Clinical trial

Impact of Bariatric Surgery on Female Sexual Function and Sex Hormones

Recruiting now · Not applicable · 1 countries · Registry ID NCT07446972

Recruiting nowNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 45 Years

SexFemale

Healthy volunteersNot accepted

ConditionMorbid Obesity

Full registry criteria

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

Treatments and study arms

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.

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.

Primary outcomes

Change in Female Sexual FunctionBaseline 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.

Change in Sex Hormone LevelsBaseline 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Faculty of Medicine Cairo University🇪🇬 Cairo, Al-Manial Cairo, Egypt

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Mahmoud El Azhary, LecturerContact

Email · Call +201064110221