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.: PACTR201604001553238 Date of Approval: 28/03/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Short term effect of Transvaginal Aspiration Of Immature Follicles Versus Laparoscopic ovarian Drilling for the managment of clomiphene citrate resis
Official scientific title Short term effect of Transvaginal Aspiration Of Immature Follicles Versus Laparoscopic ovarian Drilling for the managment of clomiphene citrate resistant PCO randomized case control studt
Brief summary describing the background and objectives of the trial this study will be conducted in Maternity hospital Minia University after getting approval from local ethical committee criteria for inclusion in the study patients with resistant PCOS all patients will prospectively randomized by computer generated number and divided into two groups group (1) study group transvaginal aspiration of immature follicles: 2-3 days postmenstrual with only IV sedation under tranvaginal us guide all peripheral follicles aspirated , group (2) control group Laparoscopic ovarian drill will be done according to the standard , protocol. both groups will be followed for first 6month first 3months without induction . criteria for follow up clinical improvement hormonal profile , ovulation and pregnancy rate
Type of trial RCT
Acronym (If the trial has an acronym then please provide) PODD
Disease(s) or condition(s) being studied ,Obstetrics and Gynecology,Surgery
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Surgery
Anticipated trial start date 10/04/2016
Actual trial start date 10/04/2016
Anticipated date of last follow up 16/10/2016
Actual Last follow-up date 16/10/2016
Anticipated target sample size (number of participants) 250
Actual target sample size (number of participants) 210
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
nil known Maternity Hospital Minia University
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 simple randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group transvaginal guided aspiration of immature follicles once 20- 40 minutes 2-3 days postmenstrual PCOS patient under fasting ,sedation needle aspiration of all immature follicle at the periphery of the ovary under transvaginal ultrasound guid 110
Control Group laparoscopic ovarian drilling once 30 45 miniutes laparoscopic ovarian drilling as standard guidlines 110
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all PCOS patients with clomiphene resistance age 18-35 patient approval patient refusaltubal other factors of infertility as proved by HSG and/or laparoscopy, uterine and cervical causes of infertility, history of ovarian surgery or pathology detected by TVS or any pelvic disease diagnosed at laparoscopy or diseases potentially affecting the ovarian environment and/or function including endomatriosis and leiomyomas and Male factor infertility. 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
No 02/04/2016 department of obstetrics and gynecology faculty of medicine Minia University ethical committee
Ethics Committee Address
Street address City Postal code Country
Minia University street Minia 61111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ovulation rate 3-6 months after intervention
Primary Outcome clinical improvement in the form of menstrual pattern 3-6 months post intervention
Secondary Outcome pregnancy rate 3-6 months post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Maternity hospital Minia University Minia University street Minia 61519 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Maternity Hospital Minia University Minia University street Minia 61111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Maternity Hospital Minia University Minia University street Minia 61111 Egypt Hospital
Primary Sponsor Maternity Hospital Minia University Minia University street Minia 61111 Egypt Hospital
Secondary Sponsor Minia University Minia University street Minia 61519 Egypt University
Secondary Sponsor Minia University Minia University street Minia 61519 Egypt University
Secondary Sponsor Minia University Minia University street Minia 61519 Egypt University
Secondary Sponsor Minia University Minia University street Minia 61519 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Reham elkateeb Taha Hussin Minia 61111 Egypt
hossam shawki shalabi street Minia 61111 Egypt
Ahmad Mahran shalabi street Minia 61111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hossam shawki hossam20002003@yahoo.com 0021223475856 Shalabi
City Postal code Country Position/Affiliation
Minia 61111 Egypt professor of obstetrics and gynecology
Role Name Email Phone Street address
Public Enquiries Reham Elkateeb rehamelkhateeb78@yahoo.com 00201011966648 Taha Hussin
City Postal code Country Position/Affiliation
Minia 61111 Egypt lecturer of Obstetrics and Gynecology
Role Name Email Phone Street address
Scientific Enquiries Ahmad Mahran ezzeldin_ahmad@yahoo.com 0021115551073 Shalabi
City Postal code Country Position/Affiliation
Minia 61111 Egypt lecturer of Obstetrics and Gynecology
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