RECRUITING

SpermQT Prospective Observational Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of the study is to validate the ability of the Epigenetic Sperm Quality Test (SpermQT) to assess a man's sperm quality and corresponding success of infertility treatments.

Official Title

SpermQT Prospective Observational Trial

Quick Facts

Study Start:2023-01-01

Study Completion:2026-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05966883

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* The subjects have been recommended to pursue IUI, or they have recently completed an IUI (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 equal to 10 million	* 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 6 months * Either the female or male partner have a history of recurrent pregnancy loss, defined as 2 or more consecutive clinical/ultrasound pregnancy losses * There are any known factors contributing to female factor infertility, such as but not limited 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

Inclusion Criteria

Exclusion Criteria

* The subjects have been recommended to pursue IUI, or they have recently completed an IUI (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 equal to 10 million

* 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 6 months
* Either the female or male partner have a history of recurrent pregnancy loss, defined as 2 or more consecutive clinical/ultrasound pregnancy losses
* There are any known factors contributing to female factor infertility, such as but not limited 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

Contacts and Locations

Study Contact

Kristin Brogaard, PhD

CONTACT

760-815-8706

kristin@inherentbio.com

Lorry Schneider, BS

CONTACT

808-286-6564

lorry@inherentbio.com

Principal Investigator

Kristin Brogaard, PhD

PRINCIPAL_INVESTIGATOR

Inherent Biosciences

Study Locations (Sites)

Male Fertility and Sexual Medicine Specialists

San Diego, California, 92120

United States

Shady Grove Fertility

Greenwood Village, Colorado, 80111

United States

Yale Medicine

Orange, Connecticut, 06477

United States

Boston IVF

Waltham, Massachusetts, 02451

United States

Inception Fertility, LLC

Houston, Texas, 77081

United States

University of Washington

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: Inherent Biosciences

Kristin Brogaard, PhD, PRINCIPAL_INVESTIGATOR, Inherent Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01

Study Completion Date2026-01-01

Study Record Updates

Study Start Date2023-01-01

Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

Epigenetics

Additional Relevant MeSH Terms

Male Infertility