NCT07376109

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Feb 2026Jan 2027

First Submitted

Initial submission to the registry

January 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

February 6, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

January 22, 2026

Last Update Submit

February 19, 2026

Conditions

Keywords

infertilityAssisted Reproductive TechnologyARTIVFfemale sexual functionfemale sexual function indexFSFIsexual behaviorsexual dysfunctionwomen's sexual health

Outcome Measures

Primary Outcomes (2)

  • Female sexual function

    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.

    Day 1

  • Sexual Behaviour

    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.

    Day 1

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll individuals who self-identify as women and were assigned female at birth are eligible to participate. Individuals assigned male at birth or who do not self-identify as women are excluded.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study will include women assigned female at birth, aged 18-44 years, who are seeking fertility treatment at the MUHC Reproductive Centre and have a diagnosis of infertility. Participants must self-identify as women. Individuals assigned male at birth, age 45 or older, seeking oocyte cryopreservation, or whose sexual practices do not allow for conception without assisted reproductive technologies will be excluded. Participation is voluntary and anonymous.

You may qualify if:

  • Assigned female at birth.
  • Self-identify as a woman.
  • Age 18-44 years.
  • Diagnosis of infertility.
  • Seeking fertility treatment at the MUHC Reproductive Centre.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUHC Reproductive Centre

Montreal, Quebec, H2L 4S8, Canada

RECRUITING

MeSH Terms

Conditions

Sexual BehaviorSexual Dysfunction, PhysiologicalInfertility

Condition Hierarchy (Ancestors)

BehaviorGenital DiseasesUrogenital Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Obstetrics and Gynecology; Reproductive Endocrinology and Infertility

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 29, 2026

Study Start

February 6, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because all data are collected anonymously using paper questionnaires, contain no personal identifiers, and participants did not provide consent for data sharing beyond the scope of this study.

Locations