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Morbid ObesityNCT07446972

Impact of Bariatric Surgery on Female Sexual Function and Sex Hormones

An observational study of Morbid Obesity, run by Cairo University at 1 site in Egypt.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Morbid Obesity
What is being tested?
Sleeve Gastrectomy and Gastric Bypass
Type of treatment
Surgery or procedure
How many people
40 participants
Where
1 siteEgypt
Study dates
5 Jun 2026to Feb 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 45 years
  • Women only
  • No healthy volunteers
  • Adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ahmed Eid Aziz, Lecturer contact

+201127060844

Ahmed-eid@kasralainy.edu.eg

Egypt1 site, 1 recruiting
  • Faculty of Medicine Cairo University

    Cairo, Al-Manial Cairo, 11956

    Mahmoud El Azhary, Lecturer, +201064110221, Mahmoud.azhary@kasralainy.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: 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:

Read more
  • 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.

Read the 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)
  1. 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].
  2. 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.

Conditions
Morbid Obesity
Being tested
Sleeve Gastrectomy, Gastric Bypass
Keywords
Bariatric Surgery, Female Sexual Function Index, Sex Hormones, Beck Depression Inventory, Beck Anxiety Inventory, Quality of Life, Body Image, Partner Assessment
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleeve GastrectomyProcedure or surgery

    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.

  • Gastric BypassProcedure or surgery

    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.

Study groups in NCT07446972
Study groupRoleWhat they receive
Women Undergoing Bariatric SurgeryMorbidly 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.
Receives: Procedure: Sleeve Gastrectomy; Procedure: Gastric Bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Female Sexual Function

    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.

    Measured: Baseline and 6 months post-operative

  2. Change in Sex Hormone Levels

    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.

    Measured: Baseline and 6 months post-operative

Secondary outcomes (7)
  1. Change in Depressive Symptoms

    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.

    Measured: Baseline and 6 months post-operative

  2. Change in Anxiety Symptoms

    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.

    Measured: Baseline and 6 months post-operative

  3. Change in Quality of Life

    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.

    Measured: Baseline and 6 months post-operative

  4. Body Image Satisfaction

    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."

    Measured: Baseline and 6 months post-operative

  5. Change in Partner Sexual Function

    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.

    Measured: Baseline and 6 months post-operative

  6. Correlation Between Mood Improvement and Sexual Function Improvement

    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.

    Measured: Baseline to 6 months post-operative

  7. Correlation Between Hormonal Changes and Sexual Function Improvement

    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.

    Measured: Baseline to 6 months post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2026
  2. Study start5 Jun 2026
  3. Primary completionDec 2026 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07446972
Sponsor's protocol ID
MS-58-2026
Status last verified
Mar 2026
First submitted
26 Feb 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Morbid Obesity, run by Cairo University at 1 site in Egypt.

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 8 inclusion and 16 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 10 Jun 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 Egypt. 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 Ahmed Eid Aziz, Lecturer (+201127060844, Ahmed-eid@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Female Sexual Function (time frame: Baseline and 6 months post-operative). 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 10 Jun 2026.

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