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

NCT07686783 | Recruiting

• 1 other identifier: MS 53.4.2026
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ovarian Cysts; Endometriosis; Benign Ovarian Cyst; Ovarian Reserve; Cystectomy

Keywords

Laparoscopy; Cystectomy; Endometriotic Ovarian Cysts; Benign Ovarian Cysts; Ovarian Reserve Markers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Other Outcomes (2)

• Operative Time

  Intraoperative period

• Estimated Intraoperative Blood Loss

  Intraoperative period

Study Arms (2)

Endometriotic Cyst Group

EXPERIMENTAL

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

Non-Endometriotic Cyst Group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Laparoscopic cystectomy; ovarian cyst removal; laparoscopic ovarian conservation surgery

Endometriotic Cyst Group; Non-Endometriotic Cyst Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha Univesity Hospital

Banhā, Qalyubia Governorate, 13512, Egypt

RECRUITING

Related Publications (6)

• 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.

  PMID: 40611053 BACKGROUND

• 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.

  PMID: 11158655 BACKGROUND

• 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.

  PMID: 37370122 BACKGROUND

• 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.

  PMID: 30715359 RESULT

• 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.

  PMID: 20630505 RESULT

• 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.

  PMID: 36120464 RESULT

MeSH Terms

Conditions

Ovarian Cysts; Endometriosis

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• AHMED ALNEZAMY, MD

  Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AHMED ALNEZAMY, MD

CONTACT

01224849065; AHMED.ALNZAMY@fmed.bu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Lecturer of Obstetrics and Gynecology, Faculty of Medicine

Model Details: Patients with endometriotic cysts (Group 1) and patients with non-endometriotic cysts (Group 2) will be followed prospectively for 3 months post-surgery.

Study Record Dates

• First Submitted: June 27, 2026
• First Posted: July 7, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)