Goal: Evaluation of changes in signaling pathway of Wnt/β-catenin in the endometrium of women with endometriosis after administration of vitamin D. If vitamin D can suppress this pathway in the endometrium of women with endometriosis it will be capable increase the rate of implantation after IVF in these patients. Inclusion criteria: 22-37 years old women with endometriosis. Exclusion criteria: The women that have received hormones or supplements in the last 6 months. Research design: Control grope consist of 14 women with healthy endometrium, half of them with deficiency of vitamin D and the other half without deficiency of vitamin D. All of them will undergo to biopsy of endometrium and aspiration of endometrial secretion in the mid-luteal phase. The endometriosis group consists of 33 women with endometriosis and deficiency of vitamin D, half of them will receive the routine treatment of endometriosis and 50000 IU vitamin D weekly for 12-14 weeks and the other half will receive only the routine treatment of endometriosis. All of them will undergo to biopsy of endometrium and aspiration of endometrial secretion in the mid-luteal phase before and after treatment. The rate of expression of some genes and proteins of the signaling pathway of Wnt/β-catenin will evaluate by ELIZA, RT-PCR and Western blot.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081823678N1
Registration date:2015-09-29, 1394/07/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-09-29, 1394/07/07
Registrant information
Name
Azar Paghohan
Name of organization / entity
Tehran University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3384 7169
Email address
a-paghohan@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical science
Expected recruitment start date
2015-12-10, 1394/09/19
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vitamin D3 on Wnt/β-catenin signaling pathway in the endometrium of women with endometriosis
Public title
The effects of vitamin D on endometriosis
Purpose
Basic scienece
Inclusion/Exclusion criteria
No usage of hormonal drugs, hormonal contraceptives, IUDs and supplements during the last 6 months; No history of pregnancy or lactation during the last 3 months; No contraindication of vitamin D; Age 22-37 years old; Body mass index between 18.5 to 30 kilograms per squer meter.
Age
From 22 years old to 37 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
47
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical science
Street address
Engelab
City
Tehran
Postal code
Approval date
2015-08-15, 1394/05/24
Ethics committee reference number
IR.TUMS.REC.1394.576
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80
ICD-10 code description
endometriosis
Primary outcomes
1
Description
experission of gene an protein of APC
Timepoint
before and three monthes after sampling
Method of measurement
western blot and RT-PCR
2
Description
experission of gene an protein of β-catenin
Timepoint
before and three monthes after sampling
Method of measurement
western blot and RT-PCR
3
Description
experission of gene an protein of DKK1
Timepoint
before and three monthes after sampling
Method of measurement
western blot and RT-PCR
4
Description
experission of gene an protein of DKK2
Timepoint
before and three monthes after sampling
Method of measurement
western blot and RT-PCR
5
Description
experission of gene an protein of WNT7
Timepoint
before and three monthes after sampling
Method of measurement
western blot and RT-PCR
6
Description
experission of gene an protein ofCD44
Timepoint
before and three monthes after sampling
Method of measurement
western blot and RT-PCR
7
Description
the activity of GSK-3b
Timepoint
before and three monthes after sampling
Method of measurement
western blot
8
Description
serum levels of 25(OH)D
Timepoint
before and three monthes after sampling
Method of measurement
Radioimmunoassay
Secondary outcomes
empty
Intervention groups
1
Description
Control group 1: consist of the endometrium of women with deficiency of vitamin D (the serum concentration of 25 hydroxy vitamin D 30 or lower than 30 nano grams per milliliter). No intervention will be done on this group.
Category
N/A
2
Description
Control group 2: consist of the endometrium of women with sufficiency of vitamin D (the serum concentration of 25 hydroxy vitamin D more than 30 nano grams per milliliter). No intervention will be done on this group.
Category
N/A
3
Description
endometriosis group 1: consist of the endometrium of women with endometriosis and deficiency of vitamin D (the serum concentration of 25 hydroxy vitamin D 30 or lower than 30 nano grams per milliliter). They will take 50000 IU vitamin D once weekly for 12-14 weeks. The endometrium secretion and tissue sampling will be done in the mid-secretory phase before and after the intervention.
Category
Treatment - Drugs
4
Description
endometriosis group 2: consist of the endometrium of women with endometriosis and deficiency of vitamin D (the serum concentration of 25 hydroxy vitamin D 30 or lower than 30 nano grams per milliliter). No intervention will be done on this group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Azar Paghohan
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran university of medical science
Full name of responsible person
Dr. aligoli Sobhani
Street address
faculty of medicin
City
Tehran
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 science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran university of medical science
Full name of responsible person
Azar Paghohan
Position
Phd student of reproductive biology
Other areas of specialty/work
Street address
faculty of medicine
City
Tehran
Postal code
Phone
+98 21 6641 9072
Fax
Email
a-paghohan@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of medical science
Full name of responsible person
Dr. Aligoli Sobhani
Position
Phd
Other areas of specialty/work
Street address
faculty of medicine
City
Tehran
Postal code
Phone
+98 21 6641 9072
Fax
Email
sobhania@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Azar paghohan
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)