Impact of Bariatric Surgery on Female Sexual Function, Sex Hormones, and Psychological Well-Being: A Prospective Cohort Study With Partner Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Female Sexual Function
研究概览
简要总结
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.
详细描述
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;
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Sleeve Gastrectomy (Procedure)
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.
干预措施: Gastric Bypass (Procedure)
结局指标
主要结局
Change in Female Sexual Function
时间窗: 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.
Change in Sex Hormone Levels
时间窗: 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.
次要结局
- 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)
- Correlation Between Mood Improvement and Sexual Function Improvement(Baseline to 6 months post-operative)
- Correlation Between Hormonal Changes and Sexual Function Improvement(Baseline to 6 months post-operative)
研究者
Ahmed Eid Ali Ahmed Aziz
Lecturer
Cairo University