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

ConditionsOvarian Cysts Endometriosis Benign Ovarian Cyst Ovarian Reserve Cystectomy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-45

SponsorBenha University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Clinical or ultrasonic suspicion of ovarian malignancy

Ovarian cyst associated with pregnancy

Previous history of ovarian surgery

History of pelvic irradiation or chemotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

Laparoscopic Ovarian Cystectomy
Procedure/Surgery
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Endometriotic Cyst GroupExperimental treatment 1 intervention

Group B: Non-Endometriotic Cyst GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Secondary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

3 months postoperatively

Other outcomes

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.

Time frame

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).

Time frame

Intraoperative period

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benha University

Lead sponsor

Source ClinicalTrials.gov

Apply now