Investigating the effect of Turmeric tablet on serum and follicular fluid inflammatory and oxidative stress indicators in women with polycystic ovary syndrome undergoing infertility treatment
Determining the effect of turmeric tablets on inflammatory indices and oxidative stress of blood and follicular fluid of women with polycystic ovary syndrome undergoing infertility treatment.
Design
A clinical trial with one intervention groups and a control group, three blind strains, phase is conducted on 60 patients. For randomization, randomization is done through the quadruple block method and the block method using the seal envelope site.
Settings and conduct
Infertility Clinic of Akbar Abadi Hospital conducts randomization method on 60 patients. The intervention and placebo groups used 3 tablets of turmeric and placebo daily for 6 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Women undergoing IVF infertility treatment
- Iranian origin
- married
- Ages 18-40 years
Exclusion criteria:
1) Consumption of food and pharmaceutical supplements
2) Adhering to a special diet such as vegetarianism
3) Women with a history of infertility with simultaneous diagnosis of polycystic ovary syndrome and endometriosis
4) Hepatic and biliary disorders
5) under treatment with anticoagulant drugs
6) Active gastric ulcer
7) Having a history of allergy to turmeric or its products
8) Slimming diets
9) Athletes or special sports
Exit criteria:
-The occurrence of an allergy to turmeric during the study, which leads to discontinuation of the treatment as determined by a specialist doctor.
- Failure to take the medicine correctly for a maximum of two consecutive days or 3 alternate days per week
- Discontinuation of infertility treatment before puncture for any possible reason
Intervention groups
The intervention group used 3 tablets of 500 mg of turmeric daily for 6 weeks, and the placebo group used 3 tablets containing (placebo) daily.
Main outcome variables
inflammatory indicators, Oxidative stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100713004364N2
Registration date:2023-09-11, 1402/06/20
Registration timing:registered_while_recruiting
Last update:2023-09-11, 1402/06/20
Update count:0
Registration date
2023-09-11, 1402/06/20
Registrant information
Name
Leila Amini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3316 6574
Email address
amini@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-23, 1402/04/02
Expected recruitment end date
2024-09-23, 1403/07/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Turmeric tablet on serum and follicular fluid inflammatory and oxidative stress indicators in women with polycystic ovary syndrome undergoing infertility treatment
Public title
Investigating the effect of Turmeric tablet on serum and follicular fluid inflammatory and oxidative stress indicators in women with polycystic ovary syndrome undergoing infertility treatment
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Women undergoing IVF infertility treatment
Iranian origin
Ages 18-40 years
married
Body mass branch below 30 kg/m2
Exclusion criteria:
1) Consumption of food and pharmaceutical supplements
2) Adhering to a special diet such as vegetarianism
3) Women with a history of infertility with simultaneous diagnosis of polycystic ovary syndrome and endometriosis
4) Hepatic and biliary disorders
5) under treatment with anticoagulant drugs
6) Active gastric ulcer
7) Having a history of allergy to turmeric or its products
8) Slimming diets
9) Athletes or special sports
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A study is a three-blind randomized controlled trial in which the sampling will be continuous and the allocation of samples to the study groups will be random. Allocation of samples into two intervention and placebo groups will be done randomly and through the quadruple block method. The method of block classification is determined by someone other than the researcher using the seal envelope site, and the blocks are placed in opaque numbered envelopes.
Blinding (investigator's opinion)
Triple blinded
Blinding description
It is a three-blind randomization (researcher, people participating in the research, and a statistician).
Placebo
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 Sciece
Street address
Nursing & Midwifery faculty, Yasemi Ave, Valiasr St
City
Tehran
Province
Tehran
Postal code
۱۹۹۶۷۱۳۸۸۳
Approval date
2023-07-31, 1402/05/09
Ethics committee reference number
IR.IUMS.REC.1402.370
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
2
Description of health condition studied
Women Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
"Changes in inflammatory indices in women with polycystic ovary syndrome"
Timepoint
6 weeks after starting to take turmeric tablets
Method of measurement
Inflammatory indices in this study mean the measurement of C-reactive protein (in milligrams per liter), interleukin-6 (ELISA method) and the ratio of neutrophils to lymphocytes in the serum and follicular fluid of patients. IL-6: Interleukin 6 Human Platinum ELISA kit with ELISA method; It can be measured with a sensitivity of 0.92 pg/m and with a normal range of results: 1-100 pg/ml. CRP: Bionik CRP biochemistry kit made in Iran with photometric method and normal range of results: values up to 6 mg/L can be measured. Neutrophil to lymphocyte ratio: Sysmex model N-21KX machine is used for cell counting and to determine the percentage of neutrophils and lymphocytes, visual method or light microscope and Giemsa staining are used.
2
Description
and "Changes in oxidative stress indices in women with polycystic ovary syndrome"
Timepoint
6 weeks after starting to take turmeric tablets
Method of measurement
Oxidative stress indicators: Oxidative stress indicators in this research mean the measurement of malondialdehyde MDA (in micromolar per liter), total antioxidant capacity TAC and reactive oxygen radical ROS (milliunits per milliliter) in serum and follicular fluid of patients . MDA: It is measured using a 96-piece Well-plate kit made in Iran, Kia Biot Company, with a fluorimetric method that has a normal dynamic range: 20-100 µm. TAC: It is measured using a 96-piece Clean photometric plate well kit made in Iran, Kia Zeet company, with the Kuprak method, which has a dynamic range of 40-400 nmol/ml. ROS: It is measured by flow cytometry and fluorimetry using a kit of 96 Well Sterile Fluorimetric plates made in Iran, Kia Life Company. The fluorophore can be read at a wavelength of 525-485 Em/Ex=nm in plate fluorimetry or flow cytometry.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Turmeric tablet containing 450 mg of turmeric rhizome powder and 50 mg of turmeric extract, which is standardized by Dineh Pharmaceutical Company with drug registration number 7796008783541035, based on 5.47 mg of curcumin. 3 tablets are given daily to the internal group for 6 weeks.
Category
Prevention
2
Description
Control group: Placebo tablets containing 500 mg of maltodextrin are used 3 times a day by Dineh Pharmaceutical Company for 6 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Clinic of Shahid Akbarabadi Hospital
Full name of responsible person
Mahboubeh Karimi Majd
Street address
No. 31,Ghaem alley ,Ghaem Ave, Railway Town
City
tehran
Province
Tehran
Postal code
1494949553
Phone
+98 912 485 2172
Email
mahboubehkarimi78@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hossein Kiwani
Street address
Office of Vice President for International Affairs, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran 14496-14535, IRAN
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
info@iums.ac.ir
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
80
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
2
Sponsor
Name of organization / entity
Dineh Pharmaceutical Company of Iran
Full name of responsible person
Mahan Ebrahimi Qajar
Street address
No. 23, Shahid Jafarzadegan St., between Fasat and Nusrat, North Kargar St
City
Tehran
Province
Tehran
Postal code
1418813871
Phone
+98 21 6101 8021
Email
info@dinehiran.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dineh Pharmaceutical Company of Iran
Proportion provided by this source
5
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leila Amini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
pregnancy health
Street address
Rashid Yasmi St. above Vanak Square, Vali Asr St. (AJ)