Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201911829230395 Date of Approval: 18/11/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ovarian Stimulation After Dehydroepiandrosterone Supplementation in Poor Ovarian Reserve
Official scientific title Ovarian Stimulation After Dehydroepiandrosterone Supplementation in Poor Ovarian Reserve
Brief summary describing the background and objectives of the trial Dehydroepiandrosterone (DHEA) is an essential pro-hormone in the ovarian follicular steroidogenesis. DHEA concentration declines progressively with age. The aim of this study is to improve fertility rates among infertile women with poor ovarian reserve seeking pregnancy.• Primary objective: To evaluate the effect of DHEA supplementation on ovarian reserve among females with poor ovarian reserve. Secondary objectives: To compare the outcomes of induction in both the study and the control groups, in which: 1. The number of mature follicles at time of ovulation. 2. The total dose of gonadotrophin stimulation needed for induction of ovulation. 3. The duration of ovarian stimulation. 4. E2 level at the day of hCG injection to assess the quantity and the quality of mature follicles.
Type of trial RCT
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 01/10/2016
Actual trial start date
Anticipated date of last follow up 01/10/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
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
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 Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group placebo group 2 continuous cycles 2 continuous cycles control group 25 Active-Treatment of Control Group
Experimental Group study group DHEA supplementation 25mg TID 2 continuous cycles study group 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Serum AMH <1.1 ng/ml 2. Serum FSH ≥10 mIU/L and ≤15 mIU/L on day 3 of cycle 3. Low antral follicle counts (AFC) ≤ 4 on Day 3 of cycle 1. Patients exposed to cytotoxic or radiotherapy for pelvic malignancies. 2. Patients on herbal or hormonal therapy. 3. Patients with cystectomy or oophorectomy. 4. Cases contraindicated to be supplemented with DHEA o Chronic kidney diseases, o Chronic liver diseases, o Diabetes, o Breast or Uterine cancers, o Endometriosis, o Fibroids, o Adrenal gland hyperplasia, o Psychological disorders like depression. 5. Hyperprolactinaemia. 6. Polycystic ovaries syndrome. 7. Severe male factor. Adult: 19 Year-44 Year 19 Year(s) 44 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 20/09/2016 research ethics committee faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
ring road kilo 4.5 ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate the effect of DHEA supplementation on ovarian reserve among females with poor ovarian reserve. after 3 cycles
Secondary Outcome To compare the outcomes of induction in both the study and the control groups, in which: 1. The number of mature follicles at time of ovulation. 2. The total dose of gonadotrophin stimulation needed for induction of ovulation. 3. The duration of ovarian stimulation. 4. E2 level at the day of hCG injection to assess the quantity and the quality of mature follicles. after 3 cycles
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine suez canal university ring road kilo 4.5 ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ola Mohamed Abdel Hamied Metawie ring road kilo 4.5 ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine suez canal university ring road kilo 4.5 ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ola Mohamed Abdel Hamied Metawie ring road kilo 4.5 ismailia Egypt
Magda Mostafa Elbely ring road kilo 4.5 ismailia Egypt
Eman Ahmed Fouad Kishk ring road kilo 4.5 ismailia Egypt
Mohamed ElPrince Adel ring road kilo 4.5 ismailia Egypt
omima tharwat taha ring road kilo 4.5 ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed elprince prince.ma939@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Public Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Scientific Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes sharing data will be through the published paper and after approval of ur research ethics committee Study Protocol after completion of the study after approval of our research ethics committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes • There was no significant difference between the two groups’ demographic data. • There was no significant difference between the two groups’ baseline investigations and that indicated good randomization of cases and control. • The study group showed a statistically significant difference between the baseline investigations before taking DHEA supplementation and after 2 months of taking the DHEA supplementation, the mean basal FSH decreased from 12.16±0.94 to 10.19±1.22 and that was statistically significant. The mean AMH level increased from 0.81±0.14 to 0.99±0.17 but it failed to reach significance level. The basal E2 level decreased from 32.20±5.50 to 21.48±5.84 and that was statistically significant. The mean Antral follicular count by U/S increased from 1.68±0.63 to 2.72±0.89 and that was statistically significant. • The comparison between the study group baseline investigations after 2 months of DHEA supplementation and the control group showed that the mean basal FSH of the study group was 10.19±1.22 compared with 11.94±1.11 in the control group, and that was statistically significant. The mean AMH level in the study group was 0.99±0.17 compared to 0.844±0.141 in the control group showed an improvement in the study group but it failed to reach significance level. The basal E2 level in the study group was 21.48±5.84 compared with 32.92±6.49 in the control group and that was statistically significant. The mean Antral follicular count by U/S in the study group was 2.72±0.89 compared to 1.88±0.73 in the control group and that was statistically significant. 20/10/2019 20/10/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.dropbox.com/s/26zaw9qq38za7e0/List%20of%20Tables%2C%20results.doc?dl=0
Changes to trial information