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

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

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

Study Overview

• Status: Recruiting
• Conditions: Ovarian Cysts; Endometriosis; Ovarian Reserve; Benign Ovarian Cyst; Cystectomy
• Intervention / Treatment: Procedure: Laparoscopic Ovarian Cystectomy

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.

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: AHMED ALNEZAMY, MD; Phone Number: 01224849065; Email: AHMED.ALNZAMY@fmed.bu.edu.eg

Study Locations

• Egypt
  • Qalyubia Governorate
    • Banhā, Qalyubia Governorate, Egypt, 13512
      • Recruiting
      • Benha Univesity Hospital
      • Contact: AHMED ALNEZAMY, MD; Phone Number: 00201224849065; Email: AHMED.ALNZAMY@fmed.bu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endometriotic Cyst Group; Patients with endometriotic ovarian cysts (endometriomas) diagnosed by transvaginal ultrasound or MRI, confirmed by histopathological examination postoperatively. Participants will undergo laparoscopic ovarian cystectomy under general anesthesia. The procedure involves excision of the cyst wall from adjacent ovarian tissue using traction with grasping forceps, hemostasis achieved via electrocoagulation or sutures, and plication of ovarian incision edges. Any visible endometriotic lesions within the pelvic cavity will be excised or cauterized as appropriate. All patients will be followed up at 3 months postoperatively with serum AMH, FSH, and transvaginal ultrasound for AFC assessment.	Procedure: Laparoscopic Ovarian Cystectomy; 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
Active Comparator: Non-Endometriotic Cyst Group; Patients with non-endometriotic benign ovarian cysts (including dermoid cysts, serous cystadenomas, mucinous cystadenomas, and other benign cysts) diagnosed by transvaginal ultrasound or MRI, confirmed by histopathological examination postoperatively. Participants will undergo laparoscopic ovarian cystectomy under general anesthesia. The procedure involves excision of the cyst wall from adjacent ovarian tissue using traction with grasping forceps, hemostasis achieved via electrocoagulation or sutures, and plication of ovarian incision edges. All patients will be followed up at 3 months postoperatively with serum AMH, FSH, and transvaginal ultrasound for AFC assessment.	Procedure: Laparoscopic Ovarian Cystectomy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change in Serum Anti-Müllerian Hormone (AMH) Level	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.	Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Time	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.	Intraoperative period
Estimated Intraoperative Blood Loss	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).	Intraoperative period

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: AHMED ALNEZAMY, MD, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University

Publications and helpful links

General Publications

• Kindan A, Kindan A, Kurt A, Akbulut VO, Dilbaz B. Effects of benign ovarian cyst volume and laterality on AMH and CA-125 levels. BMC Womens Health. 2025 Jul 4;25(1):305. doi: 10.1186/s12905-025-03842-9.
• Woodward PJ, Sohaey R, Mezzetti TP Jr. Endometriosis: radiologic-pathologic correlation. Radiographics. 2001 Jan-Feb;21(1):193-216; questionnaire 288-94. doi: 10.1148/radiographics.21.1.g01ja14193.
• Wu Q, Yang Q, Lin Y, Wu L, Lin T. The optimal time for laparoscopic excision of ovarian endometrioma: a prospective randomized controlled trial. Reprod Biol Endocrinol. 2023 Jun 27;21(1):59. doi: 10.1186/s12958-023-01109-2.
• Younis JS, Shapso N, Fleming R, Ben-Shlomo I, Izhaki I. Impact of unilateral versus bilateral ovarian endometriotic cystectomy on ovarian reserve: a systematic review and meta-analysis. Hum Reprod Update. 2019 May 1;25(3):375-391. doi: 10.1093/humupd/dmy049.
• Iwase A, Hirokawa W, Goto M, Takikawa S, Nagatomo Y, Nakahara T, Manabe S, Kikkawa F. Serum anti-Mullerian hormone level is a useful marker for evaluating the impact of laparoscopic cystectomy on ovarian reserve. Fertil Steril. 2010 Dec;94(7):2846-9. doi: 10.1016/j.fertnstert.2010.06.010. Epub 2010 Jul 14.
• Mansouri G, Safinataj M, Shahesmaeili A, Allahqoli L, Salehiniya H, Alkatout I. Effect of laparoscopic cystectomy on ovarian reserve in patients with ovarian cyst. Front Endocrinol (Lausanne). 2022 Aug 30;13:964229. doi: 10.3389/fendo.2022.964229. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 27, 2026
• First Submitted That Met QC Criteria: July 2, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Cystectomy; Laparoscopy; Endometriotic Ovarian Cysts; Benign Ovarian Cysts; Ovarian Reserve Markers
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Cysts; Endometriosis; Ovarian Cysts
• Other Study ID Numbers: MS 53.4.2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No