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.: PACTR201706002330361 Date of Registration: 30/05/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ovarian Follicular Fluid Levels Of Vascular Endothelial Growth Factor (VEGF) In PCO Patients Undergoing Controlled Ovarian Hyperstimulation
Official scientific title Ovarian Follicular Fluid Levels Of Vascular Endothelial Growth Factor (VEGF) In PCO Patients Undergoing Controlled Ovarian Hyperstimulation
Brief summary describing the background and objectives of the trial This study is to determine the follicular fluid levels of vascular endothelial growth factor (VEGF) in PCOS patients and women with healthy ovaries all undergoing controlled ovarian hyperstimulation in preparation for IVF referred to the IVF center of Woman health center of the University of Assiut .
Type of trial CCT
Acronym (If the trial has an acronym then please provide) CSS
Disease(s) or condition(s) being studied Obstetrics and Gynecology,poly cystic ovary syndrome, PCOS
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 03/04/2017
Actual trial start date 01/06/2017
Anticipated date of last follow up 03/04/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Controlled ovarian hyperstimulation (COH) In PCO patients varable doses of gonadotrophins 10:14 days COH, drugs mainly gonadotrophins 45
Control Group Controlled ovarian hyperstimulation (COH) In women with healthy ovaries varable doses of gonadotrophins 10:14 days COH, drugs mainly gonadotrophins 45 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A-Inclusion criteria for all women: 1-Age between 20-38 years. 2-Adequate visualization of ovaries on transvaginal ultrasound. 3-No hormonal treatment. 4-women accepting participating the study with written informed consent obtained. B-Inclusion criteria for control women only (male factor infertility): 1-Normal ultrasonic ovarian morphology. 2-Normal ovulatory cycles. 3-No endocrine abnormalities. 1-Diminished ovarian reserve. 2-Concomitant Pelvic disorder like endometriosis, uterine fibroids, ovarian cysts. 3-women receiving hormonal treatment 3 months prior to the treatment. 4-Age more than 38y or less than 20y. 5-Women refusing to participate in the study. 6-Obese women, diabetic women. 20 Year(s) 38 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 03/04/2017 Assiut university
Ethics Committee Address
Street address City Postal code Country
El-gamaa st. assiut 71111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ovarian follicular fluid level of VEGF at the day of Ovum pick up (OPU)
Secondary Outcome Number of good quality embryos at day 3 or day 4 after fertilization
Secondary Outcome pregnancy rate serum pregnancy test done 14 days after embryo transfer
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assisted Reproductive unite at Assiut university hospital El-gamaa st. assiut 71111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
assiut university El-gamaa st. assiut 71111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor assiut university El-gamaa st. assiut 71111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Islam Mohammed Said El-Hekemdar St. assiut 71111 Egypt
Essam El-Din Mohamed Abd-Allah Khalifa El-Dokky Cairo 71111 Egypt
Hazem Saad El-Dein Mohammed Yosry Rageb St. assiut 71111 Egypt
Mansour Ahmed Mohamed Khalif El-Adly St. assiut 71111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Islam Said dr_alo10@hotmail.com 00201069222453 El-Hekemdar St.
City Postal code Country Position/Affiliation
Assiut 71111 Egypt Specialist of Gyn. and Obstetrics
Role Name Email Phone Street address
Public Enquiries Hazem Mohammed Hazemsaad2012@yahoo.com 01001028150 Yosry Rageb ST.
City Postal code Country Position/Affiliation
Assiut 71111 Egypt Prof. Gyn. and Obs. at Assiut U.
Role Name Email Phone Street address
Scientific Enquiries Esam Khalifa Ekart1@yahoo.com 01210131012 El-Dokky
City Postal code Country Position/Affiliation
Cairo 71111 Egypt Prof. Gyn. and Obs. at Assiut U.
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
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information