The effect Dehydroepiandrosterone (DHEA) supplementation on IVF outcome
Design
A randomized clinical trial with parallel control group, double blind; Phase 2-3, on 70 patients; randomization is performed by using block randomization
Settings and conduct
Double-blind clinical trial in Fatemieh Hospital, Hamadan
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidates for IVF over 35 years,Body mass index between 18 and 25(kg/m^2),FSH hormone levels less than 10 IU / L
Exclusion criteria: Systemic diseases such as diabetes, thyroid diseases, History of ovarian surgery,History of receiving DHEA
Intervention groups
Taking dihydroepiandrosterone tablets, 25 mg three times a day for 8 weeks and in the control group, the same amount and duration of placebo are given.
Main outcome variables
Primary variables include clinical and chemical pregnancy rate, abortion rate, endometrial thickness and duration of ovarian stimulation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N14
Registration date:2021-04-05, 1400/01/16
Registration timing:prospective
Last update:2021-04-05, 1400/01/16
Update count:0
Registration date
2021-04-05, 1400/01/16
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-21, 1400/02/31
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect Dehydroepiandrosterone (DHEA) supplementation on IVF outcome
Public title
The effect Dehydroepiandrosterone (DHEA) supplementation on IVF outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for IVF over 35 years
Body mass index between 18 and 25 (kg/m^2)
FSH hormone levels less than 10 IU / L
Exclusion criteria:
Systemic diseases such as diabetes, thyroid diseases
History of ovarian surgery
History of receiving DHEA
Age
From 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the fact that the drug and placebo are indistinguishable in terms of shape and appearance, patients and the examining physician will not be aware of the type of drug treatment of the patient, so the study will be performed in a double-blind manner.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamdan
Province
Hamadan
Postal code
6517838695
Approval date
2021-02-27, 1399/12/09
Ethics committee reference number
IR.UMSHA.REC.1399.1036
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
Fourth week after intervention
Method of measurement
Based on Beta-HCG and ultrasound confirmation
2
Description
Chemical pregnancy rate
Timepoint
The second week after the intervention
Method of measurement
Based on Beta-HCG a confirmation
3
Description
Miscarriage rates
Timepoint
Before 6 and 20 weeks after the intervention
Method of measurement
File
4
Description
Endometrial thickness before embryo transfer
Timepoint
Before embryo transfer
Method of measurement
Using ultrasound
5
Description
Duration of stimulation
Timepoint
Time required for follicle growth
Method of measurement
Using ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Dehydroepiandrosterone pharmaceutical tablet manufacturing company Puritant`pride USA, 25 mg orally three times in 8 weeks before embryo transfer in patients undergoing IVF are given
Category
Treatment - Drugs
2
Description
Control group: Administration of placebo (starch tablets) three times a day for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemieh Hospital
Full name of responsible person
Soghra Rabiei
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
rabiei@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Soghra Rabiei
Position
Professor,
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamdan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
rabiei@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Soghra Rabiei
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
rabiei@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Somayeh Ahmadiani
Position
Gynecology Assistant
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Fatemieh Hospital, Pasdaran Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
rabiei@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD