Evaluating the effect of vitamin D treatment among patients with vitamin D deficiency on the outcome of IVF in poor responder IVF candidates; A clinical trial.
Determining and comparing the effect of vitamin D treatment in people with deficiency on the outcome of IVF in poor IVF women respondents in Akbarabadi Hospital
Design
A clinical trial with 2 intervention groups and 1 control group, with parallel groups was performed on 65 patients.
Settings and conduct
This study will be performed in Akbarabadi Women's Hospital in Tehran on mothers who are candidates for IVF-assisted reproductive therapy who have the necessary criteria. In this study, 2 intervention groups and 1 control group will be used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: • Maternal consent to perform diagnostic and laboratory procedures • Conscious consent to participate in this long-term study • Mother age between 20-40 years • According to the Poseidon criteria, the patient should be considered as a group 3 and 4 of Poor responder IVF mothers. Exclusion criteria: • Patient dissatisfaction with participation in the study • Existence of liver problems • Existence of cardiovascular problems • Endometriosis • Existence of kidney problems • Increase or decrease thyroid function • Hyperprolactinemia • BMI above 30 • BMI under 18
Intervention groups
Patients are classified into 3 groups: vitamin D deficiency (below 10 ng), inadequate vitamin D (between 11-30 ng), and patients with adequate vitamin D (above 30 ng). Patients with vitamin D deficiency and insufficient levels are treated with vitamin D. Vitamin D treatment is performed at 50,000 units per week, equivalent to 1250 micrograms of vitamin D for 6-8 weeks.
Main outcome variables
The results of the study are reported as the success rate of IVF as the main goal and the pregnancy rate as the secondary goal.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210820052235N1
Registration date:2022-06-06, 1401/03/16
Registration timing:prospective
Last update:2022-06-06, 1401/03/16
Update count:0
Registration date
2022-06-06, 1401/03/16
Registrant information
Name
Maryam Sadat Mirsharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5560 6034
Email address
dr_mirsharifi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of vitamin D treatment among patients with vitamin D deficiency on the outcome of IVF in poor responder IVF candidates; A clinical trial.
Public title
The effect of vitamin D on the outcome of IVF therapy in women with poor response to IVF treatment.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent of mother for diagnostic and laboratory measuressigning
Obtaining an informed consent form to participate in the study
Age between 20-40
Patients must be among group 3 or 4 of poor responder patients to IVF treatment, based on Poseidon criteria.
Exclusion criteria:
Lack of consent for contributing in the study
Any level of liver failure
Cardiovascular diseases
Endometriosis
Chronic kidney disease
Thyroid dysfunction
Hyperprolactinemia
BMI over 30
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
65
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat EXP.
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2022-01-30, 1400/11/10
Ethics committee reference number
IR.IUMS.FMD.REC.1400.600
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
The main result of the study is reported as IVF success rate
Timepoint
After childbirth
Method of measurement
Successful and failure rate of the pregnancy
2
Description
Pregnancy rate
Timepoint
16th weeks of pregnancy
Method of measurement
The number of pregnancies relative to the number of ovum transfer cycles
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Vitamin D deficient (Vitamin D level < 10 ng/dl). These patients will receive Pearl Vitamin D 50000 units per week for 6-8 weeks (Equal to 1250 micrograms weekly).
Category
Treatment - Drugs
2
Description
Control group: Sufficient vitamin D level (Vitamin D level > 30 ng/dl). These patients will receive Placebo just same as Pearl Vitamin D that would given to intervention groups per week for 6-8 weeks.
Category
Treatment - Drugs
3
Description
Intervention group: Vitamin D insufficient (Vitamin D level 10-30 ng/dl). These patients will receive Pearl Vitamin D 50000 units per week for 6-8 weeks (Equal to 1250 micrograms weekly).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbarabadi Hospital
Full name of responsible person
Maryam Sadat Mirsharifi
Street address
Molawi st.
City
Tehran
Province
Tehran
Postal code
4351411687
Phone
+98 21 5560 6034
Email
dr_mirsharifi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Sadat Mirsharifi
Street address
Molawi st.
City
Tehran
Province
Tehran
Postal code
4351411687
Phone
+98 21 5560 6034
Email
dr_mirsharifi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maryam Sadat Mirsharifi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Molawi st.
City
Tehran
Province
Tehran
Postal code
4351411687
Phone
+98 21 5560 6034
Email
dr_mirsharifi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Sadat Mirsharifi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Molawi st.
City
Tehran
Province
Tehran
Postal code
4351411687
Phone
+98 21 5560 6034
Email
dr_mirsharifi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Sadat Mirsharifi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Molawi st.
City
Tehran
Province
Tehran
Postal code
4351411687
Phone
+98 21 5560 6034
Email
dr_mirsharifi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data can be shared after deidentification.
When the data will become available and for how long
In 2024
To whom data/document is available
Researchers and GYN & OB Clinicians
Under which criteria data/document could be used
To make sure about the accuracy of the data and using them for research purposes.
From where data/document is obtainable
By sending an email to Dr. Maryam Sadat Mirsharifi: dr_mirsharifi@yahoo.com
What processes are involved for a request to access data/document
Within 72 hours from the request, we will respond to the request