An observational study in Morbid Obesity, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Cairo University · Observational
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:
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:
What participants will do:
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.
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:
Psychometric assessments:
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.
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's planned enrollment of 40 is below the median of 78 across 306 observational studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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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.
Exclusion Criteria:
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
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.
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.
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.
Time frame: 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.
Time frame: Baseline and 6 months post-operative
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.
Time frame: Baseline and 6 months post-operative
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.
Time frame: Baseline and 6 months post-operative
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.
Time frame: Baseline and 6 months post-operative
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."
Time frame: Baseline and 6 months post-operative
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.
Time frame: Baseline and 6 months post-operative
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.
Time frame: Baseline to 6 months post-operative
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.
Time frame: Baseline to 6 months post-operative
Plan to share: No
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Cairo University