Expanding Fertility Care to Poor and Low Resourced Settings Study

NCT05205733 | Recruiting

• 1 other identifier: 21-33495
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators currently lack an understanding of barriers to completing the male factor infertility evaluation. Furthermore, as the investigators continue to expand access to fertility treatment particularly within low-resourced settings, it is important that all aspects of infertility within a couple are equally explored. The COVID-19 pandemic has disproportionately affected low-income communities and communities of color at greater rates in terms of not only disease morbidity/mortality but how medical systems are accessed and care is delivered.

Conditions

Healthy; Male Infertility; Infertility, Male; Fertility Disorders

Keywords

Disparities; Resource limited; Low-resource communities

Outcome Measures

Primary Outcomes (1)

• To compare the time to complete the semen analysis with in-clinic versus at-home testing.

  The time to completion between in-clinic versus at-home testing will be identified when the provider obtains the results.

  3 months after consented to the study.

Secondary Outcomes (4)

• To identify barriers to completing a semen analysis.

  Three months after being consented to the study.

• To compare barriers unique to completing an in-clinic versus at-home testing.

  Three months after being consented to the study.

• To compare satisfaction scores with in-clinic versus at-home testing.

  Three months after being consented to the study.

• To compare the time to initiating treatment after completing in-clinic versus at-home testing.

  Six months after being consented to the study.

Study Arms (2)

In-Clinic Semen Analysis Testing

NO INTERVENTION

Men needing semen analysis for infertility work-up.

No in-clinic semen analysis testing

EXPERIMENTAL

Men needing semen analysis for infertility work-up.

Other: Mail-in semen analysis kit

Interventions

Mail-in semen analysis kit OTHER

Presumably an easier, convenient, and more comfortable way to provide a semen analysis with an in-home mail-in semen analysis kit

Also known as: Fellow Health Semen Analysis

No in-clinic semen analysis testing

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All English or Spanish speaking male partners of female patients undergoing an infertility work-up evaluation at Zuckerberg San Francisco General Hospital and recommended to undergo a semen analysis as a part of this workup.

You may not qualify if:

• If they do not speak English or Spanish they will be excluded
• If they are under the age of 18 y.o
• If they are not recommended to undergo a semen analysis as a part of the infertility evaluation
• If they are unable to produce a semen sample.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94107, United States

RECRUITING

Related Publications (5)

• Bradshaw A, Ballon-Landa E, Owusu R, Hsieh TC. Poor Compliance With Postvasectomy Semen Testing: Analysis of Factors and Barriers. Urology. 2020 Feb;136:146-151. doi: 10.1016/j.urology.2019.10.026. Epub 2019 Nov 26.

  PMID: 31778681 BACKGROUND

• Practice Committee of the American Society for Reproductive Medicine. Diagnostic evaluation of the infertile male: a committee opinion. Fertil Steril. 2015 Mar;103(3):e18-25. doi: 10.1016/j.fertnstert.2014.12.103. Epub 2015 Jan 15.

  PMID: 25597249 BACKGROUND

• Infertility Workup for the Women's Health Specialist: ACOG Committee Opinion, Number 781. Obstet Gynecol. 2019 Jun;133(6):e377-e384. doi: 10.1097/AOG.0000000000003271.

  PMID: 31135764 BACKGROUND

• Ethics Committee of the American Society for Reproductive Medicine. Disparities in access to effective treatment for infertility in the United States: an Ethics Committee opinion. Fertil Steril. 2015 Nov;104(5):1104-10. doi: 10.1016/j.fertnstert.2015.07.1139. Epub 2015 Sep 10.

  PMID: 26364838 BACKGROUND

• Herndon CN, Anaya Y, Noel M, Cakmak H, Cedars MI. Outcomes from a university-based low-cost in vitro fertilization program providing access to care for a low-resource socioculturally diverse urban community. Fertil Steril. 2017 Oct;108(4):642-649.e4. doi: 10.1016/j.fertnstert.2017.06.035. Epub 2017 Sep 2.

  PMID: 28874259 BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Yanett Anaya, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alisha T Tolani, M.D.

CONTACT

415.353.7475; alisha.tolani@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to complete either a mail-in or in-clinic semen analysis.

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 25, 2022
• Study Start: May 24, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)