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.: PACTR202007828853091 Date of Approval: 06/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title STEM CELLS FOR OVARIAN REJUVENATION (The SCORE trial)
Official scientific title OVARIAN REJUVENATION WITH AUTOLOGOUS ADIPOSE DERIVED STEM CELL THERAPY
Brief summary describing the background and objectives of the trial The diagnosis of a diminished ovarian reserve is devastating for women with infertility as this means a very low likelihood of ovarian response to stimulation and low IVF success rates using their own oocytes. Most of these women will then have to resort to using donor oocytes. Due to the reluctance of some to use donor oocytes, many studies have looked 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. Stem cells are one of these treatments which have been studied and have shown promising results.To date there is limited experience with stem cell therapy for ovarian rejuvenation in humans. Furthermore, the current trials have focused on bone marrow-derived stem cells and there are currently no trials analyzing adipose-derived stem cells (ADSC). This study aims 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. This is the first study investigating the ability of ADSC to promote ovarian function and facilitate fertility. The injection of stem cells into the ovary will be transvaginally via ultrasound guidance, under conscious sedation and hence minimally invasive. ADSC are easily and abundantly accessible unlike bone marrow-derived stem cells.This study will also include a placebo group which will allow for investigation of the effects of stem cells over and above the possible effects of ovarian puncture itself.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) 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 01/08/2020
Actual trial start date
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Autologous adipose derived stem cell insertion into ovary 0.5 mls of SVF( stromal vascular fraction) will be injected into each ovary transvaginally, under ultrasound guidance. This will be repeated monthly for 3 consecutive months. 3 months Autologous adipose derived stem cell therapy for ovarian rejuvenation 20
Control Group Placebo injection into ovary 0.5 mls of placebo solution injected into each ovary injections will be monthly for 3 consecutive months 3 months Placebo solution which looks exactly like the SVF will be injected into each ovary transvaginally under ultrasound guidance 10 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Infertile women with either premature ovarian failure diagnosed clinically and biochemically - Infertile women with very low ovarian reserves diagnosed both biochemically with low AMH and radiologically with low AFC - Eligible women must consent to partake in the study - A history of current or previous malignancy - Any other co-existing cause of infertility in the couple (male or female factors) - The 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 21/10/2019 Durban University of Technology
Ethics Committee Address
Street address City Postal code Country
Steve Biko 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 3) response to ovarian stimulation, oocyte quantity obtained, embryo grading, euploidy rates and pregnancy outcome AMH will be checked 2 weekly. FSH monthly. Resumption of menses in amenorrheic women at any point in study. Response to ovarian stimulation etc- at time of IVF. Pregnancy outcome 10 days post transfer
Secondary Outcome 1) to determine the optimal concentration of stem cells to be used 2) to determine the effects of ovarian perfusion on stem cell grafting 3) to determine the ideal patient candidate who is likely to benefit from stem cell therapy. Secondary outcome measures will be determined after data has been collected and through secondary analysis of the data.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
BioART Fertility Clinic 99 Oxford Road Johannesburg 2196 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Oxford road day clinic 99 Oxford Road, Saxonwold Johannesburg 2196 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Oxford road Day clinic 99 Oxford road Johannesburg 2196 South Africa Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Dr Tasneem Mohamed 99 Oxford Road Johannesburg 2196 South Africa
Jamila Kathoon Adam 41/43 M L Sultan Road, Greyville Durban 4001 South Africa
Dr Yusuf Dasoo 99 Oxford road Johannesburg 2196 South Africa
Carola Niesler 238 Mazisi Kunene Road, Glenwood Durban 4041 South Africa
Thoko Nhlabathi 99 Oxford Road Johannesburg 2196 South Africa
Jethro Hundling International Business Gateway Cnr New Road and 6th Road, Midrand Johannesburg 1685 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Iqbal Cassim cassim@bioartfertility.co.za +27114845168 99 Oxford Road
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa Fertility Specialist
Role Name Email Phone Street address
Public Enquiries Jamila Kathoon Adam adamjk@dut.ac.za +27827860682 41/43 ML Sultan Road, Greyville
City Postal code Country Position/Affiliation
Durban 4001 South Africa Supervisor
Role Name Email Phone Street address
Scientific Enquiries Tasneem Mohamed tm.mohamed@yahoo.com +27725355228 99 Oxford Road
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa Medical doctor Gynaecologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All data ill be recorded and updated as the trial progresses. Our records will include information from the initial assessment, how the patient was recruited, eligibility criteria etc. It will then include specific information about the treatment protocol and the monitoring of treatment i.e. ultrasound findings, blood results etc. Our recordings will also allow provision for the monitoring of any adverse events. All our data will be captured in such a way that no identifying details will be used so as to maintain the anonymity of the participants. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol The study protocol and consent forms are available immediately. The statistical analysis report and the study report will be available within 12 months from the completion of the study. Results of the study may be requested by any party. However requests to view the actual data and the statistical analysis thereof will need to be specifically requested by any concerned party. Requests are to be made by email and will be considered on a case by case basis. All requests will be complied with as long as its within reason and as long as the reason for the request and the interests of the requesting person/s are transparent.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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