Expanding Fertility Care to Poor and Low Resourced Settings Study

Healthy Clinical Trial

— EXPLORE  

Official title:

Expanding Fertility Care to Poor and Low Resourced Settings Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05205733
• Other study ID #: 21-33495
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2022
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: University of California, San Francisco
• Contact: Alisha T Tolani, M.D.
• Phone: 415.353.7475
• Email: alisha.tolani[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This pilot study was designed to help providers identify barriers to completing the basic infertility work-up in a low resource setting with a focus on accessibility and feasibility of semen analysis testing. As a pilot study, a total of 60 male partners of patients who are seeking infertility treatment at the Zuckerberg San Francisco General Hospital Gynecology clinic will be recruited. Participants will be randomized to completing a semen analysis by either the standard in-clinic test or an at-home sperm testing kit. The investigators hypothesis is that there will be an increase in participants completing their semen analysis when using the at-home sperm testing kit as opposed to having to come to the lab.

Specific Aims:

1. To identify barriers to completing a semen analysis.

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

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

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

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

Patients seen at Zuckerberg San Francisco General who are currently undergoing an infertility evaluation as a part of the basic infertility assessment will be contacted. Consented participants will be randomized to complete an at home vs. lab semen analysis. After the semen analysis is completed, participants will be sent a comprehensive questionnaire regarding their experience, level of satisfaction, and barriers with completion of the recent semen analysis. Participants will be given 3 months to complete the semen analysis. If not completed in this timeframe, participants will be sent a different comprehensive questionnaire regarding their barriers with completion of the semen analysis. Additional clinical questions include time from semen analysis order to completion as well as time from semen analysis completion to start of treatment plan.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Fertility Disorders
• Healthy
• Infertility
• Infertility, Male
• Male Infertility

Intervention

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

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To identify barriers to completing a semen analysis.	The barriers will be identified via a survey to be completed by the participant.	Three months after being consented to the study.
Secondary	To compare barriers unique to completing an in-clinic versus at-home testing.	The unique barriers will be identified via a survey to be completed by the participant.	Three months after being consented to the study.
Secondary	To compare satisfaction scores with in-clinic versus at-home testing.	Patient satisfaction will be identified via a survey using the Likert Scale to be completed by the participant where strongly agree means very satisfied and strongly disagree is very unsatisfied.	Three months after being consented to the study.
Secondary	To compare the time to initiating treatment after completing in-clinic versus at-home testing.	The time to treatment initiation will be identified by the provider.	Six months after being consented to the study.