NCT07446972

Impact of Bariatric Surgery on Female Sexual Function and Sex Hormones

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Morbid Obesity

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-08-01
• Completion: 2026-11-01
• First posted: 2026-03-03
• Last updated: 2026-03-04

Locations

1 site across 1 country: Egypt