
N/A
Waitlist Available
Led By Richard H. Reindollar, M.D.
Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female partner age from 38th to the 43rd birthday at the time of recruitment and six months of infertility.
Male partner has a normal semen analysis showing at least 15 million total motile sperm/ejaculate and at least 1% normal forms by strict criteria, or at least 5 million total motile sperm in an IUI prep.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at end of study
Awards & highlights
FORT-T Trial Summary
This study will determine the most effective treatment strategy for infertile couples who present when the female partner is 38 years to the 43rd birthday and the couples are determined to have a reasonable chance for success.
FORT-T Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowFORT-T Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at end of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at end of study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Associated complications of treatment will be described.
Secondary outcome measures
Demographics and baseline variables will be collected, including: medical and reproductive, history, age, education, income, race, nutritional history, smoking history, and clinical variables related to infertility diagnosis and treatment.
FORT-T Trial Design
3Treatment groups
Active Control
Group I: I.Active Control2 Interventions
Those randomized to have clomiphene/IUI treatments first will initiate therapy with two cycles of the fertility pill called clomiphene combined with (IUI) intrauterine insemination. If not pregnant after 2 IUI cycles, the couples will then proceed to IVF.
Group II: II.Active Control2 Interventions
Those randomized to have gonadotropins/IUI treatments first will initiate therapy with two cycles of the fertility injections called FSH or gonadotropins combined with (IUI) intrauterine insemination. If not pregnant after 2 IUI cycles, the couples will then proceed to IVF.
Group III: III.Active Control1 Intervention
Those couples randomized to (IVF) in vitro fertilization will bypass IUI treatments and start IVF therapy immediately.
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,951 Previous Clinical Trials
2,660,336 Total Patients Enrolled
32 Trials studying Infertility
16,731 Patients Enrolled for Infertility
Richard H. Reindollar, M.D.Principal InvestigatorChair, Department of Obstetrics and Gynecology, Dartmouth-Hitchcock Medical Center, Dartmouth Medical School, Lebanon, New Hampshire
1 Previous Clinical Trials
503 Total Patients Enrolled
1 Trials studying Infertility
503 Patients Enrolled for Infertility
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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