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Ovarian CystsNCT07686783

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

A study testing Laparoscopic Ovarian Cystectomy in people with Ovarian Cysts and Endometriosis, run by Benha University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Ovarian Cysts, Endometriosis, Benign Ovarian Cyst
What is being tested?
Laparoscopic Ovarian Cystectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
30 Jun 2026to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

AHMED ALNEZAMY, MD contact

01224849065

AHMED.ALNZAMY@fmed.bu.edu.eg

Egypt1 site, 1 recruiting
  • Benha Univesity Hospital

    Banhā, Qalyubia Governorate, 13512

    AHMED ALNEZAMY, MD, 00201224849065, AHMED.ALNZAMY@fmed.bu.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: 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.

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.
  1. 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.
  1. 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.
Being tested
Laparoscopic Ovarian Cystectomy
Keywords
Laparoscopy, Cystectomy, Endometriotic Ovarian Cysts, Benign Ovarian Cysts, Ovarian Reserve Markers
Medical subject headings
Ovarian Cysts, Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic Ovarian CystectomyProcedure or surgery

    Also called Laparoscopic cystectomy; ovarian cyst removal; laparoscopic ovarian conservation 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.

Study groups in NCT07686783
Study groupRoleWhat they receive
Endometriotic Cyst GroupExperimentalPatients 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.
Receives: Procedure: Laparoscopic Ovarian Cystectomy
Non-Endometriotic Cyst GroupActive comparatorPatients 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.
Receives: Procedure: Laparoscopic Ovarian Cystectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2026
  2. Study start30 Jun 2026
  3. Primary completionJun 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Patients with endometriotic cysts (Group 1) and patients with non-endometriotic cysts (Group 2) will be followed prospectively for 3 months post-surgery.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07686783
Sponsor's protocol ID
MS 53.4.2026
Status last verified
Sep 2026
First submitted
27 Jun 2026
Last updated
30 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic Ovarian Cystectomy in people with Ovarian Cysts and Endometriosis, run by Benha University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AHMED ALNEZAMY, MD (01224849065, AHMED.ALNZAMY@fmed.bu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absolute Change in Serum Anti-Müllerian Hormone (AMH) Level (time frame: Baseline (preoperative, within 1 month before surgery) and 3 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07686783, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.

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