Last updated: February 19, 2024
Sponsor: Inherent Biosciences
Overall Status: Active - Recruiting
Phase
N/A
Condition
Hypogonadism
Men's Health
Infertility
Treatment
N/AClinical Study ID
NCT05966883
SPOT001
Ages 18-45 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The subjects have been recommended to pursue IUI, or they have recently completed anIUI (regardless of outcome)
- Male partner is under 45 years of age
- Female partner is under 38 years of age
- The total motile sperm count from the raw semen analysis must be greater than or equalto 10 million
Exclusion
Exclusion Criteria:
- The female or male partner have a BMI equal to or greater than 40
- The male partner has undergone male testosterone replacement therapy in the last 6months
- Either the female or male partner have a history of recurrent pregnancy loss, definedas 2 or more consecutive clinical/ultrasound pregnancy losses
- There are any known factors contributing to female factor infertility, such as but notlimited to:
- Severe Endometriosis (stage 3 or higher, endometrioma on ovaries)
- Multiple uterine fibroids 5cm or larger
- Severe Asherman's Syndrome
- Severe Mullerian anomaly
- Lack of tubal patency in at least one fallopian tubes
Study Design
Total Participants: 1000
Study Start date:
January 01, 2023
Estimated Completion Date:
January 01, 2026
Study Description
Connect with a study center
Male Fertility and Sexual Medicine Specialists
San Diego, California 92120
United StatesActive - Recruiting
Shady Grove Fertility
Greenwood Village, Colorado 80111
United StatesActive - Recruiting
Yale Medicine
Orange, Connecticut 06477
United StatesActive - Recruiting
Boston IVF
Waltham, Massachusetts 02451
United StatesActive - Recruiting
Inception Fertility, LLC
Houston, Texas 77081
United StatesActive - Recruiting
University of Washington
Seattle, Washington 98105
United StatesActive - Recruiting
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