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.: PACTR201411000886127 Date of Approval: 13/09/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ovarian diathermy
Official scientific title Impact of unilateral vesus bilateral laparoscopic ovarian drilling on ovarian reserve and pregnancy rate: A randomized clinical trial
Brief summary describing the background and objectives of the trial To assess the impact of unilateral dose adjusted ovarian drilling compared to bilateral ovarian drilling on ovarian reserve and pregnancy rate.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Surgery,Treatment of polycystic ovary syndrome
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2014
Actual trial start date 01/10/2014
Anticipated date of last follow up 01/04/2015
Actual Last follow-up date 06/06/2015
Anticipated target sample size (number of participants) 108
Actual target sample size (number of participants) 108
Recruitment status Completed
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 unilateral drilling unilateral dose adjusted drilling of the larger ovary. The thermal dose received will be 60 Joules/cm3. 54
Experimental Group Bilateral drilling All patients received five punctures per ovary at 30Wfor 4 s each. Each ovary received 600 Joules, to give a total of 1200 Joules for both ovaries. 54
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
women with PCOS who were resistant to clomiphene citrate treatment Women with adrenal hyperplasia, thyroid disease, Cushing¿s syndrome, hyper-prolactinemia and a tumour-related excess of androgen were excluded from the study. 20 Year(s) 32 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 20/08/2014 Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom +2048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ovulation rate Ovarian ultrasound follow-up will be scheduled for Days2¿5of the menstrual cycle at 1, 3 and 6 months after LOD.
Primary Outcome Clinical pregnancy rate Clinical pregnancy rate at 1, 3 and 6 months after LOD.
Primary Outcome Ovarian reserve measures antral follicle count and Antimullerian hormone before LOD and at 3 months after LOD.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom +2048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom +2048 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine 25 Yasin Abd-Elghafar street Shibin Elkom +2048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Rezk Kafrmanawahla El-Bajour +2048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Rezk m_rezk9207@yahoo.com +201006237186 Kafr Manawahla
City Postal code Country Position/Affiliation
Elbajour +2048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
Role Name Email Phone Street address
Public Enquiries Hytham Hamza egysmart80@gmail.com +201001359136 Berket Alsabea
City Postal code Country Position/Affiliation
Berket Alsabea +2048 Egypt Lecturer of Obstetrics and Gynecology-Faculty of Medicine-Menoufia University
Role Name Email Phone Street address
Scientific Enquiries Tarek Sayyed tareksayed70@yahoo.com +201222739097 Nasr city
City Postal code Country Position/Affiliation
Cairo +202 Egypt Assistant Professor of Obstetrics and Gynecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information