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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: www.pactr.org

Trial no.: PACTR201205000382185 Date registered: 2012/05/11
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
Purpose of the trial Treatment
Anticipated trial start date 2009-01-01
Actual trial start date 2009-02-15
Anticipated date of last follow up 2010-09-30
Actual date of last follow up 2010-12-31
Anticipated target sample size (number of participants) 80   
Actual target sample size (number of participants) 60   
Recruitment status Terminated
Secondary Ids Issuing authority/Trial register Links to Secondary ID

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

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

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max 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 Years 30 Years 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 2008/12/03 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 Fax
Public Enquiries Dr Abd El-Naser Abd El-Gaber Ali nasrgaber81@rocketmail.com 00201062465599
Street address City Postal code Country Position / Affiliation
el azhar square assiut 71111 Egypt lecturer of obstetrics and gynecology
Role Name Email Phone Fax
Principal Investigator Dr AHMED NASR aam_nasr@yahoo.com 00201224204420
Street address City Postal code Country Position / Affiliation
3 el tamin elsehy street assiut 71111 Egypt lecturer of obstetrics and gynecology
Role Name Email Phone Fax
Scientific Enquiries Dr Mohamed Abd El-Sattar noursatar@yahoo.com 00201006463553
Street address City Postal code Country Position / Affiliation
al azhar university hospital assiut 71111 Egypt