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RecruitingNCT07686783Updated Sep 30, 2026

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

An interventional study of Laparoscopic Ovarian Cystectomy in Ovarian Cysts, Endometriosis and Benign Ovarian Cyst, sponsored by Benha University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Benha University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

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

Read the 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.
02

Conditions studied

  • Ovarian Cysts
  • Endometriosis
  • Benign Ovarian Cyst
  • Ovarian Reserve
  • Cystectomy

Keywords

  • Laparoscopy
  • Cystectomy
  • Endometriotic Ovarian Cysts
  • Benign Ovarian Cysts
  • Ovarian Reserve Markers
03

In context

Ovarian Cysts

80 studies on the registry are indexed under Ovarian Cysts; 16 are open to participants now.

This study's planned enrollment of 60 is below the median of 74 across 51 interventional studies indexed under Ovarian Cysts.

Browse Ovarian Cysts studies →

Lead sponsor

Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

Exclusion Criteria:

  • Clinical or ultrasonic suspicion of ovarian
  • 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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • ProcedureLaparoscopic 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.

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

06

What researchers measure

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.

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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

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

Other outcomes

  1. 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

  2. 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

07

Study locations

1 of 1 sites recruiting
  • Benha Univesity Hospital
    Banhā, Qalyubia Governorate 13512, Egypt
    Recruiting
08

References and documents

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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 36120464 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date and date precision
1 update, last Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Minor edits only
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07686783
Lead sponsor
Benha University
Responsible party
Ahmed Abdel Latif Ahmed Alnezamy (Principal Investigator and Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University) — Principal investigator
First posted
Jul 7, 2026
Start date
Jun 30, 2026
Primary completion
Jun 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

AHMED ALNEZAMY, MD
Contact
AHMED.ALNZAMY@fmed.bu.edu.eg
01224849065
AHMED ALNEZAMY, MD
principal investigator · Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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