1. Home
  2. Approved trials
  3. » فارسی

The effect of selenium and vit E supplementation on anti-mullerian hormone (AMH) index and antral follicle count in infertile women with occult premature ovarian insufficiency: A randomized contorolled clinical trial

Protocol summary

Study aim
• Comparison of AMH concentration 12 months after initiation of intervention in the group receiving selenium and vitamin E and placebo group with control of the effect of AMH concentration before intervention • Comparison of the number of ovarian antral follicles 12 months after intervention in the group receiving selenium and vitamin E and placebo group with control of the effect of number of antral ovarian follicles before intervention • Comparison of ovarian volume 12 months after intervention in the group receiving selenium and vitamin E and placebo group with control of ovarian volume before intervention • Determining the frequency of adverse events in the treatment group for selenium and vitamin E recipients and the placebo group
Design
This is a randomized, controlled triple blinded with two arm parallel group clinical trial that have been designed for Occult POI patients referred to Al-Zahra clinic and clinics and clinics affiliated to Tabriz University of Medical Sciences. . The sample size is 35 in each grou
Settings and conduct
This is a randomized, controlled triple blinded with two arm parallel group clinical trial that have been designed for Occult POI patients referred to Al-Zahra clinic and clinics and clinics affiliated to Tabriz University of Medical Sciences.In this study, the participants and the person who performed the statistical analysis will be blinded
Participants/Inclusion and exclusion criteria
Entry Criteria: Accepting informed written consent Women aged 20 to 40 years old Menstrual cycle Having two ovaries There is no evidence of endocrine disorders (diabetes, thyroid disorders, Addison's disease, etc.) by asking the patient and checking out the results of previous patient tests. Occult POI (hormone AMH <1 ng / ml, reduced ovarian reserve, less than 5 anthral follicles, reduced ovarian volume to less than 2.5 cubic centimeters, or all three cases) With BMI <30, the weight and height in this study will be measured by the researcher and the BMI will be calculated according to the formula below. BMI = (WEIGHT (kg)) / (LENGTH (m ^ 2)) Non-arrival criteria: Drug Addiction and Tobacco Use Tend to use donation eggs Having evidence of OVERT POI (FSH> 15 or amenorrhea for more than 3 months) Supplementation of Selenium and Vitamin E three months before the onset of intervention Having a history of radiotherapy and chemotherapy Taking anticoagulants (co-administration of vitamin E with these drugs increases the risk of bleeding).
Intervention groups
The intervention group will receive Selenium pills and vitamin E for three months.The other group will receive the placebo of these two supplements. Because both (selenium and vitamin E) are the cofactor of the enzyme GPX, there is therefore no need for a separate group to check vitamin E or selenium alone
Main outcome variables
AMH concentration 12 months after intervention؛Number of antral follicles in ovarian 12 months after the intervention؛Volume of ovaries 12 months after intervention؛The incidence of side effects of selenium and vitamin E

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160410027311N6
Registration date: 2018-04-30, 1397/02/10
Registration timing: prospective

Last update: 2018-04-30, 1397/02/10
Update count: 0
Registration date
2018-04-30, 1397/02/10
Registrant information
Name
Behnaz Sadeghzadeh Oskouei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 0364
Email address
sadeghzadehb@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-04, 1397/02/14
Expected recruitment end date
2018-09-05, 1397/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of selenium and vit E supplementation on anti-mullerian hormone (AMH) index and antral follicle count in infertile women with occult premature ovarian insufficiency: A randomized contorolled clinical trial
Public title
The effect of selenium and vit E supplementation on Oogenesis improvement in infertile women with occult premature ovarian insufficiency: A randomized contorolled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Accepting informed written consent Women aged 20 to 40 years old Menstrual cycle Having two ovaries There is no evidence of endocrine disorders (diabetes, thyroid disorders, Addison's disease, etc.) by asking the patient and checking out the results of previous patient tests. Occult POI (hormone AMH <1 ng / ml, reduced ovarian reserve, less than 5 anthral follicles, reduced ovarian volume to less than 2.5 cubic centimeters, or all three cases) With BMI <30, the weight and height in this study will be measured by the researcher and the BMI will be calculated according to the formula below. BMI = (WEIGHT (kg)) / (LENGTH (m ^ 2))
Exclusion criteria:
Drug Addiction and Smoking The tendency to use donated eggs Having evidence of OVERT POI (FSH> 15 or amenorrhea for more than 3 months) Supplementation of selenium and vitamin E three months before the onset of intervention Having a history of radiotherapy and chemotherapy The use of anticoagulants (co-administration of vitamin E with these drugs increases the risk of bleeding)
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned 1 to 1 using the 4 and 6 block method right before the intervention begins.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Blinding the allocation by a non-trafficker is done in the sampling and the received intervention (drug or placebo) is placed in the numbered blank opaque glasses, thus identifying the placement of the individuals. Glasses will be numbered from 1 to 70. The first person will be given the number one glass, and this will continue until the end of the sampling.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Azadi St., Golghast St., Tabriz University of Medical Sciences, Central Building No. 2, Third Floor, Research Deputy Directorate
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-03-12, 1396/12/21
Ethics committee reference number
IR.TBZMED.REC.1396.1255

Health conditions studied

1

Description of health condition studied
occult premature ovarian insufficiency
ICD-10 code
E28.3
ICD-10 code description
Primary ovarian failure

Primary outcomes

1

Description
Concentration of anti-mullerian hormone (AMH)
Timepoint
Before the intervention begins and 12 months after the intervention begins
Method of measurement
To monitor the level of anti-mullerian hormone, blood sampling will be performed on the day of referral from the Brachial vein and will be immediately transferred to the laboratory and will be used with an ELISA kit.

2

Description
Number of ovarian antal follicles
Timepoint
Before the intervention begins and 12 months after the intervention begins
Method of measurement
Transvaginal ultrasonography of the ovary on the third day of the menstrual cycle, performed by a radiologist and a device for all participants to check the number of antral follicles.

Secondary outcomes

1

Description
Ovarian volume
Timepoint
Before the intervention begins and 12 months after the intervention begins
Method of measurement
Ovarian volume with the same ultrasound on the third day of menstruation using the following formula Ovarian volume = Length × height × width × π / 6 It will be calculated for each ovary separately

2

Description
The incidence of side effects of selenium and vitamin E and their placebo
Timepoint
After the end of the intervention
Method of measurement
The side effects of medicines will be questioned according to the checklist given during supplements or placebo and will be recorded in the checklist.

Intervention groups

1

Description
Intervention group: The intervention group will receive one tablet of selenium 200 micrograms daily and one vitamin E 400 units per day for 90 days.
Category
Treatment - Drugs

2

Description
Control group: The control group will receive the plasebo of Selenium and vitamin E for 90 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility Clinic of Al-Zahra Hospital
Full name of responsible person
Safiyeh Farhadi Dizaji
Street address
Alzahra Hospital , Artesh Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Fax
+98 41 3556 6449
Email
alzahrahospital@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Rashidi
Street address
Tabriz University of Medical Sciences, Golghasht St., Azadi St., Central Building No. 2, Third Floor, Department of Research Vice-Chancellery of Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4658
Email
Medical.librarian@chmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Safiyeh Farhadi Dizaji
Position
Midwifery Masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Midwifery Department, Nursing and Midwifery Faculty, South Shariati Street,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
s63farhadi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Behnaz Sadeghzadeh Oskouei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Faculty of Nursing & Midwifery, South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 0364
Fax
+98 41 3479 6969
Email
sadeghzadehb@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Safiyeh Farhadi Dizaji
Position
Midwifry masters student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
South Shariati St. - Faculty of Nursing and Midwifery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
s63farhadi@gmail.com

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
There is no program for publishing participant data file
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of the clinical study will be published as a article
When the data will become available and for how long
Immediately after publishing the results
To whom data/document is available
All researchers
Under which criteria data/document could be used
Scientific citation based on article
From where data/document is obtainable
email: sadeghzadehb@tbzmed.ac.ir
What processes are involved for a request to access data/document
Up to one week after comunication by email
Comments
Loading...