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Clinical Trials/NCT07686783
NCT07686783RecruitingNot Applicable

Ovarian Reserve After Laparoscopic Cystectomy for Endometriotic and Non-Endometriotic Cysts: A Comparative Prospective Cohort Study

Benha University1 site in 1 country60 target enrollmentStarted: June 30, 2026Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
60
Locations
1
Primary Endpoint
Absolute Change in Serum Anti-Müllerian Hormone (AMH) Level
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

We will conduct this study to estimate the effect of laparoscopic cystectomy on ovarian reserve in endometriotic cysts versus non-endometriotic cysts.

Detailed Description

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.
  1. 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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Absolute Change in Serum Anti-Müllerian Hormone (AMH) Level

Time Frame: Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively

The absolute change in serum anti-Müllerian hormone (AMH) level from baseline to 3 months after laparoscopic ovarian cystectomy, calculated as the difference between preoperative AMH value (measured within 1 month before surgery) and postoperative AMH value (measured at 3 months after surgery). Comparison will be made between the endometriotic cyst group and the non-endometriotic cyst group.

Secondary Outcomes

  • Preoperative AMH Cutoff Value Predicting Postoperative AMH ≥ 1 ng/ml(Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively)
  • Change in Antral Follicle Count (AFC)(Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively)
  • Change in Serum Follicle-Stimulating Hormone (FSH) Level(Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively)
  • Correlation Between AMH Change and Clinical Variables(3 months postoperatively)
  • Intraoperative and Postoperative Complications(Intraoperative period, early postoperative period (24-48 hours), and up to 3 months postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Abdel Latif Ahmed Alnezamy

Principal Investigator and Lecturer of Obstetrics and Gynecology, Faculty of Medicine

Benha University

Study Sites (1)

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