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NCT Number: NCT07686783

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

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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Benha Univesity Hospital

Banhā, Qalyubia Governorate, 13512, Egypt

Location status: Recruiting

Location contact

AHMED ALNEZAMY, MD

CONTACT

[email protected]

00201224849065

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,

  • 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.
  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic ovarian cystectomy

Procedure

Laparoscopic excision of ovarian cyst under general anesthesia. The procedure includes: (1) CO₂ pneumoperitoneum creation via Veress needle through a 1-cm umbilical incision until intraabdominal pressure reaches 15 mmHg; (2) insertion of a 10-mm umbilical trocar and telescope; (3) placement of two or more 5-mm ancillary trocars under direct visualization; (4) incision of the ovarian capsule using monopolar scissors; (5) identification and careful dissection of the cyst wall from adjacent ovarian tissue using traction with grasping forceps; (6) hemostasis achieved using electrocoagulation or sutures; (7) plication and approximation of the ovarian incision edges; (8) for endometriosis cases, excision or cauterization of visible endometriotic lesions; (9) histopathological examination of the excised specimen to confirm diagnosis. The procedure is performed in both arms (endometriotic and non-endometriotic cysts) using identical surgical techniques.

Other names: Laparoscopic cystectomy; ovarian cyst removal; laparoscopic ovarian conservation surgery

Primary outcomes

  1. 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

  1. Preoperative AMH Cutoff Value Predicting Postoperative AMH ≥ 1 ng/ml

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

    Receiver operating characteristic (ROC) curve analysis to determine the optimal preoperative serum AMH cutoff value that predicts maintenance of serum AMH ≥ 1 ng/ml at 3 months postoperatively. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) will be calculated.

  2. Change in Antral Follicle Count (AFC)

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

    The change in antral follicle count (AFC) from baseline to 3 months after laparoscopic ovarian cystectomy, assessed via transvaginal ultrasound in the early follicular phase (cycle days 2-4). Comparison will be made between endometriotic and non-endometriotic cyst groups.

  3. Change in Serum Follicle-Stimulating Hormone (FSH) Level

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

    The change in serum follicle-stimulating hormone (FSH) level from baseline to 3 months after laparoscopic ovarian cystectomy, measured on cycle days 2-4. Comparison will be made between endometriotic and non-endometriotic cyst groups.

  4. Correlation Between AMH Change and Clinical Variables

    Time frame: 3 months postoperatively

    Analysis of the correlation between the change in serum AMH level and various clinical variables, including number of cauterizations, cyst size (cm), laterality (unilateral/bilateral), cyst type (endometriotic/non-endometriotic), age (years), and body mass index (BMI, kg/m²). Pearson or Spearman's rank correlation coefficients will be calculated as appropriate.

  5. Intraoperative and Postoperative Complications

    Time frame: Intraoperative period, early postoperative period (24-48 hours), and up to 3 months postoperatively

    Description and comparison of intraoperative and postoperative complications between the endometriotic and non-endometriotic cyst groups, including: intraoperative cyst rupture, organ injury (bladder, bowel, uterus, fallopian tubes, major blood vessels), hemorrhage; early postoperative complications (within 24-48 hours) including fever, intraperitoneal hemorrhage, and postoperative pain measured by NPRS (0-10) or VAS; and long-term complications (up to 3 months) including surgical site infection, readmission, reoperation, and cyst persistence or recurrence.

Other outcomes

  1. Operative Time

    Time frame: Intraoperative period

    Comparison of operative time (minutes) between the endometriotic and non-endometriotic cyst groups. Operative time is defined as the time lapse between insertion of the Veress needle trocar for preparation until the removal of the 10 mm umbilical trocar.

  2. Estimated Intraoperative Blood Loss

    Time frame: Intraoperative period

    Comparison of estimated intraoperative blood loss (mL) between the endometriotic and non-endometriotic cyst groups. Blood loss will be calculated as: (Total weight of wet gauze after surgery in grams - Total weight of dry gauze before surgery in grams) + (Amount of fluid in suction bucket in grams - Weight of flushing fluid used in grams).

Study contacts

Contact information is provided by the study sponsor or research team.

AHMED ALNEZAMY, MD

CONTACT

[email protected]

01224849065

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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