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.: PACTR202112652853611 Date of Approval: 22/12/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect Of Serum HCG Levels And Follicular Fluid Fas Levels On ICSI Outcomes In Different Highly Purified HMG Stimulation Protocols
Official scientific title consecutive or concomitant hp-hMG with FSH; milder response but higher quality
Brief summary describing the background and objectives of the trial assess the effect of serum levels of human chorionic gonadotropin hormone (HCG) and follicular fluid soluble Fas levels on outcome of intra-cytoplasmic sperm injection (ICSI) cycles with two different human menopausal gonadotropins (HMG) stimulation protocols either consecutive or concomitant with FSH
Type of trial CCT
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 01/04/2020
Actual trial start date 13/04/2020
Anticipated date of last follow up 20/06/2021
Actual Last follow-up date 01/07/2021
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Completed
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 Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sequential protocol 150-300 IU gonadotropin daily 10-11 days 150-300 IU FSH daily till day 6 of treatment then 150 IU highly purified hMG 45
Control Group Concomitant protocol 150-300 IU daily gonadotropin 10 days 150-225 IU FSH plus 75 IU highly purified hMG till day 6 of treatment then from day 7 substitute 150-225 IU hp-hMG 55 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Women aged ≤ 37 years with expected normal response to the standard controlled ovarian stimulation undergo ICSI cycles, based on antral follicle count (AFC) and anti-mullerian hormone (AMH) level. - AMH level ≥ 1.2 ng/ml. - Women with history of poor ovarian response according to Bologna criteria. - Women with polycystic ovaries. Adult: 19 Year-44 Year 18 Year(s) 37 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 20/02/2020 Ethics committee of Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
17 Champlion st., El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Percentage of top quality embryos formation 3 or 5 days after oocyte retrieval
Secondary Outcome Serum HCG levels at day of triggering of ovulation. At day of trigger of ovulation
Secondary Outcome Follicular fluid levels of sFas. samples collected at day of oocyte retrieval, freezed at -80, then sFas measured at the end of the study
Secondary Outcome Number of metaphase (MII) oocytes. at day of oocyte retrieval
Secondary Outcome Incidence of OHSS. early till 9 days of trigger of ovulation. late OHSS 9 days before trigger
Secondary Outcome Clinical pregnancy rate 3- 4 weeks after embryo transfer
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dar El teb fertility center Ahmed Shawky street, Alex Sydney hospital Alexandria 21529 Egypt
Dar El Khousoba fertility center 1st Fawzy Moaz street Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
OLa Youssef Ahmed El-Shatby maternity university hospital, El-Geish road Alexandria 21526 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ola Youssef El-Geish road, Shatby University maternity hospital Alexandria Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ola Youssef olayoussef_n@hotmail.com +201006041870 El Shatby Maternity University hospital, El Geish Road
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant lecturer obstetrics and gynecology
Role Name Email Phone Street address
Public Enquiries OLa Youssef olayoussef_n@hotmail.com +201006041870 El Shatby Maternity University hospital, El-Geish Road
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant lecturer obstetrics and gynecology
Role Name Email Phone Street address
Scientific Enquiries Hassan Ali hassanmaghraby@gmail.com +201222137317 El Shatby Maternity University hospital, El-Geish Road
City Postal code Country Position/Affiliation
Alexandria Egypt Professor of obstetrics and gynecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes sharing of de-identified individual trial participant data. study protocol could be shared , it will be available for 24 months after publication. It will be shared whenever requested for purpose of meta-analysis Study Protocol 3 months after publication up to 24 months controlled, For individual participant metaanalysis
URL Results Available Results Summary Result Posting Date First Journal Publication Date
not available No
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