Effect of astaxanthin on the expression of factors involved in mitophagy and mitochondrial biogenesis in ovarian granulosa cells of women with Polycystic ovary syndrome who are candidates for ART: a three-blind randomized controlled clinical trial
Effect of astaxanthin on the expression of factors involved in mitophagy and mitochondrial biogenesis in ovarian granulosa cells of women with Polycystic ovary syndrome who are candidates for ART
Design
A controlled, parallel-group, triple-blind, randomized, phase 3 clinical trial on 50 patients. The rand function of Excel software was used.
Settings and conduct
Diagnosis of PCOS based on the Rotterdam criteria and obtaining written informed consent from 50 participants
Control of drug and placebo consumption in patients for six weeks
Ovary stimulation and oocyte recovery and collection of granulosa cells and follicular fluid
Evaluation of MDA and TAC levels in follicular fluid
Evaluation of the expression of PINK1 and Parkin proteins in granulosa cells
Evaluation of expression of α-1PGC, SIRT-1 and TFAM in granulosa cells
Evaluation of mitochondria ultrastructure in granulosa cells
Evaluation of ART results
Statistic analysis
Place: Omid fertility clinic
Participants/Inclusion and exclusion criteria
Entry requirements:
Age range from 18 to 38 years
Body mass index (BMI) between 20 and 30
PCOS diagnosis based on the Rotterdam criteria and having at least two of the three criteria
Non-entry conditions:
pregnancy
Adrenal hyperplasia
Androgen-secreting tumors
Hyperprolactinemia
Thyroid dysfunction
diabetes
Infertility caused by male disorders
Taking antioxidant supplements up to six months before the start of the plan
Intervention groups
Astaxanthin group: daily use of 12 mg of astaxanthin for 25 eligible PCOS patients for 6 weeks. Control group: daily use of placebo for 25 eligible PCOS patients for 6 weeks.
Main outcome variables
Levels of TAC and MDA in follicular fluid; Expression levels of α-1PGC, SIRT-1, and TFAM in ranulosa cells; The expression level of PINK1 and Parkin proteins in granulosa cells; Ultrastructure of mitochondria in granulosa cells; outcomes of in vitro fertilization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231107059982N1
Registration date:2025-02-21, 1403/12/03
Registration timing:retrospective
Last update:2025-02-21, 1403/12/03
Update count:0
Registration date
2025-02-21, 1403/12/03
Registrant information
Name
Mahsa Motamed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4429 7504
Email address
m-motamed@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-23, 1402/10/02
Expected recruitment end date
2024-04-18, 1403/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of astaxanthin on the expression of factors involved in mitophagy and mitochondrial biogenesis in ovarian granulosa cells of women with Polycystic ovary syndrome who are candidates for ART: a three-blind randomized controlled clinical trial
Public title
Effect of astaxanthin on the expression of factors involved in mitophagy and mitochondrial biogenesis in ovarian granulosa cells of women with Polycystic ovary syndrome who are candidates for ART
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index (BMI) between 20 and 30
PCOS diagnosis based on the Rotterdam criteria and having at least two of the three criteria
Exclusion criteria:
pregnancy
Adrenal hyperplasia
Androgen secreting tumors
diabetes
Hyperprolactinemia
Thyroid dysfunction
Infertility caused by male disorders
Those who have taken antioxidant supplements, ovulation stimulating drugs, or drugs affecting the hormonal profile six months before starting the plan
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
3
Blood sample before the start of the intervention, blood sample after six weeks from the start of the intervention, ovarian follicular fluid sample obtained during the ovulation procedure.
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization was done by sealed envelope.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient receives the drug (intervention or placebo) in sealed envelopes that are coded. Coding is done by one of the collaborators of the project, and the doctor, the evaluator, the data analyst, and the patient are blinded.
Placebo
Used
Assignment
Parallel
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
Qods St., Central Building of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417863181
Approval date
2023-10-30, 1402/08/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.399
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Evaluation of expression of mitochondrial biogenesis pathway genes including Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α), Sirtuin 1 (SIRT1) and Mitochondrial transcription factor A (TFAM) in granulosa cells
Timepoint
End of study (end of intervention)
Method of measurement
Real time pcr method
2
Description
Evaluation of the expression of PTEN-induced putative protein kinase 1 (PINK1) and Parkin proteins in granulosa cells
Timepoint
End of study (end of intervention)
Method of measurement
Western blot method
3
Description
Levels of total antioxidant capacity (TAC) and Malondialdehyde (MDA) in follicular fluid
Timepoint
End of study (end of intervention)
Method of measurement
ELISA method
4
Description
outcomes of in vitro fertilization
Timepoint
End of study (end of intervention)
Method of measurement
Microscopic examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: daily intake of 12 mg of astaxanthin for 25 eligible patients with polycystic ovary syndrome for six weeks
Category
Treatment - Drugs
2
Description
Control group: daily use of placebo for 25 eligible polycystic ovary syndrome patients for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Fertility Clinic
Full name of responsible person
Dr. Hojjatullah Saidi
Street address
No. 87, Shahid Meshki St., Baharestan St., Darvazeh Shemiran St.
City
Tehran
Province
Tehran
Postal code
1998884349
Phone
+98 21 7767 0696
Email
info@omidfertility.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Ramin Kordi
Street address
Keshavarz Boulevard, at the corner of Qods Street, Central Administrative Building of the University, 6th Floor, Research and Technology Deputy.
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Email
vcr@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
Mahsa Motamed
Position
university student
Latest degree
Master
Other areas of specialty/work
Reproductive Biology
Street address
Porsina St., Tehran University of Medical Sciences, Faculty of Medicine, Anatomy Building, 2nd Floor
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 6640 5357
Email
Mahsa.motamed69@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fardin Amidi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Porsina St., Tehran University of Medical Sciences, Faculty of Medicine, Administrative Building, 3rd Floor, Financial Vice President of the University
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 6640 5357
Email
famidi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahsa Motamed
Position
University student
Latest degree
Master
Other areas of specialty/work
Reproductive Biology
Street address
Anatomy Building, Faculty of Medicine, Tehran University of Medical Sciences, Poorsina St.
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 6640 5357
Email
Mahsa.motamed69@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not 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