Effect of Infertility and Assisted Reproductive Technology (ART) on Sexual Function and Behaviour
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Female sexual function
Study Overview
Brief Summary
This cross-sectional observational study examines how infertility and the use of assisted reproductive technology (ART) are related to sexual function and sexual behaviors in women seeking fertility treatment. Infertility and the stress of ART may be associated with changes in sexual desire, satisfaction, and activity. The purpose is to better understand these associations to support the sexual health and overall well-being of women undergoing fertility care.
Women who are assigned female at birth, under 45 years old, diagnosed with infertility, and attending appointments at the MUHC Reproductive Centre are invited to take part. Participants will be asked to complete an anonymous questionnaire while waiting for their clinical visit. The questionnaire includes the validated Female Sexual Function Index (FSFI), which measures different aspects of sexual function, and additional questions about sexual activities, such as frequency of intercourse and other behaviors before and after fertility treatments.
Participants will not provide any identifying information. Completed questionnaires will be placed in a secure collection box to protect confidentiality.
Data from approximately 500 participants will be analyzed to explore how infertility type (primary vs. secondary), duration of infertility, and the number of unsuccessful ART cycles relate to sexual function and behavior. Findings from this study may help healthcare providers better recognize and address the sexual health concerns of women with infertility.
This study is approved by the McGill University Health Centre Research Ethics Board (REB #2025-11459).
Detailed Description
This is a single-center, cross-sectional observational study conducted at the McGill University Health Centre (MUHC) Reproductive Centre. The study is designed to examine associations between infertility characteristics and sexual function and sexual behaviors among women undergoing fertility treatment.
Participants are recruited in person during routine clinic visits. Anonymous, paper-based questionnaires are distributed by a research assistants. Questionnaires are completed voluntarily while participants are waiting for their appointment and returned anonymously into a secure collection box. No identifying information is collected at any time, and responses are not linked to medical records.
Sexual function is assessed using the validated Female Sexual Function Index (FSFI), which evaluates multiple domains of sexual function, including desire, arousal, lubrication, orgasm, satisfaction, and pain. Additional survey items assess sexual behaviors and changes in sexual activity patterns in the context of infertility and fertility treatment. Infertility-related variables include duration of infertility, type of infertility (primary vs. secondary), and history of fertility treatments, including unsuccessful treatment cycles.
Data from completed questionnaires are entered into a secure electronic database. Surveys that do not meet inclusion criteria based on self-reported responses are excluded from analysis.
The planned sample size is approximately 500 participants, based on clinic volume and feasibility over a 12-month recruitment period. This sample size is expected to provide sufficient power to detect clinically meaningful differences in sexual function scores across infertility subgroups.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 44 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Assigned female at birth.
- •Self-identify as a woman.
- •Age 18-44 years.
- •Diagnosis of infertility.
- •Seeking fertility treatment at the MUHC Reproductive Centre.
Exclusion Criteria
- •Assigned male at birth.
- •Age 45 years or older.
- •Sexual practices that do not allow for the possibility of conception (e.g., same-sex relationships without use of assisted reproductive technologies).
- •Seeking oocyte cryopreservation.
- •Individuals who do not wish to complete the anonymous questionnaire.
Arms & Interventions
Observational Infertility Cohort
Women attending the MUHC Reproductive Centre for evaluation or treatment of infertility who complete a single anonymous questionnaire assessing sexual function and sexual behaviour.
Outcomes
Primary Outcomes
Female sexual function
Time Frame: Day 1
Female sexual function as assessed using the validated Female Sexual Function Index (FSFI), which evaluates desire, arousal, lubrication, orgasm, satisfaction, and pain. Higher scores indicate better sexual function.
Sexual Behaviour
Time Frame: Day 1
Self-reported sexual behaviors, including intercourse frequency (pre- and post-fertility treatment), oral sex, anal sex, masturbation, and other sexual practices, as assessed by the anonymous questionnaire.
Secondary Outcomes
No secondary outcomes reported
Investigators
Michael Dahan
Assistant Professor, Department of Obstetrics and Gynecology; Reproductive Endocrinology and Infertility
McGill University Health Centre/Research Institute of the McGill University Health Centre