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Ovarian Reserve After Laparoscopic Cystectomy for Endometriotic and Non-Endometriotic Cysts

NCT07686783 · Benha University
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Official title
Ovarian Reserve After Laparoscopic Cystectomy for Endometriotic and Non-Endometriotic Cysts: A Comparative Prospective Cohort Study
About this study
After eligibility and consenting, all participants aged 18-45 years presented to Benha University or the Endometriosis center with ovarian cyst diagnosed via transvaginal ultrasound or MRI will undergo laparoscopic ovarian cystectomy. Data will be collected regarding, 1. Baseline clinical data will be collected by healthcare providers including age, BMI, parity, previous pelvic surgery, duration and type of infertility, duration of cyst once diagnosed till time of laparoscopic surgery, laterality of cyst and size. 2. Baseline ovarian reserve will include * AMH will be measured within 1 month before laparoscopic surgery. * AFC will be measured within 1 month preoperative via transvaginal ultrasound in the early follicular phase of the menstrual cycle (cycle days 2-4). * FSH will be measured within 1 month preoperative between day (2 and 4) of the menstrual cycle. 3. Intraoperative data will be collected by trained operating room nurse including: * Operative time which is the time lapse between insertion of Veress needle trocar for preparation till the removal of the 10 mm umbilical trocar. * Estimated intraoperative blood loss(mL) where it calculated by = (Total weight of wet gauze after surgery (g) - Total weight of dry gauze before surgery (g)) + (Amount of fluid in suction bucket (g) - Weight of flushing fluid (g)used) * laterality of the Cyst, number of cauterizations, cyst rupture, adverse effects including soft tissue or organ injury. 4. Postoperative follow up * Early postoperative follow up with first 24-48 hours during hospital admission recording complications such as fever, intraperitoneal hemorrhage or postoperative pain calculated by NPRS (Numeric Pain Rating Scale) (0-10) where 0 mean no pain and 10 mean intense or intolerable pain or through VAS (Visual Analogue Scale). * Longterm complications will be structurally soliced via telephone calls every 2 weeks till the end of the follow-up period including fever, surgical site infection, readmission or reoperation. * At 3-month postoperative AMH, FSH will be re-evaluated at the same laboratory, and AFC will be re-evaluated by the same ultrasonography.
Eligibility criteria
Inclusion Criteria: * Female patients aged 18-45 years * Ovarian cyst measuring 6-15 cm in diameter, confirmed by transvaginal ultrasound or MRI * Cyst is persistent for more than 3 months if asymptomatic, OR any symptomatic cyst regardless of duration of diagnosis * Serum anti-Müllerian hormone (AMH) level ≥ 2 ng/mL, measured within 1 month preoperatively * Willingness to participate and provide written informed consent Exclusion Criteria: * Clinical or ultrasonic suspicion of ovarian malignancy * Ovarian cyst associated with pregnancy * Previous history of ovarian surgery * History of pelvic irradiation or chemotherapy * Known endocrine disorders affecting ovarian function (e.g., PCOS, premature ovarian insufficiency, thyroid dysfunction, hyperprolactinemia) * Current use of hormonal contraceptives or hormonal therapy within 3 months prior to enrollment * Presence of severe systemic disease that contraindicates surgery or general anesthesia * Refusal to participate or inability to provide informed consent
Study design
Enrollment target: 60 participants
Allocation: non_randomized
Masking: none
Age groups: adult
Timeline
Starts: 2026-06-30
Estimated completion: 2027-09
Last updated: 2026-07-07
Interventions
Procedure: Laparoscopic Ovarian Cystectomy
Primary outcomes
  • Absolute Change in Serum Anti-Müllerian Hormone (AMH) Level (Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively)
Sponsor
Benha University · other
Contacts & investigators
ContactAHMED ALNEZAMY, MD · contact · AHMED.ALNZAMY@fmed.bu.edu.eg · 01224849065
InvestigatorAHMED ALNEZAMY, MD · principal_investigator, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University
All locations (1)
Benha Univesity HospitalRecruiting
Banhā, Qalyubia Governorate, Egypt
Ovarian Reserve After Laparoscopic Cystectomy for Endometriotic and Non-Endometriotic Cysts · TrialPath