Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201205000382185 Date of Approval: 11/05/2012
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A modified technique of laparoscopic ovarian drilling for polycystic ovary syndrome using Harmonic scalpel
Official scientific title A modified technique of laparoscopic ovarian drilling for polycystic ovary syndrome using Harmonic scalpel
Brief summary describing the background and objectives of the trial Introduction: Polycystic ovary syndrome is the most common cause of anovulatory infertility affecting between 4% and 6% of women of reproductive age.Laparoscopic ovarian drilling (LOD) can resolve infertility within 4-6 months in 50 -60 % of couples. So a strategy with LOD in women with PCOS will shorten the time to pregnancy, reduce the need for medical ovulation induction and enable diagnosis of those women with anatomic infertility who can achieve pregnancy only by IVF treatment.Objective: To review our experience with a modified technique of laparoscopic ovarian drilling using harmonic scalpel in Clomiphene resistant PCOS
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied clomiphene resistant polycystic ovary syndrome
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/01/2009
Actual trial start date 15/02/2009
Anticipated date of last follow up 30/09/2010
Actual Last follow-up date 31/12/2010
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 60
Recruitment status Stopped early/ terminated
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group laparoscopic ovarian drilling using harmonic scalpel 3-4 drilling points 2-3 seconds We used the only active (vibrating) blade of laparoscopic coagulation shear (LCS) which has a tip of about 1 mm and a length of about 1 cm. After activation of the blade, the ovaries were drilled using the whole length of the active blade. 30
Control Group electrocautery laparoscopic ovarian drilling 100 Watt was used to aid the entry of the needle for 3-4 points 2-3 seconds The drilling was performed using an insulated unipolar electrocautery needle electrode. The uninsulated part of the needle was 8 mm long and its diameter was < 1 mm 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
anovulatory infertility due to pcos. clomiphen resistant age: 20-30 years normal semen analysis of the husband no previous abominal surgical intervention infertility due to causes other than pcos. age below 20 or above 30 abnormal semen analysis previous abdominal surgery 20 Year(s) 30 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 03/12/2008 AL AZHAR ETHICAL COMMITTEE
Ethics Committee Address
Street address City Postal code Country
AL AZHAR SQUARE assiut 71111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ovulation rate and pregnancy rate. 6 monthes
Secondary Outcome menstrual regularity, BMI, ovarian volume, antral follicle count basal serum LH, FSH, LH/FSH ratio, total testosterone and estradiol changes and post operative adhesion formation after 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
infertility clinic at AL-AZHAR UNIVERSITY HOSPITAL AL- AZHAR SQUARE Assiut 71111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
AL AZHAR UNIVERSITY HOSPITAL AL- AZHAR SQUARE assiut 71111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor AL AZHAR UNIVERSITY HOSPITAL AL AZHAR SQUARE assiut 71111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Abd El-Naser Abd El-Gaber Ali AL- AZHAR SQUARE- ALAZHAR UNIVERSITY HOSPITAL assiut 71111 Egypt
Mohamed Abd El-Sattar AL- AZHAR SQUARE- ALAZHAR UNIVERSITY HOSPITAL assiut 71111 Egypt
A Abd El Mgeed AL- AZHAR SQUARE- ALAZHAR UNIVERSITY HOSPITAL assiut 71111 Egypt
Mohammad M. Abolfotouh AL- AZHAR SQUARE- ALAZHAR UNIVERSITY HOSPITAL assiut 71111 Egypt
AHMED A.M. NASR AL- AZHAR SQUARE- ALAZHAR UNIVERSITY HOSPITAL assiut 71111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AHMED NASR aam_nasr@yahoo.com 00201224204420 3 el tamin elsehy street
City Postal code Country Position/Affiliation
assiut 71111 Egypt lecturer of obstetrics and gynecology
Role Name Email Phone Street address
Public Enquiries Abd El-Naser Abd El-Gaber Ali nasrgaber81@rocketmail.com 00201062465599 el azhar square
City Postal code Country Position/Affiliation
assiut 71111 Egypt lecturer of obstetrics and gynecology
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abd El-Sattar noursatar@yahoo.com 00201006463553 al azhar university hospital
City Postal code Country Position/Affiliation
assiut 71111 Egypt
REPORTING
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