Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cysts.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03585309
Recruitment Status : Not yet recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Zahra Hussein Mohammed Chewai, Ain Shams University

Brief Summary:
The aim of the study is to evaluate the effect of bipolar electrocoagulation on ovarian reserve.

Condition or disease Intervention/treatment Phase
Ovarian Endometrioma Ovary Cyst Procedure: The impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cysts: Not Applicable

Detailed Description:

Laparoscopic ovarian cystectomy is currently considered the treatment of choice in women with benign ovarian cysts and has gained increasing acceptance among gynecologic sur¬geons . However, the safety of this technique in terms of ovarian damage to the operated gonad has recently been questioned. A great deal of evidence supports that the re¬moval of ovarian cysts is associated with injury to the ovarian reserve . Many of these studies involved patients who required assisted reproduction, and they found that the number both of follicles and retrieved oocytes obtained in the operated gonad during ovarian hyperstimulation was markedly reduced when compared with the contralateral intact ovary. However, most of these studies applied ovarian response to gonadotropin hyperstimulation to measure the ovarian reserve. It has been argued that these patients are not representative of all patients undergoing laparoscopic ovarian cystectomy in terms of ovarian damage because these data were acquired from aggressive gonadotropin stimulation which is thought to be different from a natural menstrual cycle .

On the other hand, because ovarian reserve cannot be mea¬sured directly, the evaluation of ovarian reserve is difficult to carry out. The induction of ovarian hyperstimulation in an un¬selected population of surgical patients for the purpose of evaluating ovarian reserve is obviously ethically untenable. The serum level of follicle-stimulating hormone (FSH) is a predictor of functional ovarian reserve , but its usefulness is limited considering that the vast majority of patients un¬dergo monolateral excision of a cyst and the contralateral in¬tact gonad may completely substitute for reduced function of the operated ovary . Given the well-established role of ul¬trasound scanning in the diagnosis and follow-up of ovarian cysts, reported that basal antral follicle number and mean ovarian diameter could be used as indicators of ovarian reserve. found that the value of ovarian stromal blood flow velocity was an initial marker of ovarian reserve before the change of FSH level and ovarian volume.

With the combined use of serum hormonal evaluation and ultrasound examination, the investigators prospectively investigated the ovarian reserve of patients after the excision of benign ovarian cysts. The damage to ovarian reserve was evaluated during through a 12-month follow-up period after the application of bipolar, ultrasonic scalpel electrocoagulation or suture for ovarian cystectomy .


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cysts: Randomization Clinical Trial
Estimated Study Start Date : July 15, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cysts

Arm Intervention/treatment
Experimental: Laparascopy comper with coagulation and without coagulation Procedure: The impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cysts:

Randomization Randomization will be conducted using computer generated table. Group A (48 CASES) without coagulation

Group A 6 89 92 35 1 15 21 16 60 49 53 91 34 5 94 64 88 58 7 33 8 75 29 56 10 23 37 19 32 71 55 84 36 77 50 2 46 70 82 9 51 54 72 18 25 31 14 63

Group B (48 CASES) with coagulation Group B 79 38 93 43 52 44 62 47 68 76 86 95 81 83 42 80 94 30 78 61 12 17 66 13 41 59 22 73 39 65 4 90 28 26 3 87 40 85 69 48 27 24 74 57 11 20 67 45

Allocation and concealment Nineteen six opaque envelopes will be numbered serially and in each envelope the corresponding letter which denotes the allocated group will be put according to randomization table then all envelopes will be closed and put in one box. When the first patient arrives the first envelope will be opened and the patient will be allocated according to the letter inside.





Primary Outcome Measures :
  1. Number of participants (Females) with ovarian cyst or dermid cyst or endometrial [ Time Frame: 3 months after surgery ]
    Laparascopy without coagulation excision of ovarian cysts and effect of ovarian reserve RESULIT The result of the study is to evaluate the effect of bipolar electrocoagulation on ovarian reserve.


Secondary Outcome Measures :
  1. Number of participants (Females) with ovarian cyst or dermid cyst or endometrial [ Time Frame: 3 months after surgery ]
    Laparascopy with coagulation excision of ovarian cysts and effect of ovarian reserve RESULT The result of the study is to evaluate the effect of bipolar electrocoagulation on ovarian reserve.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: 20-35 years.
  2. Uni-bilateral ovarian cyst(s) size without clinical and sonographic suspicion of ovarian cancer.
  3. Regular menstrual cycles defined as a cycle length between 25 and 35 days in the 6 months before surgery.
  4. Agreement to be enrolled in the study.
  5. Endometriosi.
  6. Renal disesase.
  7. Liver disease.

Exclusion Criteria:

  • 1- Prior ovarian surgery 2- Surgical necessity to perform adnexectomy 3- Known endocrine disease 4- Postoperative pathologic diagnosis that was not benign ovarian cyst 5- Oral contraceptive use before surgery last two months. 6-Addison disease. 7.Thyroid disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585309


Contacts
Layout table for location contacts
Contact: Ahmed Nagib, MD +201001403138
Contact: Kareem Labib, MD +201005115380 kareem_labib@yahoo.com

Locations
Layout table for location information
Egypt
Ain Shams University Maternity Hospital Not yet recruiting
Cairo, Egypt, 1156
Contact: ahmed Nagib, MD    00201001403138      
Contact: Kareem Labib, MD    00201005115380    kareem_labib@yahoo.com   
Sponsors and Collaborators
Ain Shams University
Investigators
Layout table for investigator information
Principal Investigator: kareem labib, MD Ain shams University Maternity Hospital

Publications:
Layout table for additonal information
Responsible Party: Zahra Hussein Mohammed Chewai, Resident of obstetrics and gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT03585309     History of Changes
Other Study ID Numbers: Ain shamsMH
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Cysts
Endometriosis
Ovarian Cysts
Neoplasms
Pathological Conditions, Anatomical
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases