Infertility Assisted Reproductive TechnologyNCT07376109
Effects of Infertility and Assisted Reproductive Technology on Sexual Function and Behavior
An observational study of Infertility Assisted Reproductive Technology and Sexual Behavior, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Infertility Assisted Reproductive Technology, Sexual Behavior, Sexual Function
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 6 Feb 2026to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Assigned female at birth.
- Self-identify as a woman.
- Age 18-44 years.
- Diagnosis of infertility.
- Seeking fertility treatment at the MUHC Reproductive Centre.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
MUHC Reproductive Centre
Montreal, Quebec, H2L 4S8
Michael H Dahan, MD, (514) 843-1650, michael.dahan@mcgill.ca
About this study
Official title: Effect of Infertility and Assisted Reproductive Technology (ART) on Sexual Function and Behaviour
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.
Read more
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).
Read the 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.
Statistical analyses will include descriptive statistics to summarize participant characteristics, infertility variables, sexual function scores, and sexual behaviors. Comparisons between groups (e.g., primary vs. secondary infertility) will be performed using t-tests, and analyses across infertility duration categories will use analysis of variance (ANOVA). Pearson correlation coefficients will be used to examine relationships between the number of unsuccessful fertility treatment cycles and sexual function outcomes. Multivariable linear regression models will be constructed to evaluate the independent associations between infertility-related factors and sexual function while adjusting for relevant demographic variables. Missing data will be assessed for patterns and handled using appropriate statistical methods depending on the extent and nature of missingness.
Study data will be stored securely in accordance with institutional policies. Paper questionnaires are stored in locked cabinets, and electronic data are password-protected with restricted access. Data will be retained for five years following study completion and then securely destroyed. No future use of the data is planned.
- Conditions
- Infertility Assisted Reproductive Technology, Sexual Behavior, Sexual Function, Sexual Dysfunction and Infertility, Sexual Dysfunction Female, Infertility
- Keywords
- infertility, Assisted Reproductive Technology, ART, IVF, female sexual function, female sexual function index, FSFI, sexual behavior, sexual dysfunction, women's sexual health
- Medical subject headings
- Sexual Behavior, Sexual Dysfunction, Physiological, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start6 Feb 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility Assisted Reproductive TechnologyStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Dahan, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376109
- Sponsor's protocol ID
- MUHC-2025-11459
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Infertility and Assisted Reproductive Technology (ART) on Sexual Function and Behaviour
- ClinicalTrials.gov ID
- NCT07376109
- Acronym / sponsor ID
- MUHC-2025-11459
- Conditions
- Infertility Assisted Reproductive Technology, Sexual Behavior, Sexual Function, Sexual Dysfunction and Infertility, Sexual Dysfunction Female, Infertility
- Keywords
- infertility, Assisted Reproductive Technology, ART, IVF, female sexual function, female sexual function index, FSFI, sexual behavior
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Statistical analyses will include descriptive statistics to summarize participant characteristics, infertility variables, sexual function scores, and sexual behaviors. Comparisons between groups (e.g., primary vs. secondary infertility) will be performed using t-tests, and analyses across infertility duration categories will use analysis of variance (ANOVA). Pearson correlation coefficients will be used to examine relationships between the number of unsuccessful fertility treatment cycles and sexual function outcomes. Multivariable linear regression models will be constructed to evaluate the independent associations between infertility-related factors and sexual function while adjusting for relevant demographic variables. Missing data will be assessed for patterns and handled using appropriate statistical methods depending on the extent and nature of missingness.
Study data will be stored securely in accordance with institutional policies. Paper questionnaires are stored in locked cabinets, and electronic data are password-protected with restricted access. Data will be retained for five years following study completion and then securely destroyed. No future use of the data is planned.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- Assigned female at birth.
- Self-identify as a woman.
- Age 18-44 years.
- Diagnosis of infertility.
- Seeking fertility treatment at the MUHC Reproductive Centre.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility Assisted Reproductive Technology and Sexual Behavior, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca L Eckler, MD ((514) 843-1650, rebecca.eckler@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female sexual function (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.