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.: PACTR201604001567272 Date of Approval: 05/04/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title IVF outcome after laparoscopic ovarian drilling
Official scientific title IVF outcome after laparoscopic ovarian drilling: case controlled trial
Brief summary describing the background and objectives of the trial we will try to study effect of LOD on ICSI-ET cycles and supposed that it may be beneficial or not
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 01/01/2015
Actual trial start date 01/01/2015
Anticipated date of last follow up 01/01/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants)
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 Simple randomisation using a radomisation table created by a computer software program Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ICSI ET one cycle one month ICSI_ET post LOD 100
Control Group ICSI not preceded by LOD one cycle one month ICSI_ET 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age 19-39years no endometriosis no severe male factor azzospermic endometriosis POR 19 Year(s) 39 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 01/04/2016 CUH ethical committee
Ethics Committee Address
Street address City Postal code Country
kasrainy St Cairo 11555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clinical pregnancy rate 6 weeks gestation
Secondary Outcome no of mature oocyte at day of OPU
Secondary Outcome No of GI embryos day 3 post ICSI
Secondary Outcome total gonadotropin dose and duration at day of HCG
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ART unit of Cairo University Hoapiata(CUH) kasralainy st Cairo 11555 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
CUH kasralainy Cairo 11555 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CUH kasralainy Cairo 11555 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Hala Abd elwahab Abd el latif 33 matebaa st , alharam Cairo 12613 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Adel Nada adel.nada29@gmail.com +201111765934 24 abdelrahman albarkoky -almanyal
City Postal code Country Position/Affiliation
Cairo 11555 Egypt Cairo University
Role Name Email Phone Street address
Public Enquiries Hala Elemedy Fawzy.Jana@Yahoo.com 01002412549 160 King Faisal st
City Postal code Country Position/Affiliation
Giza 12613 Egypt Cairo University
Role Name Email Phone Street address
Scientific Enquiries Hala Abdelatif Hala_wahab20022002@yahoo.com Mobile 01015777887 33 matebaa st , alharam
City Postal code Country Position/Affiliation
Giza 12613 Egypt Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial type 23/12/2016 Modified CCT RCT
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial phase 05/07/2018 pactr update Not Applicable
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Purpose of the trial 05/07/2018 pactr update Treatment: Other Treatment: Drugs
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated trial start date 10/05/2017 new information 2016-04-10 2015-01-01
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 06/04/2016 it is just spelling mistake 2016-10-10 2016-04-10
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 10/05/2017 new information 2016-04-10 2015-01-01
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 10/05/2017 new information 2016-11-10 2017-01-01
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 17/12/2016 after sample size calculation 60 200
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation to intervention 23/12/2016 add information Non-randomised Randomised
Section Name Field Name Date Reason Old Value Updated Value
Study Design Allocation sequence 23/12/2016 add information Simple randomisation using a radomisation table created by a computer software program
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Disease(s) 23/12/2016 add information ART ART
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Sub disease(s) 05/07/2018 pactr update Fertility-female