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The Effect of Astaxanthin on the Expression of Genes Involved in Wnt /β-catenin Pathway in the Eutopic Endometrium and Inflammatory Factors Downstream of the NF-κB Pathway in the Serum of Women with Endometriosis Candidate for Assisted Reproductive Techniques

Protocol summary

Study aim
The Effect of Astaxanthin on Wnt/β-catenin Pathway Genes Expression in the Eutopic Endometrium and Inflammatory Factors Downstream NF-kB Pathway in the Serum of Endometriosis Patients Candidate for ART
Design
The current placebo-controlled RCT will follow guidelines contained in the Helsinki Declaration. After approval by the ethics committee of Tehran University of Medical Sciences (TUMS), 400 patients will be recruited. Before starting the intervention, written informed consent will be obtained from all participants.
Settings and conduct
Patient enrollment will be carried out at Omid Fertility Clinic. Lab tests (including ELISA to assess the inflammatory cytokines, Real-Time PCR to assess genes involved in the Wnt/ β-catenin pathway (β-catenin, GSK-3b, DKK-1, and WNT7a), and Western Blot to assess phosphorylated and phosphorylated β-catenin protein) will be performed in the Department of Anatomy, School of Medicine, Tehran University of Medical Sciences lab.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with infertility due to stage III or IV endometriosis confirmed by ultrasound, laparoscopy, or histopathological examination, 20 to 37 years old, 18.5 <BMI <30 kg / m2, having regular menstrual cycles, Do not take any hormonal drugs, hormonal contraceptives, supplements or IUDs from 3 months before the first biopsy, do not get pregnant or breastfeed from 3 months before the first biopsy, willing to participate in the study • Exclusion criteria: having autoimmune defects and cancer, diabetes, chronic infectious diseases, and any anatomical abnormalities in the uterine cavity such as fibroids and polyps, pregnancy, or taking hormones during intervention
Intervention groups
Astaxanthin and Placebo groups
Main outcome variables
Plasma inflammatory cytokines (IL-1β, IL-6, TNF-α) Genes in the Wnt/ β-catenin pathway Phosphorylated and phosphorylated β-catenin protein

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220625055274N1
Registration date: 2022-09-03, 1401/06/12
Registration timing: prospective

Last update: 2022-09-03, 1401/06/12
Update count: 0
Registration date
2022-09-03, 1401/06/12
Registrant information
Name
Sahar Rostami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3330 9531
Email address
rostami_shr91@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-03-19, 1401/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Astaxanthin on the Expression of Genes Involved in Wnt /β-catenin Pathway in the Eutopic Endometrium and Inflammatory Factors Downstream of the NF-κB Pathway in the Serum of Women with Endometriosis Candidate for Assisted Reproductive Techniques
Public title
The Effect of Astaxanthin on Endometriosis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with infertility due to endometriosis stage III or IV confirmed by ultrasound, laparoscopy, or histopathological examination 20 to 40 years old 18.5 < BMI <30 kg / m2 With regular menstrual cycles Not taking any hormonal medicine, hormonal contraception, or IUD for 3 months before the first biopsy No pregnancy or breastfeeding since 3 months before the first biopsy Willingness to participate in the study
Exclusion criteria:
Autoimmune defects, cancer, and diabetes Chronic infectious diseases Any anatomical abnormalities in the uterine cavity such as fibroids and polyps Pregnancy during the intervention Taking hormonal drugs during the intervention
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients presenting to the infertility clinic will be randomly assigned to the Astaxanthin or Placebo groups. Random allocation will be performed using the balanced block randomization method through block sizes of 4, such that an equal number is assigned to the Astaxanthin and Placebo groups.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This study will be a triple-blinded trial. The assignment will be hidden from participants, experimenters, and the data analyst. A person outside the study will assign the codes. The Astaxanthin and placebo packages, each containing 60 capsules, are exactly the same in terms of shape, color, size, and packaging. Drug bottles will be coded by a person outside the study, while the research team will be blinded to the bottle contents.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Deputy of Research and Ethics Committee of TUMS
Street address
Building No.1, Northern gate of Tehran University, Poursina St. Qods St. Enqelab St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-12-18, 1400/09/27
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1085

Health conditions studied

1

Description of health condition studied
Endometriosis
ICD-10 code
N80.9
ICD-10 code description
Endometriosis, unspecified

Primary outcomes

1

Description
Level of inflammatory cytokines, expression of Wnt/ β-catenin pathway genes (β-catenin, GSK-3b, DKK-1, and WNT7a), expression of phosphorylated and dephosphorylated β-catenin protein
Timepoint
Before and 12 weeks after the intervention
Method of measurement
ELISA, Real-Time PCR, Western Blot

Secondary outcomes

empty

Intervention groups

1

Description
Astaxanthin group: 1. Astaxanthin consumption: participants will take 6 mg of Astaxanthin daily (1 capsule containing 6 mg Astaxanthin) for 12 weeks.
Category
Treatment - Drugs

2

Description
Placebo group: Placebo consumption: participants will take 6 mg of Placebo daily (1 capsule containing 6 mg Placebo) for 12 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Omid Fertility Clinic
Full name of responsible person
Dr. Ashraf Alyasin
Street address
Building No. 87, Darvazeh Shemiran St., Baharestan St., Shahid Meshki St. (Fakhrabad), next to the Romanian Embassy, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 7767 0696
Email
omidivf@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Building No. 226, Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Email
tums_edu@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
Dr. Fardin Amidi
Position
Full Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Embryology Building (Building No. 4), Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6405 3411
Email
famidi@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Fardin Amidi
Position
Full professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Embryology Building (Building No. 4), Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6405 3411
Fax
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
Sahar Rostami
Position
Ph.D. candidate
Latest degree
Master
Other areas of specialty/work
Anatomy
Street address
Embryology Building (Building No. 4), Department of Anatomy, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6405 3404
Email
rostami_shr91@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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be published in valid and related scientific journals.
When the data will become available and for how long
2023
To whom data/document is available
Researchers working in academic institutions.
Under which criteria data/document could be used
The results can be used as adjuvant therapy in patients with endometriosis undergoing IVF/ICSI.
From where data/document is obtainable
Sahar Rostami
What processes are involved for a request to access data/document
Through email messages to the corresponding author.
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