Impact of Bariatric Surgery on Female Sexual Function and Sex Hormones

NCT07446972 | Not Yet Recruiting

• 1 other identifier: CU-BS-WSF-2026
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Morbid Obesity

Keywords

Bariatric Surgery; Female Sexual Function Index; Sex Hormones; Beck Depression Inventory; Beck Anxiety Inventory; Quality of Life; Body Image; Partner Assessment

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 6 months post-operative

• 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.

  Baseline and 6 months post-operative

Secondary Outcomes (7)

• Change in Depressive Symptoms

  Baseline and 6 months post-operative

• Change in Anxiety Symptoms

  Baseline and 6 months post-operative

• Change in Quality of Life

  Baseline and 6 months post-operative

• Body Image Satisfaction

  Baseline and 6 months post-operative

• Change in Partner Sexual Function

  Baseline and 6 months post-operative

Study Arms (1)

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; Procedure: Gastric Bypass

Interventions

Sleeve Gastrectomy PROCEDURE

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.

Women Undergoing Bariatric Surgery

Gastric Bypass PROCEDURE

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.

Women Undergoing Bariatric Surgery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine Cairo University

Cairo, Al-Manial Cairo, 11956, Egypt

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Central Study Contacts

Ahmed Eid Aziz, Lecturer

CONTACT

+201127060844; Ahmed-eid@kasralainy.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 3, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)