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.: PACTR201601001394393 Date of Approval: 17/12/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparative study between 2 methods of clomid administration in treatment of patient with clomid resistant PCOS
Official scientific title Long term use of clomiphene citrate in induction of ovulation in PCO patients with clomiphene citrate resistance
Brief summary describing the background and objectives of the trial The aim of the present study was to determine the effect of long (extended) use of CC for induction of ovulation versus traditional therapy in resistant PCOS and to evaluate the effects on serum FSH and LH with respect to changes in menstrual pattern , ovulation rate and pregnancy rate after treatment. This prospective controlled study will recruit One hundred women with PCOS from the attendants of the Gynecology clinic at El-Minia University Hospital . conducted in the department of Obstetrics and Gynecology , Faculty of Medicine , Minia University , from September 2015 to February 2016 after being accepted by department committee . These patients will be divided into two groups: ¿ Control group: Include 100 patients with PCOS will receive 150mg once daily starting from 2nd day of cycle for five days for 3 successive cycle . ¿ Study group: Include another 100 patients with PCOS will receive 150 mg clomiphene citrate once daily orally for 10 days starting from 2nd day of the cycle and this was repeated for 3 successive cycles .Comparison between the different groups as regard the clinical characteristics and hormonal levels before and after treatment . . All patients in the control and study groups will be followed up for a period of 3 months post ¿ treatment . Menstrual pattern , ovulation rate and pregnancy rate .The recruited woman will subjected to: ¿ History taking, ¿ General examination, ¿ Local pelvic examination, ¿ TVUS examination to document ultra ¿ sound criteria of PCOS, ¿ Blood samples were obtained from each patient in the control and study groups and FSH , LH were measured . The recruited woman will subjected to: ¿ History taking, ¿ General examination, ¿ Local pelvic examination, ¿ Trans ¿ vaginal ultra ¿ sound examination to document ultra ¿ sound criteria of PCOS, ¿ Blood samples were obtained from each patient in the control and study groups and FSH , LH were measurement
Type of trial RCT
Acronym (If the trial has an acronym then please provide) prospective comparat
Disease(s) or condition(s) being studied ,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 08/09/2015
Actual trial start date 17/09/2015
Anticipated date of last follow up 17/02/2015
Actual Last follow-up date 20/02/2015
Anticipated target sample size (number of participants) 250
Actual target sample size (number of participants) 200
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised sealed opaque envelopes containing random generated numbers Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group treatment 150 10 days clomiphene citrate adminsteration 100
Control Group treatment 150 5 days clomiphene citrate adminsteration 100 Historical
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Age : ranges from (18-35 years) . 2. 1st , 2 rd infertility due to PCO 3. PCOS was diagnosed with at least 2 PCO criteria (according to ESHRE criteria 2004 ):- a- U/S scanning (Necklace appearance). b- Anovulation : clinically diagnosed as oligomenorrhea / amenorrhea . c- Hyperandrogenism 4. Ovarian dysfunction will be the only cause of infertility after exclusion of other infertility causes . 1. Other factors causing infertility 2. Surgically removed or congenitally absent both ovaries 3. Abnormal ovarian pathology (cyst or mass).. ¿ Extensive pelvic adhesions , or extreme obesity interfering with ultrasound visualization of ovaries 18 Year(s) 35 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 03/09/2015 Obstetrics and Gynecology of maternity hospital Minia university
Ethics Committee Address
Street address City Postal code Country
Minia 6111 Egypt
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 01/09/2015 minia university faculty of medicine
Ethics Committee Address
Street address City Postal code Country
university street Minia 61111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ovulation rate , pregnancy rate ovulation rate in treatment cycle cumulative pregnancy rate over 3 moth
Secondary Outcome hormonal changes before treatment and after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minia University Minia 6111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
faculty of medicine Minia 6111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minia Maternity Hospital Minia 2151 Egypt Hospital
Secondary Sponsor Minia University Minia 6111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Reham elkateeb Taha Hussin Minia 5111 Egypt
Ahmad Ezzeldin Shalabi Minia 5111 Egypt
Hani Hassan shalabi street Minia 5111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Reham Elkateeb rehamelkhateeb78@yahoo.com 0021011966648 Taha Hussin
City Postal code Country Position/Affiliation
Minia Egypt lecturer
Role Name Email Phone Street address
Public Enquiries Hany Hassan hanyhassan1973@yahoo.com 00201001204427 shalabi street
City Postal code Country Position/Affiliation
Minia 5111 Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries Ahmad Mahran ezzeldin_ahmad@yahoo.com 00201115551073 Shalabi
City Postal code Country Position/Affiliation
Minia Egypt lecturer
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information