The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cysts.
Primary Purpose
Ovarian Endometrioma, Ovary Cyst
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
The impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cysts:
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Endometrioma
Eligibility Criteria
Inclusion Criteria:
- Age: 20-35 years.
- Uni-bilateral ovarian cyst(s) size without clinical and sonographic suspicion of ovarian cancer.
- Regular menstrual cycles defined as a cycle length between 25 and 35 days in the 6 months before surgery.
- Agreement to be enrolled in the study.
- Endometriosi.
- Renal disesase.
- 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.
Sites / Locations
- Ain Shams University Maternity Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Laparascopy comper with coagulation and without coagulation
Arm Description
Outcomes
Primary Outcome Measures
Number of participants (Females) with ovarian cyst or dermid cyst or endometrial
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
Number of participants (Females) with ovarian cyst or dermid cyst or endometrial
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03585309
Brief Title
The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cysts.
Official Title
The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cysts: Randomization Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2018 (Anticipated)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
January 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of the study is to evaluate the effect of bipolar electrocoagulation on ovarian reserve.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Endometrioma, Ovary Cyst
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Laparascopy comper with coagulation and without coagulation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
The impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cysts:
Intervention Description
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 Measure Information:
Title
Number of participants (Females) with ovarian cyst or dermid cyst or endometrial
Description
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.
Time Frame
3 months after surgery
Secondary Outcome Measure Information:
Title
Number of participants (Females) with ovarian cyst or dermid cyst or endometrial
Description
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.
Time Frame
3 months after surgery
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 20-35 years.
Uni-bilateral ovarian cyst(s) size without clinical and sonographic suspicion of ovarian cancer.
Regular menstrual cycles defined as a cycle length between 25 and 35 days in the 6 months before surgery.
Agreement to be enrolled in the study.
Endometriosi.
Renal disesase.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Nagib, MD
Phone
+201001403138
First Name & Middle Initial & Last Name or Official Title & Degree
Kareem Labib, MD
Phone
+201005115380
Email
kareem_labib@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kareem labib, MD
Organizational Affiliation
Ain shams University Maternity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
ZIP/Postal Code
1156
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ahmed Nagib, MD
Phone
00201001403138
First Name & Middle Initial & Last Name & Degree
Kareem Labib, MD
Phone
00201005115380
Email
kareem_labib@yahoo.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
26493551
Citation
Asgari Z, Rouholamin S, Hosseini R, Sepidarkish M, Hafizi L, Javaheri A. Comparing ovarian reserve after laparoscopic excision of endometriotic cysts and hemostasis achieved either by bipolar coagulation or suturing: a randomized clinical trial. Arch Gynecol Obstet. 2016 May;293(5):1015-22. doi: 10.1007/s00404-015-3918-4. Epub 2015 Oct 22.
Results Reference
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The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cysts.
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