Laparoscopic Ovarian Cystectomy of Endometrioma vs Deroofing and Ovarian Reserve

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Ain Shams University
Sponsor:
Information provided by (Responsible Party):
Mohamed S Sweed, MD, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01808170
First received: March 6, 2013
Last updated: May 11, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Endometrioma
Procedure: Laparoscopic ovarian cystectomy
Procedure: laparoscopic cyst deroofing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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.

Further study details as provided by Ain Shams University:

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. [ Time Frame: 17 months ] [ Designated as safety issue: No ]

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. [ Time Frame: 17 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 122
Study Start Date: March 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01808170

Contacts
Contact: Mohamed S. Sweed, M.D. 01001222047 ext +2 drmsweed@gmail.com

Locations
Egypt
Ain Shams University Maternity Hospital Recruiting
Cairo, Egypt
Contact: Ahmed K. Makled, M.D.       drahmedmakled@live.com   
Sub-Investigator: Neveen S. Mehanna, M.B.B.CH.         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Mohamed S Sweed, MD, Mohamed S. Sweed lecturer of Obstetrics & Gynecology AinShams University., Ain Shams University
ClinicalTrials.gov Identifier: NCT01808170     History of Changes
Other Study ID Numbers: 05081985, m120984
Study First Received: March 6, 2013
Last Updated: May 11, 2014
Health Authority: Egypt: Institutional Review Board

Keywords provided by Ain Shams University:
Laparoscopy
AMH
AFC
Endometrioma
ovarian reserve
Ovarian cystectomy
ovarian cyst deroofing

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 01, 2014