The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cysts.
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|ClinicalTrials.gov Identifier: NCT03585309|
Recruitment Status : Not yet recruiting
First Posted : July 13, 2018
Last Update Posted : July 13, 2018
|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|
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 .
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585309
|Contact: Ahmed Nagib, MD||+201001403138|
|Contact: Kareem Labib, MDfirstname.lastname@example.org|
|Ain Shams University Maternity Hospital|
|Cairo, Egypt, 1156|
|Contact: ahmed Nagib, MD 00201001403138|
|Contact: Kareem Labib, MD 00201005115380 email@example.com|
|Principal Investigator:||kareem labib, MD||Ain shams University Maternity Hospital|