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

Official title

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

Overview

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. 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.

Interventions

• 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

Primary outcome measures

• Absolute Change in Serum Anti-Müllerian Hormone (AMH) Level [Time frame: Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively]

Secondary outcome measures (5)

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Benha Univesity Hospital — Banhā

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. PMID 40611053
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07686783 · MS 53.4.2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗