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.: PACTR202208677419951 Date of Approval: 10/08/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title STEM CELLS FOR OVARIAN REJUVENATION
Official scientific title OVARIAN REJUVENATION WITH AUTOLOGOUS ADIPOSE DERIVED STEM CELL THERAPY
Brief summary describing the background and objectives of the trial There appears to be an increasing prevalence of infertility related to diminished ovarian reserves in recent years. In the majority of cases, these women are of older age. However, in certain cases, a diminished ovarian reserve is diagnosed in much younger patients; an entity termed premature ovarian failure/insufficiency.A severely diminished ovarian reserve is one of the most devastating diagnosis regarding cause of infertility as for most women this would mean a very low likelihood of ovarian response to stimulation and hence low IVF success using their own oocytes. Most of these women will then have to resort to using donor oocytes. Due to the unacceptable nature of this intervention for some, many studies have been done to look at possible alternative treatments which may enable these women to use their own oocytes and hence afford them the opportunity to have a biological child of their own. Stem cells are one of these treatments which have been studied and have shown promising results. In the animal model, stem cell therapy to restore ovarian function has been encouraging.There are only a few human trials that have been conducted to evaluate the effects of stem cells therapy in the field of infertility.We propose a clinical study to determine if autologous adipose derived stem cells injected into the ovary of women with reduced ovarian reserves or premature ovarian failure can improve ovarian function, stimulate oocyte production and increase fertility potential.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) The SCORE trial
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: Other
Anticipated trial start date 02/09/2019
Actual trial start date 21/12/2020
Anticipated date of last follow up 31/03/2022
Actual Last follow-up date 31/03/2022
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants) 30
Recruitment status Completed
Publication URL https://journals.lww.com/grh/Fulltext/2023/03010/Use_of_autologous_adipose_derived_mesenchymal_stem.3.aspx
Secondary Ids Issuing authority/Trial register
5268 NHREC
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group stem cell therapy 0.5mls of SVF(stromal vascular fraction) 3 treatment sessions approximately 4 weeks apart SVF will be injected into each ovary transvaginally under ultrasound guidance 4 weekly (x3 doses) This will be done in a procedure room under conscious sedation and using aseptic technique 20
Control Group Placebo 0.5mls of placebo (saline) 4 weekly (3 doses) 0.5mls of placebo will be injected into each ovary transvaginally under ultrasound guidance. Procedure will take place under conscious sedation and using aseptic technique. 10 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Infertility patients with either premature ovarian failure diagnosed clinically and biochemically -Women with very low ovarian reserves diagnosed both biochemically with low AMH and radiologically with low AFC - history of current or previous malignancy - any other co-existing cause of infertility - inability to visualize the ovaries on transvaginal ultrasound - age >42 years - smoker Adult: 19 Year-44 Year 19 Year(s) 42 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 28/10/2020 Durban University of technology ethics committee
Ethics Committee Address
Street address City Postal code Country
41/43 M L Sultan road, Greyville Durban 4001 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1) hormonal biomarkers indicating recovery of ovarian function; (a decline in FSH and a rise in AMH) 2) resumption of menstruation in amenorrheic women AMH level will be checked 2 weekly and the AFC monthly prior to repeat intervention. Women with premature ovarian failure will also be asked to inform the unit should menstruation resume at any point
Secondary Outcome Response to ovarian stimulation with IVF, oocyte quantity obtained, embryo grading, euploidy rates and pregnancy outcomes Variable if proceeds onto doing IVF therapy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
BioART fertility centre 99 oxford road, Saxonwold Johannesburg 2196 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
BioART fertility clinic 99 Oxford Road, Saxonwold Johannesburg 2196 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor BioART 99 Oxford road, saxonwold Johannesburg 2196 South Africa Individual
Secondary Sponsor Next Biosciences Ariane Avenue, International business Gateway, cnr New Road and 6th Road, Midrand Johannesburg 1685 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Next Biosciences Ariane Avenue, International Business Gateway, Cnr New Road and 6Th Road, Midrand Johannesburg 1685 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tasneem Mohamed tm.mohamed@yahoo.com +27725355228 99 oxford road, Saxonwold
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa medical doctor specialist gynaecologist
Role Name Email Phone Street address
Public Enquiries Tasneem Mohamed tm.mohamed@yahoo.com +27725355228 99 Oxford road, Saxonwold
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa Medical doctor specialist gynaecologist
Role Name Email Phone Street address
Scientific Enquiries Mohamed Iqbal Cassim cassim@bioartfertility.co.za +27824412973 99 Oxford road, Saxonwold
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa fertility specialist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that is required for the results of the study. Participant anonymity will be maintained as all participant were provided a study number. Only the study number was used for communication between collaborators, and for statistical analysis. Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following date of publication Anyone who has an interest in the data and results of the study
URL Results Available Results Summary Result Posting Date First Journal Publication Date
ournals.lww.com/grh/Fulltext/2023/03010/Use_of_autologous_adipose_derived_mesenchymal_stem.3.aspx 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