Impact of Bariatric Surgery on Female Sexual Function and Sex Hormones
ConditionMorbid Obesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Women who are not sexually active
Post-menopausal women (amenorrhea ≥12 months without other cause)
Current pregnancy or lactation
Antidepressants
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Sleeve Gastrectomy
Procedure/SurgeryLaparoscopic 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/SurgeryLaparoscopic 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Women Undergoing Bariatric Surgery2 interventions
Trial outcomes
Primary outcomes
1
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-operative2
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-operativeSecondary outcomes
1
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-operative2
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-operative3
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-operative4
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-operativeSponsors and contacts
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Source ClinicalTrials.gov