Investigating the effect of iodine on the rate of apoptosis and proliferation in oocytes of infertile women with diminished ovarian reserve
Design
Type of study: semi-experimental before, after
Number: 10 patients with diminished ovarian reserve and candidates for frozen embryo storage
The study does not have randomization and each patient is compared to himself before and after receiving iodine
Settings and conduct
Location: Imam Khomeini Hospital, Tehran
Research steps include:
Selection of patients
Measurement of urine iodine
Stimulation of the ovaries with the antagonist protocol, puncture of the ovaries and collection of cumulus cells
Determining the quality of oocytes, evaluating PCNA gene expression of cumulus cells with real-time PCR and evaluating apoptosis with flowcytometry (before receiving iodofolic)
Receiving oral iodofolic containing 150 micrograms of iodine for two months
Re-stimulation of the ovaries in the second stage and repeating the above evaluations
Participants/Inclusion and exclusion criteria
Inclusion criteria
Ages between 25 to 42 years, Normal thyroid function with no history of thyroid disorders including hypothyroidism or hyperthyroidism, Absence of any underlying disease, antral follicle count between 3-5, AMH level between 1-0.1 (ng/mL) (based on Bologna criteria) (Ferraretti AP et al, 2014)
Exclusion criteria
Drug addiction, smoking, alcohol , presence of endometriosis , history of repeated miscarriages
Intervention groups
Infertile women with a diminished ovarian reserve who are candidate for embryo preservation will be evaluated for apoptosis and proliferation before and after two months of taking iodofolic tablets containing 150 micrograms of iodine.
Main outcome variables
Evaluation of the impact of iodine on the rate of apoptosis and proliferation of cumulus cells and its relationship with oocyte quality to enhance treatment success.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240819062811N1
Registration date:2024-09-07, 1403/06/17
Registration timing:registered_while_recruiting
Last update:2024-09-07, 1403/06/17
Update count:0
Registration date
2024-09-07, 1403/06/17
Registrant information
Name
Masoumeh Masoumi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
m_masoumi@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-31, 1403/06/10
Expected recruitment end date
2024-10-31, 1403/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of iodine on the rate of apoptosis and proliferation in oocytes of infertile women with diminished ovarian reserve
Public title
Investigating the effect of iodine on oocytes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages between 25 to 42 years, Normal thyroid function with no history of thyroid disorders including hypothyroidism or hyperthyroidism, Absence of any underlying disease, antral follicle count between 3-5, AMH level between 1-0.1 (ng/mL) (based on Bologna criteria) (Ferraretti AP et al, 2014)
Exclusion criteria:
Drug addiction, smoking, alcohol , presence of endometriosis , history of repeated miscarriages
Age
From 25 years old to 42 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
2
Oocyte samples of patients who are candidates for oocyte storage before and after receiving iodine
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Imam Khomeini Hospital Complex, end of Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2024-08-06, 1403/05/16
Ethics committee reference number
IR.TUMS.IKHC.REC.1403.206
Health conditions studied
1
Description of health condition studied
Infertile women with diminished ovarian reserve
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Apoptosis and proliferation of oocyte
Timepoint
The first stage before taking iodine and the second stage two months after taking iodine
Method of measurement
Apoptosis by flow cytometry and proliferation by real-time PCR
Secondary outcomes
empty
Intervention groups
1
Description
control group: Infertile women with a diminished ovarian reserve who are candidate for embryo preservation before taking iodofolic tablets. Intervention group: Infertile women with a diminished ovarian reserve who are candidate for embryo preservation after two months of taking iodofolic tablets of Dorsa Daro company containing 150 micrograms of iodine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Masoumeh Masoumi
Street address
Imam Khomeini Hospital, Waliasr Reproductive Health Research Center, end of Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Fax
+98 21 6658 1658
Email
masomeh_masomi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Keshavarz Boulevard, corner of Qods St., Tehran University of Medical Sciences, 6th floor, Research and Technology Vice-Chancellor
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 8163 3685
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Masoumi
Position
Research expert
Latest degree
Ph.D.
Other areas of specialty/work
Infertility
Street address
Imam Khomeini Hospital, Vali Asr Reproductive Health Research Center, end of Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Email
masomeh_masomi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Masoumi
Position
Research expert
Latest degree
Ph.D.
Other areas of specialty/work
Infertility
Street address
Imam Khomeini Hospital, Wali Asr Reproductive Health Research Center, end of Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Email
masomeh_masomi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Masoumi
Position
Research expert
Latest degree
Ph.D.
Other areas of specialty/work
Infertility
Street address
Imam Khomeini Hospital, Wali Asr Reproductive Health Research Center, end of Keshavarz Boulevard, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1616
Email
masomeh_masomi@yahoo.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
Sharing, if necessary, will be done after the end of the study.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available