Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01808170
Other study ID # 05081985
Secondary ID m120984
Status Completed
Phase N/A
First received March 6, 2013
Last updated March 25, 2015
Start date March 2013
Est. completion date August 2014

Study information

Verified date March 2015
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date August 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 35 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
Egypt Ain Shams University Maternity Hospital Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 17 months No
Secondary 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. 17 months No
Secondary comparison between the impacts of laparoscopic ovarian cystectomy and laparoscopic cyst deroofing on ovarian reserve as determined by ovarian volume estimation in endometrioma patients. 17 months No
See also
  Status Clinical Trial Phase
Completed NCT01268930 - Comparison of Hemostatic Matrix and Bipolar Coagulation in Surgical Treatment of Endometriomas N/A
Completed NCT05323539 - Comparison of Thyroid Volumes in Patients With and Without Endometrioma N/A
Recruiting NCT04178876 - Comparison of Laparoscopic Endometrioma Stripping Versus Ethanol Sclerotherapy( CLESS) N/A
Completed NCT06421857 - Hemostatic Measures During Laparoscopic Cystectomy for Endometrioma N/A
Recruiting NCT04151433 - Conservative Endometrioma Surgery N/A
Completed NCT01942122 - DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis Phase 2/Phase 3
Withdrawn NCT00999479 - Post Operative Continuous Active Combination Sex Steroids for the Prevention of Recurrent Endometrioma Formation N/A
Recruiting NCT03687398 - Genomic Maps of Endometrial Tissues of Patients With Endometriosis and Healthy Controls
Not yet recruiting NCT06377553 - PET/MRI for Evaluation of Endometriosis
Not yet recruiting NCT03788720 - Suture of the Ovary After Enucleation of Ovarian Endometrioma N/A
Completed NCT01982526 - Role of Anti Mullerian Hormone for Ovarian Reserve Determination of Preoperative and Postoperative Endometrioma Patients
Recruiting NCT05962775 - Ethanol Sclerotherapy Prior to ART N/A
Completed NCT03484546 - Optimum Menstrual Cycle Time for Endometrioma Excision
Recruiting NCT05637073 - Effect of Management of the Endometrioma on Ovarian Reserve
Completed NCT06219044 - Evaluation of Ovarian Reserve and Recurrence Rate After DWLS Diode Laser OMA Vaporization N/A
Recruiting NCT03620838 - Endometrioma Per se Versus Treatment Related Reduction in Ovarian Reserve (ERROR-2 Trial)
Terminated NCT03571776 - Anti-mullerian Hormone (AMH) After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery: Clinical Trial N/A
Enrolling by invitation NCT02472873 - Efficacy of Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas N/A
Completed NCT04941833 - Desogestrel for the Preoperative Treatment of Endometrioma Compared With Placebo Phase 2/Phase 3
Completed NCT06274086 - Two-session Catheter-directed Sclerotherapy Using Ethanol for Endometrioma N/A