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.: PACTR201402000691997 Date of Approval: 29/10/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Hysteroscopy before first trial ICSI
Official scientific title Role of hysteroscopy before first trial ICSI: A prospective randomized controlled trial.
Brief summary describing the background and objectives of the trial Intrauterine pathologies are present in 25% of infertile patients. Structural abnormalities of the uterine endometrial cavity may affect the reproductive outcome adversely, by interfering with the implantation or causing spontaneous abortion. Intrauterine abnormalities may be visualized using variety of techniques. The advantage of hysteroscopy in the accuracy of the diagnosis of uterine cavity abnormalities that may cause or contribute to infertility has been shown by numerous studies.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Primary infertility
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/06/2013
Actual trial start date 01/06/2013
Anticipated date of last follow up 30/06/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants) 300
Recruitment status 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 =4) block size was fixed Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Hysteroscopy before first trial ICSI 150
Control Group No hysteroscopy 150
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
No previous IVF/ICSI cycle Antral follicle count (AFC) <4 Anti-mullarian hormone (AMH) <0.7 Detectable uterine pathology by ultrasound 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 01/05/2013 Medical Ethical Committee of Misrata National Center for infertility treatment
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 Implantation rate 24 day after ICSI
Secondary Outcome Abortion Any time during pregnancy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
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 treatment LISCO Company Village Kasr Ahmed Misrata Libyan Arab Jamahiriya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Misrata National Center for infertility treatment LISCO Company Village Kasr Ahmed Misrata Libyan Arab Jamahiriya Hospital
COLLABORATORS
Name Street address City Postal code Country
Ismail M. elfourteia LISCO Company Village Kasr Ahmed Misrata Libyan Arab Jamahiriya
Hassan Aly Hassan Elmaghraby 649 Horryia Avenue Janaklis Alexandria #402 Egypt
Asma Bashir Elkabir LISCO Company Village Kasr Ahmed Misrata Libyan Arab Jamahiriya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hassan Elmaghraby hassanmaghraby@gmail.com 002 01222137317 649 Horryia Avenue
City Postal code Country Position/Affiliation
Alexandria #402 Egypt Professor of Obstetrics and Gynaecology
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 Elmaghraby hassanmaghraby@gmail.com 002 01222137317 649 Horryia Avenue
City Postal code Country Position/Affiliation
Alexandria #402 Egypt Professor of Obstetrics and Gynaecology
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