Comparison of the effectiveness of melatonin supplementation with placebo on oxidative and inflammatory stress markers in infertile couples with unknown cause.
Determining the effect of melatonin supplementation on oxidative and inflammatory stress markers in infertile couples with unknown cause
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, phase 3 on 84 patients, randomization based on patient file number
Settings and conduct
All infertile women aged 18 to 42 and their spouses who are infertile couples with an unknown cause refer to Yasouj infertility clinic and will be candidates for intrauterine sperm insemination (IUI). Patients in the placebo control group and patients in the control group will receive melatonin at a dose of 6 mg every night for 2 months from the beginning of the IUI cycle to the end of the IUI cycle. Antioxidant levels will be measured before and after the study in both groups. became. The patients will be randomly divided into two control and control groups, and the patients will receive melatonin in the control group and placebo in the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria include all infertile women aged 18 to 42 and their spouses who are infertile couples with an unknown cause without uterine and sperm abnormalities and underlying diseases. Exclusion criteria include the patient's unwillingness and the occurrence of complications during the study.
Intervention groups
Patients in the placebo control group and patients in the control group will receive melatonin at a dose of 6 mg every night for 2 months from the beginning of the IUI cycle to the end of the IUI cycle. Antioxidant levels will be measured before and after the study in both groups. became.
Main outcome variables
Determination and comparison of CRP levels; TNF-α; SOD; CAT; GPS; MDA; PCO; FRAP; NO and melatonin in infertile couples before and after the study
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240415061493N1
Registration date:2024-04-29, 1403/02/10
Registration timing:registered_while_recruiting
Last update:2024-04-29, 1403/02/10
Update count:0
Registration date
2024-04-29, 1403/02/10
Registrant information
Name
Nastaran Golmohamadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3355 4772
Email address
nastaran.golmohamadi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of melatonin supplementation with placebo on oxidative and inflammatory stress markers in infertile couples with unknown cause.
Public title
Evaluation of melatonin supplementation on infertile couples
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of uterine and tubal anomalies in women and absence of genital anomalies and varicocele in men.
Absence of underlying disease in couples
Absence of smoking, tobacco, drugs and alcohol in couples
Body mass index (BMI) less than 35 in women
Normal sperm analysis
Normal hysterosalpingography (HSG) of the lady
Ovary storage suitable for women
Not taking antioxidant drugs
Exclusion criteria:
Cause a complication during the study for the patient
Unwillingness to continue cooperation of the patient
Age
From 18 years old to 42 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Infertile couples will receive all the information related to the study, and then the patients will be divided into two control and control groups, and then the patients will receive melatonin in the control group and placebo in the control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Plate number 3, 17 ave., moalem 2 Blvd
City
Rasht
Province
Guilan
Postal code
4336100000
Approval date
2024-03-13, 1402/12/23
Ethics committee reference number
IR.YUMS.REC.1402.182
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
1- Determination and comparison of the amount of TNF-α in infertile couples with an unknown cause receiving melatonin supplementation compared to the control group before and after the study 2- Determination and comparison of the CRP level in infertile couples with an unknown cause receiving melatonin supplementation compared to the group Control before and after the study 3- Determine and compare the level of SOD activity in infertile couples with an unknown cause receiving melatonin supplements compared to the control group before and after the study 4- Determine and compare the level of CAT activity in infertile couples with an unknown cause receiving Melatonin supplementation compared to the control group before and after the study 5- Determining and comparing the level of GPX activity in infertile couples with an unknown cause receiving melatonin supplementation compared to the control group before and after the study 6- Determining and comparing the MDA level in infertile couples with an unknown cause receiving melatonin supplements compared to the control group before and after the study.7- Determining and comparing the amount of protein carbonyl (PCO) in infertile couples with an unknown cause receiving melatonin supplements compared to the control group before and after the study.8- Determining and comparing the total antioxidant capacity of plasma (FRAP) in infertile couples with an unknown cause receiving melatonin supplements compared to the control group before and after the study.9- Determining and comparing the amount of nitric oxide (NO) metabolites in infertile couples with an unknown cause receiving melatonin supplements compared to the control group before and after the study. 10- Determining and comparing the amount of melatonin in infertile couples with an unknown cause receiving melatonin supplements compared to the control group before and after the study.11- Determining the rate of pregnancy success after IUI in infertile couples with an unknown cause receiving melatonin supplements compared to the control group.
Timepoint
Before and after starting the antioxidant melatonin
Method of measurement
Oxidative stress indices will be measured using special kits. The analysis of melatonin will be done using a high-performance liquid chromatography device equipped with an ultraviolet-visible detector at a certain wavelength and a 125 cm long separation column.
Secondary outcomes
1
Description
Determining the rate of pregnancy success after IUI in infertile couples with an unknown cause receiving melatonin supplements compared to the control group.
Timepoint
After completing the study
Method of measurement
bhcg measurement, vaginal sonography at 7 weeks, no pregnancy loss until 20 weeks
Intervention groups
1
Description
Intervention group: Melatonin will be prescribed for two months in the form of 6 mg every night from the beginning of the cycle of the month before IUI to the end of the IUI cycle.
Category
Treatment - Drugs
2
Description
Control group: Control group: Placebo pill containing cellulose, which is similar to melatonin pill in terms of shape, size and taste, will be prescribed for two months in the form of 6 mg every night from the beginning of the cycle of the month before IUI to the end of the IUI cycle.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sajad Hospital
Full name of responsible person
Shahintaj Aramesh
Street address
2th floor, Golestan 10, Artesh Ave,
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7578100000
Phone
+98 74 3322 3983
Email
shahin.aramesh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyed Amin Hossaini Motlagh
Street address
Social Determinants of Health Research center, Yasuj University of Medical Science, Motahari Blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7578100000
Phone
+98 74 3334 6078
Email
aminhomo@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Nastaran Golmohamadi
Position
Residency
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
2th moalem,17 ave, house number 3
City
Rasht
Province
Guilan
Postal code
4153884985
Phone
+98 13 3355 4772
Fax
Email
nastaran.golmohamadi@yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Nastaran Golmohamadi
Position
Residency
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
2th moalem,17 ave, house number 3
City
Rasht
Province
Guilan
Postal code
4153884985
Phone
+98 13 3355 4772
Fax
Email
nastaran.golmohamadi@yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Nastaran Golmohamadi
Position
Residency
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
2th moalem,17 ave, house number 3
City
Rasht
Province
Guilan
Postal code
4153884985
Phone
+98 13 3355 4772
Fax
Email
nastaran.golmohamadi@yums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information on the main outcome is shared.
When the data will become available and for how long
6 months after the publication of the results
To whom data/document is available
Researchers of academic institutions
Under which criteria data/document could be used
Scientific researchers who have a similar study or their research should be present in the continuation of the study
From where data/document is obtainable
Scientific researcher of the study
What processes are involved for a request to access data/document
Sending an email to the scientific researcher of the study, the reason for the need for research documentation, review and maximum response within one month