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.: PACTR201611001683280 Date of Approval: 14/06/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title personalized IVFto maximize success rate
Official scientific title individualized controlled ovarian stimulation for IVF to maximize success rate
Brief summary describing the background and objectives of the trial In the last two decades, pregnancy rates for patients undergoing in-vitro fertilization (IVF) have significantly increased. Some of the major advances responsible for this improvement were the introduction of controlled ovarian stimulation (COS) for the induction of multiple follicle development, and the utilization of midluteal gonadotropin-releasing hormone agonists to achieve pituitary down-regulation and full control of the cycle. As a result, a combination of a gonadotropin-releasing hormone agonist with high doses (150-450 IU/day) of recombinant follicle-stimulating hormone has become the current standard approach for ovarian stimulation. However, given the heterogeneity of patients embarking on IVF, and the fact that many different drugs can be used alone or in different combinations (generating multiple potential protocols of controlled ovarian stimulation), we consider the need to identify special populations of patients and adapt treatment protocols accordingly, and to implement a more individualized approach to COS.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied infertility,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female,Fertility-male
Purpose of the trial Treatment: Other
Anticipated trial start date 02/07/2016
Actual trial start date
Anticipated date of last follow up 02/10/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 500
Actual target sample size (number of participants) 500
Recruitment status Closed to recruitment,follow-up continuing
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control group Standardization ovarian stimulation 250 Active-Treatment of Control Group
Experimental Group Study group Individualized ovarian stimulation 250
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Age less than 39years. 2-Reguler menstrual cycle. 3-Both ovaries present. 4-NO history of ovarian surgery. 5-BMI ranje between 20-30kg/m2 6-NO history of endometriosis. 7-NO evidence of endocrine disorder. The only exclusion criterion was the prescence of ovarian cysts as assessed by by transvaginal ultrasound. Adult: 19 Year-44 Year 20 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 local ethical comitee of faculty of medicine
Ethics Committee Address
Street address City Postal code Country
minia university minia 61111 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome pregnancy rate 15 days after embryo transfer by serum pregnancy test (b-HCG)
Secondary Outcome secondary outcome correlation between follicular morphology and numbers to pregnancy rate
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
nile ivf centre korniche nile minia 61111 Egypt
mina infertility centre minia university minia 61111 Egypt
mina IVF infertility centre ebn khaseeb minia 61111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
minia university for scientific research aswan cairo agricultue road minia 61111 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor minia univesity minia 61111 Egypt University
Primary Sponsor minia university for scientific research aswan cairo agricultue road minia 61111 Egypt University
Primary Sponsor minia university for scientific research aswan cairo agricultue road minia 61111 Egypt University
COLLABORATORS
Name Street address City Postal code Country
nile ivf centre kornish elnile minia 61111 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hossam shawki hossam20002003@yahoo.com 00201223475856 shalbi
City Postal code Country Position/Affiliation
minia 61111 Egypt professor in university
Role Name Email Phone Street address
Public Enquiries saad elgaleny saad.elgelany@yahoo.co.uk 00201020372658 elgomhoryia
City Postal code Country Position/Affiliation
magagha-minia 61111 Egypt professor in university
Role Name Email Phone Street address
Scientific Enquiries kareem shahin drkareemelhadad@yahoo.com 00201003957442 horyia
City Postal code Country Position/Affiliation
minia 61111 Egypt asissant lecturer
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