Laparoscopic Ovarian Cystectomy of Endometrioma vs Deroofing and Ovarian Reserve

March 25, 2015 updated by: Mohamed S Sweed, MD, Ain Shams University

Effect of Laparoscopic Ovarian Cystectomy of Endometrioma Versus Cyst Deroofing on Ovarian Reserve as Determined by Anti-mullerian Hormone and Antral Follicle Count: a Prospective Randomized Study.

The purpose of this study is to evaluate the impact of laparoscopic ovarian cystectomy versus laparoscopic cyst deroofing on ovarian reserve measured by serum levels of anti mullerian hormone and antral follicle count in patients with endometriomas.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

One of the major concerns about excision of endometriomas is their negative effect on ovarian reserve because of follicle loss, removal of endometriomas has been associated with poorer performance in IVF procedures, and decreased ovarian volumes have also been reported after surgery.Ovarian reserve is defined as the functional potential of the ovary which reflects the number and quality of the follicles left in the ovary, and is well-correlated with the response to ovarian stimulation using exogenous gonadotrophin. Over the years, various tests and markers of ovarian reserve have been reported; the static tests include serum markers, such as basal FSH, inhibin-B and anti-Mullerian hormone (AMH), and ultrasonographic markers, such as ovarian volume and antral follicle count.This study will include 122 patients aged between 18 and 35 years who have been diagnosed with endometrioma (unilateral or bilateral) and they are candidates for laparoscopic surgery. They will be selected according to inclusion and exclusion criteria.they will be randomized into two study groups, one study group will undergo laparoscopic ovarian cystectomy, the other study group will undergo laparoscopic cyst deroofing.AMH,AFC and ovarian volume will be measured pre-operative and post-operative.

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain Shams University Maternity Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age from 18-35 year
  2. Regular menstrual cycles.
  3. Endometrioma (unilateral or bilateral) diagnosed by transvaginal ultrasound with diameter ≥ 3 cm.

Exclusion criteria:

  1. Any previous ovarian surgery.

  2. Evidence of polycystic ovary syndrome according to Rotterdam criteria

    -Two of three of:

    • Oligo- or chronic anovulation.
    • Clinical and/or biochemical signs of hyperandrogenism.
    • Polycystic ovaries.
  3. Evidence of premature ovarian failure diagnosed by follicle stimulating hormone level ≥40 IU/L
  4. Any endocrinal disease affecting ovarian function e.g. thyroid dysfunction, hyperprolactinemia.
  5. Previous hormonal medications e.g. oral contraceptive pills, gonadotropin-releasing hormone analogue within the last 3 months before surgery.
  6. Any suspicious findings of ovarian malignant diseases diagnosed by transvaginal ultrasound.
  7. Contraindication to surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: laparoscopic ovarian cystectomy
laparoscopic ovarian cystectomy will be performed on proliferative phase of menstrual cycle.Anti-mullerian hormone level measurement and estimation of antral follicle count will be done before surgery and will be repeated one month after surgery.
Procedure: Laparoscopic ovarian cystectomy
will be performed using video control under general anesthesia, pneumoperitoneum is induced by carbon dioxide, with three 5-mm trocars in the lower abdomen and a 10-mm intraumbilical main trocar, and we will use 5-mm scissors and graspers, and Ringer's lactate solution for irrigation. Before initiating ovarian surgery, the ovaries are completely freed with obtuse and sharp dissection.after a cleavage plane between the cyst wall and ovarian cortex is identified, the ovaries are pulled slowly and gently in opposite directions by means of two a traumatic grasping forceps. After removing the pseudo capsule from the abdominal cavity, selective minimal (15 watt) bipolar coagulation of bleeding is performed, without excessive coagulation of the surgical defect to avoid damaging the ovary.
Active Comparator: laparoscopic cyst deroofing
laparoscopic cyst deroofing will be performed on proliferative phase of menstrual cycle.Anti-mullerian hormone level measurement and estimation of antral follicle count will be done before surgery and will be repeated one month after surgery.
Procedure: laparoscopic cyst deroofing
will be performed using video control under general anesthesia, pneumoperitoneum is induced by CO2, with three 5-mm trocars in the lower abdomen and a 10-mm intraumbilical main trocar, and we will use 5-mm scissors and graspers, and Ringer's lactate solution for irrigation. Before initiating ovarian surgery, the ovaries are completely freed with obtuse and sharp dissection. after mobilizing the ovary, the contents of the cyst is removed with the suction-irrigator probe and the cavity is irrigated. The inside of the cyst is evaluated and the portion of ovarian cortex involved with endometriosis is removed. Small blood vessels from the ovarian bed and bleeding from the ovarian hilum can be controlled with bipolar electro coagulation (15 watt). Low-power bipolar coagulation applied to the inside wall of the redundant ovarian capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
comparison between the impacts of laparoscopic ovarian cystectomy and laparoscopic cyst deroofing on ovarian reserve as determined by alteration of AMH level in endometrioma patients.
Time Frame: 17 months
17 months

Secondary Outcome Measures

Outcome Measure
Time Frame
comparison between the impacts of laparoscopic ovarian cystectomy and laparoscopic cyst deroofing on ovarian reserve as determined by antral follicle count estimation in endometrioma patients.
Time Frame: 17 months
17 months
comparison between the impacts of laparoscopic ovarian cystectomy and laparoscopic cyst deroofing on ovarian reserve as determined by ovarian volume estimation in endometrioma patients.
Time Frame: 17 months
17 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Director: Ahmed K. Makled, M.D., Assistant professor of Obstetrics & Gynecology, faculty of medicine, AinShams University
  • Principal Investigator: Mohamed S. Sweed, M.D., Lecturer Obstetics & Gynecolog, faculty of medicine, AinShams University
  • Principal Investigator: Neveen S. Mehanna, M.B.B.CH., AinShams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

March 6, 2013

First Submitted That Met QC Criteria

March 7, 2013

First Posted (Estimate)

March 11, 2013

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05081985
  • m120984 (Other Identifier: AinShams University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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