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.: PACTR201702002035137 Date of Approval: 13/02/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound-guided transvaginal ovarian needle drilling
Official scientific title Impact of Ultrasound-guided transvaginal ovarian needle drilling versus 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 Ultrasound-guided transvaginal ovarian needle drilling versus laparoscopic 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,Pregnancy and Childbirth,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 01/03/2017
Actual trial start date 18/02/2017
Anticipated date of last follow up 01/08/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 240
Actual target sample size (number of participants) 240
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Transvaginal needle drilling, TND once once undergo NTD using a 16-gauge, 35-cm long sharp needle connected to a continuous manual vacuum pressure. Each ovary will be repeatedly punctured from different angles with between three and six punctures. 120
Experimental Group Laparoscopic ovarian drilling once once will undergo LOD. All patients received five punctures per ovary at 30 W for 4 seconds each. 120
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Diagnosis of PCOS was based on the revised Rotterdam criteria, CC resistance , A normal semen analysis, normal uterine cavity and bilateral tubal patency . Patients with FSH >15 mIU/ml, medical disorders as diabetes mellitus and hypertension, contraindications for laparoscopy, endocrine disorders: hyperprolactinemia (prolactin >22 ng/dl), thyroid disorders, cushing¿s syndrome, and acromegaly and patients having organic pelvic disease as well as husband semen abnormalities (severe oligospermia) 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 09/02/2017 Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ovulation rate ovarian ultrasound follow-up will be scheduled for days 2¿5of the menstrual cycle at 3 and 6 months after the procedure.
Primary Outcome Clinical pregnancy rate following spontaneous conception at 3 and 6 months after the procedure.
Primary Outcome Ovarian reserve measures antral follicle count (AFC) and anti- Mullerian hormone (AMH) before the procedure and at 3 and 6 months after the procedure.
Secondary Outcome adverse effects adverse effects of the procedure
Secondary Outcome patient acceptability patient acceptability
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia University hospital 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine,Menoufia University 25 Yasin Abd-Elghafar street Shibin Elkom 002048 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 002048 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Rezk 25 Yasin Abd-Elghafar street Shibin Elkom 002048 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Assistant Professor of Obstetrics and Gynecology
Role Name Email Phone Street address
Public Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Assistant Professor of Obstetrics and Gynecology
Role Name Email Phone Street address
Scientific Enquiries Mohamed Rezk m_rezk9207@yahoo.com 00201006237186 25 Yasin Abdelghafar street
City Postal code Country Position/Affiliation
Shibin Elkom 002048 Egypt Assistant Professor of Obstetrics and Gynecology
REPORTING
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Changes to trial information