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Laparoscopic Ovarian Cystectomy of Endometrioma vs Deroofing and Ovarian Reserve

Primary Purpose

Endometrioma

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Laparoscopic ovarian cystectomy
laparoscopic cyst deroofing
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endometrioma focused on measuring Laparoscopy, AMH, AFC, Endometrioma, ovarian reserve, Ovarian cystectomy, ovarian cyst deroofing

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ain Shams University Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

laparoscopic ovarian cystectomy

laparoscopic cyst deroofing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
comparison between the impacts of laparoscopic ovarian cystectomy and laparoscopic cyst deroofing on ovarian reserve as determined by ovarian volume estimation in endometrioma patients.

Full Information

First Posted
March 6, 2013
Last Updated
March 25, 2015
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT01808170
Brief Title
Laparoscopic Ovarian Cystectomy of Endometrioma vs Deroofing and Ovarian Reserve
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrioma
Keywords
Laparoscopy, AMH, AFC, Endometrioma, ovarian reserve, Ovarian cystectomy, ovarian cyst deroofing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic ovarian cystectomy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
laparoscopic cyst deroofing
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ovarian cystectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic cyst deroofing
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age from 18-35 year Regular menstrual cycles. Endometrioma (unilateral or bilateral) diagnosed by transvaginal ultrasound with diameter ≥ 3 cm. Exclusion criteria: Any previous ovarian surgery. 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. Evidence of premature ovarian failure diagnosed by follicle stimulating hormone level ≥40 IU/L Any endocrinal disease affecting ovarian function e.g. thyroid dysfunction, hyperprolactinemia. Previous hormonal medications e.g. oral contraceptive pills, gonadotropin-releasing hormone analogue within the last 3 months before surgery. Any suspicious findings of ovarian malignant diseases diagnosed by transvaginal ultrasound. Contraindication to surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed K. Makled, M.D.
Organizational Affiliation
Assistant professor of Obstetrics & Gynecology, faculty of medicine, AinShams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed S. Sweed, M.D.
Organizational Affiliation
Lecturer Obstetics & Gynecolog, faculty of medicine, AinShams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Neveen S. Mehanna, M.B.B.CH.
Organizational Affiliation
AinShams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
30193971
Citation
Sweed MS, Makled AK, El-Sayed MA, Shawky ME, Abd-Elhady HA, Mansour AM, Mohamed RM, Hemeda H, Nasr-Eldin EA, Attia NS, Eltaieb E, Allam H, Hussein A. Ovarian Reserve Following Laparoscopic Ovarian Cystectomy vs Cyst Deroofing for Endometriomas. J Minim Invasive Gynecol. 2019 Jul-Aug;26(5):877-882. doi: 10.1016/j.jmig.2018.06.022. Epub 2018 Sep 5.
Results Reference
derived

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Laparoscopic Ovarian Cystectomy of Endometrioma vs Deroofing and Ovarian Reserve

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