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.: PACTR201308000579176 Date of Approval: 04/07/2013
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Insulin sentizier for PCOS women undergoing ICSI
Official scientific title Pioglitazone hydrochloride in PCOS women undergoing ICSI with antagonist protocol: A Multicenter Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Androgen excess-PCOS Society Task Force defined PCOS by the presence of hyperandrogenism, ovarian dysfunction (oligo-anovulation and/or polycystic ovaries), and the exclusion of related disorders.  In PCOS treated with IVF/ICSI cycles, metformin exerts no clinical effect on rates of pregnancy or live birth.  Pioglitazone treatment in PCOS improves insulin action and decrease the androgen.  Further RCTs are needed to assess the effect of prior treatment with pioglitazone on results of ICSI.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine,Obstetrics and Gynecology,PCOS infertile women
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/09/2013
Actual trial start date 15/09/2013
Anticipated date of last follow up 14/09/2014
Actual Last follow-up date 14/09/2014
Anticipated target sample size (number of participants) 220
Actual target sample size (number of participants) 220
Recruitment status Not yet recruiting
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 Permuted block randomisation (block size of 4, not variable) Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Insulin Sensitizer 30 mg 30 days 30 mg of pioglitazone hydrochloride (Actos) daily orally starting from D2 of the previous cycle 110
Control Group Control 110 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients with PCSO as defined by Androgen excess-PCOS Society Task Force (2009) Diabetes Hypertension Intrauterine pathology Cholclate cyst Morbid obesity (BMI >35) 20 Year(s) 40 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 01/08/2013 Medical Ethical Committe of Misrata National Center for infertility Management
Ethics Committee Address
Street address City Postal code Country
LISCO Company Village Kasr Ahmed Misrata Libyan Arab Jamahiriya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical pregnancy with cardiac pulsation Four weeks after ICSI trial
Secondary Outcome Blastocyst formation Day 5 of ICSI
Secondary Outcome Ovarian hyperstimulation At any time after ovum pick up
Secondary Outcome Spontaneous miscarriage Up to 20 weeks pregnancy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shatby University Maternity Hospital PortSaid Street Alexandria Egypt
Alexandria IVF/ICSI Center 4 ElMoghadeen Street, Elhedia Alexandria Egypt
Misrata National Center for infertility treatment LISCO Company Village Kasr Ahmed Misrata Libyan Arab Jamahiriya
FUNDING SOURCES
Name of source Street address City Postal code Country
Misrata National Center for infertility Management LISCO Company Village - Kasr Ahmed Misrata Libyan Arab Jamahiriya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hassan Aly Hassan Elmeghraby 649 Horria Avenus, Janaklis Alexandria Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hassan Aly Hassan Elmeghraby 649 Horria Avenus, Janaklis Alexandria Egypt
Ismail M elfourteia LISCO Company Village - Kasr Ahmed Misrata Libyan Arab Jamahiriya
Yasser Saad Mohamed El Kassar Behind 122, Galal El Desoky street, Bab Sharq, Alexandria, Egypt. Alexandria Egypt
Zeneb Abulkassim Baayou LISCO Company Village - Kasr Ahmed Misrata Libyan Arab Jamahiriya
Ayman Ibrahim Milad Abudabbous LISCO Company Village - Kasr Ahmed Misrata Libyan Arab Jamahiriya
Dalal Elgizery 649 Horria Avenus, Janaklis Alexandria Libyan Arab Jamahiriya
Heba Hassan Aly Hassan Elmeghraby 649 Horria Avenus, Janaklis Alexandria Libyan Arab Jamahiriya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hassan Aly Hassan Elmaghraby hassanmaghraby@gmail.com 002 01222137317 649 Horryia Avenue
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Obstetrics and Gy
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria Egypt Patient Information Manager
Role Name Email Phone Street address
Scientific Enquiries Hassan Aly Hassan Elmaghraby hassanmaghraby@gmail.com 002 01222137317 649 Horryia Avenue
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of Obstetrics and Gy
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