NCT03585309

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

July 15, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

July 13, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

May 7, 2018

Last Update Submit

July 11, 2018

Conditions

Ovarian EndometriomaOvary Cyst

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months after surgery

Secondary Outcomes (1)

  • Number of participants (Females) with ovarian cyst or dermid cyst or endometrial

    3 months after surgery

Study Arms (1)

Laparascopy comper with coagulation and without coagulation

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

Interventions

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

Laparascopy comper with coagulation and without coagulation

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, 1156, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 26493551BACKGROUND

MeSH Terms

Conditions

EndometriosisOvarian Cysts

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • kareem labib, MD

    Ain shams University Maternity Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Nagib, MD

CONTACT

+201001403138

Kareem Labib, MD

CONTACT

+201005115380kareem_labib@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of obstetrics and gynecology

Study Record Dates

First Submitted

May 7, 2018

First Posted

July 13, 2018

Study Start

July 15, 2018

Primary Completion

December 31, 2018

Study Completion

January 31, 2019

Last Updated

July 13, 2018

Record last verified: 2018-07

Locations

EG(1)