Impact of Bariatric Surgery on Female Sexual Function and Sex Hormones

March 2, 2026 updated by: Ahmed Eid Ali Ahmed Aziz, Cairo University

Impact of Bariatric Surgery on Female Sexual Function, Sex Hormones, and Psychological Well-Being: A Prospective Cohort Study With Partner Assessment

The goal of this observational study is to learn about how weight loss surgery (also called bariatric surgery) affects sexual function and sex hormone levels in women with severe obesity. It will also look at how the surgery affects mood, quality of life, body image, and the partner's sexual health.

The main questions it aims to answer are:

  • Does sexual function improve after weight loss surgery?
  • Do sex hormone levels change after weight loss surgery?
  • Are these changes linked to improvements in mood and quality of life?
  • Does the partner also experience changes in sexual function?

Researchers will compare each participant's results before surgery to their results 6 months after surgery. This helps show how things change over time.

This study will include about 40 women who:

  • Are between 18 and 45 years old
  • Have severe obesity and are scheduled for weight loss surgery at Cairo University Hospital
  • Have a stable, sexually active partner relationship

What participants will do:

  • Complete questionnaires about sexual function, mood, quality of life, and body image (twice: before surgery and 6 months after)
  • Provide a blood sample to measure sex hormone levels (before surgery and 6 months after)
  • Their partners will complete a short questionnaire about their own sexual function

This research is important because sexual health is a key part of quality of life that is often overlooked in obesity care. Understanding how weight loss surgery affects sexual function, hormones, and mood can help doctors better counsel patients about what to expect after surgery. This is one of the first studies in Egypt to examine these questions and the first to include partner assessment.

The study will start in January 2026. Results will be available by late 2026.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

BACKGROUND:

Obesity is associated with significant physiological and psychological morbidity. While the metabolic effects of bariatric surgery are well-documented, its impact on female sexual health remains understudied, particularly in Middle Eastern populations. Sexual function is regulated by complex interactions between sex hormones (estrogen, testosterone, SHBG), psychological status (depression, anxiety), and body image. Obesity disrupts the hypothalamic-pituitary-gonadal axis through increased aromatase activity in adipose tissue, leading to hormonal imbalances. Weight loss following bariatric surgery may restore hormonal homeostasis and improve psychological well-being, potentially enhancing sexual function. However, the mediating pathways linking these changes have not been systematically examined.

OBJECTIVES:

Primary: To assess changes in female sexual function (FSFI scores) and sex hormone levels (total testosterone, free testosterone, estradiol E2, SHBG, and calculated Free Androgen Index) from baseline to 6 months after bariatric surgery.

Secondary: (1) To assess changes in depressive symptoms (Beck Depression Inventory-II) and anxiety symptoms (Beck Anxiety Inventory); (2) To assess changes in quality of life (Bariatric Quality of Life Index); (3) To assess body image satisfaction at 6 months; (4) To assess changes in partner sexual function (International Index of Erectile Function); (5) To explore mediating pathways linking weight loss, hormonal changes, mood improvement, and sexual function improvement;

METHODS:

Design: Prospective single-center observational cohort study. Setting: Department of General Surgery (Bariatric Surgery Unit), Kasr Al-Ainy Faculty of Medicine, Cairo University, Egypt.

Population: 40 morbidly obese female patients aged 18-45 years with stable, sexually active partner relationships, scheduled for primary bariatric surgery (sleeve gastrectomy or gastric bypass).

Procedures:

Eligible participants provide informed consent at baseline. Assessments occur at two time points: pre-operatively (within 2 weeks before surgery) and 6 months post-operatively.

At each assessment, participants undergo:

  1. Clinical evaluation: height, weight, BMI, smoking history, marital status, menstrual history (cycle regularity, last menstrual period), medication review

  2. Psychometric assessments:

    • Arabic Female Sexual Function Index (ArFSFI) - 19 items, 6 domains
    • Beck Depression Inventory-II (BDI-II) - 21 items
    • Beck Anxiety Inventory (BAI) - 21 items
    • Bariatric Quality of Life Index (BQL) - 30 items
    • Post-bariatric body image satisfaction questionnaire (6 months only)
  3. Hormonal assessment: Fasting morning blood sample (8:00-11:00 AM) during luteal phase for measurement of total testosterone, free testosterone, estradiol E2, and SHBG using electrochemiluminescence immunoassay. Free Androgen Index (FAI) is calculated as (total testosterone [nmol/L] × 100)/SHBG [nmol/L].
  4. Partner assessment: International Index of Erectile Function (IIEF) completed by partner

Significance:

This study will provide comprehensive, mechanistic insights into the multi-dimensional improvements in female sexual health following bariatric surgery. By including hormonal, psychological, and partner assessments, it addresses critical gaps in the literature and provides culturally-relevant data for Middle Eastern populations. Findings may inform pre-operative counseling and post-operative care for women undergoing bariatric surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Al-Manial Cairo
      • Cairo, Al-Manial Cairo, Egypt, 11956

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Morbidly obese female patients of childbearing age (18-50 years) with stable, sexually active intimate partner relationships, scheduled for primary bariatric surgery (sleeve gastrectomy or Roux-en-Y gastric bypass) at Cairo University Hospital, Egypt. Participants are recruited from the bariatric surgery clinic during routine pre-operative assessment.

Description

Inclusion Criteria:

  • Female gender
  • Age 18-45 years (childbearing period)
  • Body Mass Index (BMI) ≥40 kg/m² or ≥35 kg/m² with obesity-related comorbidities, meeting international criteria for bariatric surgery
  • Scheduled for primary bariatric surgery (sleeve gastrectomy or Roux-en-Y gastric bypass)
  • Presence of a stable, sexually active intimate partner relationship
  • Sexually active
  • Willingness to participate and provide informed consent
  • Ability to complete Arabic-language questionnaires

Exclusion Criteria:

  • Women who are not sexually active
  • Post-menopausal women (amenorrhea ≥12 months without other cause)
  • Current pregnancy or lactation
  • History of medication use that can interfere with sexual function, including:
  • Antidepressants
  • Antipsychotics/psychotropic drugs
  • Beta-blockers
  • Spironolactone
  • Hormonal contraceptives (unless stable for ≥3 months and continued throughout study)
  • Hormone replacement therapy
  • Major uncontrolled medical conditions:
  • Chronic heavy smoker (smoking index ≥400 pack-years)
  • History of pelvic floor surgery or gynecological malignancy
  • Partner with known erectile dysfunction or use of erectile dysfunction medications
  • Previous bariatric surgery (revisional procedures)
  • Inability or unwillingness to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Women Undergoing Bariatric Surgery
Morbidly obese female patients of childbearing age (18-50 years) with stable, sexually active intimate partner relationships, scheduled for primary bariatric surgery (sleeve gastrectomy or gastric bypass) at Cairo University Hospital. Participants are assessed at baseline (pre-operative) and at 6 months post-operatively for changes in sexual function, sex hormone levels, depression, anxiety, quality of life, and partner sexual function.
Procedure: Sleeve Gastrectomy
Laparoscopic sleeve gastrectomy involves resection of approximately 80% of the stomach, creating a tubular gastric pouch. This restrictive procedure reduces gastric capacity and alters gut hormones.
Procedure: Gastric Bypass
Laparoscopic gastric bypass creates a small gastric pouch (15-30 mL) that is anastomosed to the jejunum, bypassing the remainder of the stomach and proximal small intestine. This combined restrictive and malabsorptive procedure produces significant weight loss and metabolic improvements.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Female Sexual Function
Time Frame: Baseline and 6 months post-operative
Change in total score and domain scores of the Arabic Female Sexual Function Index (ArFSFI) from baseline to 6 months after bariatric surgery. The FSFI is a 19-item self-report questionnaire assessing sexual function over the past 4 weeks across six domains: desire (score range 1.2-6.0), arousal (0-6.0), lubrication (0-6.0), orgasm (0-6.0), satisfaction (0.8-6.0), and pain (0-6.0). Total score ranges from 2.0 to 36.0, with higher scores indicating better function. The Arabic version is validated in Egyptian populations. The cutoff for sexual dysfunction is ≤26.55.
Baseline and 6 months post-operative
Change in Sex Hormone Levels
Time Frame: Baseline and 6 months post-operative
Change in serum levels of reproductive hormones from baseline to 6 months after bariatric surgery. Measured parameters: (1) Total Testosterone (ng/dL), (2) Free Testosterone (pg/mL), (3) Estradiol E2 (pg/mL), (4) Sex Hormone Binding Globulin (SHBG) (nmol/L), and (5) calculated Free Androgen Index (FAI). FAI = (Total Testosterone [nmol/L] × 100) / SHBG [nmol/L]. Samples collected fasting between 8:00-11:00 AM during luteal phase. Measured by electrochemiluminescence immunoassay.
Baseline and 6 months post-operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Depressive Symptoms
Time Frame: Baseline and 6 months post-operative
Change in Beck Depression Inventory-II (BDI-II) scores from baseline to 6 months after bariatric surgery. The BDI-II is a 21-item self-report inventory measuring depression severity over the past two weeks. Each item scored 0-3, total scores 0-63. Higher scores indicate more severe depression. Cutoffs: 0-13 minimal, 14-19 mild, 20-28 moderate, 29-63 severe. Arabic validated version used.
Baseline and 6 months post-operative
Change in Anxiety Symptoms
Time Frame: Baseline and 6 months post-operative
Change in Beck Anxiety Inventory (BAI) scores from baseline to 6 months after bariatric surgery. The BAI is a 21-item self-report questionnaire measuring anxiety severity with focus on somatic symptoms. Each item scored 0-3, total scores 0-63. Higher scores indicate more severe anxiety. Cutoffs: 0-7 minimal, 8-15 mild, 16-25 moderate, 26-63 severe. Arabic validated version used.
Baseline and 6 months post-operative
Change in Quality of Life
Time Frame: Baseline and 6 months post-operative
Change in Bariatric Quality of Life (BQL) Index scores from baseline to 6 months after bariatric surgery. The BQL Index is a 30-item validated instrument with two sections: Section 1 (16 items) assesses non-QoL factors (comorbidities, symptoms, medications); Section 2 (14 items) assesses QoL factors on 5-point Likert scale. Total scores range 14-78, with higher scores indicating better quality of life.
Baseline and 6 months post-operative
Body Image Satisfaction
Time Frame: Baseline and 6 months post-operative
Assessment of body image satisfaction at 6 months after bariatric surgery using the Post-bariatric Body Image Satisfaction Questionnaire. This instrument measures satisfaction with appearance after weight loss on a 5-point Likert scale from "strongly satisfied" to "strongly dissatisfied."
Baseline and 6 months post-operative
Change in Partner Sexual Function
Time Frame: Baseline and 6 months post-operative
Change in International Index of Erectile Function (IIEF) scores from baseline to 6 months after the participant's bariatric surgery. The IIEF is a 15-item questionnaire assessing male sexual function across five domains: erectile function (score 1-30), orgasmic function (0-10), sexual desire (2-10), intercourse satisfaction (0-15), and overall satisfaction (2-10). Total scores range 5-75, higher scores indicate better function. Completed by participant's stable partner. Arabic validated version used.
Baseline and 6 months post-operative
Correlation Between Mood Improvement and Sexual Function Improvement
Time Frame: Baseline to 6 months post-operative
Pearson or Spearman correlation coefficients examining the relationship between change in Beck Depression Inventory-II score (ΔBDI-II), Beck Anxiety Inventory (BAI) and change in Female Sexual Function Index total score (ΔFSFI) from baseline to 6 months post-operative. This analysis tests whether psychological improvement mediates improvements in sexual function.
Baseline to 6 months post-operative
Correlation Between Hormonal Changes and Sexual Function Improvement
Time Frame: Baseline to 6 months post-operative
Pearson or Spearman correlation coefficients examining the relationship between change in Free Androgen Index (ΔFAI) and change in Female Sexual Function Index total score (ΔFSFI) from baseline to 6 months post-operative. This analysis tests whether hormonal normalization mediates improvements in sexual function.
Baseline to 6 months post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CU-BS-WSF-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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