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

NCT ID: NCT03585309

Last Updated: 2018-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-15
• Study Completion Date: 2019-01-31

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 .

Conditions

Ovarian Endometrioma; Ovary Cyst

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparascopy comper with coagulation and without coagulation

Group Type: EXPERIMENTAL

The impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cysts:

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Zahra Hussein Mohammed Chewai

Resident of obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

kareem labib, MD

Role: PRINCIPAL_INVESTIGATOR

Ain shams University Maternity Hospital

Locations

Ain Shams University Maternity Hospital

Cairo, , Egypt

Countries

Egypt

Central Contacts

Ahmed Nagib, MD

Role: CONTACT

+201001403138

Kareem Labib, MD

Role: CONTACT

kareem_labib@yahoo.com

+201005115380

Facility Contacts

ahmed Nagib, MD

Role: primary

00201001403138

Kareem Labib, MD

Role: backup

kareem_labib@yahoo.com

00201005115380

References

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.

Reference Type: BACKGROUND

PMID: 26493551 (View on PubMed)

Other Identifiers

Ain shamsMH

Identifier Type: -

Identifier Source: org_study_id