Objectives: The aim of this study is to evaluate the effect of Vit D therapy on AMH level in infertile women older than 35 with deficient Vit D level; Design:30 patients suffering infertility with deficient Vit D level admitted in Firoozgar hospital in this before and after study will enroll.Sampling will be non randomized; Setting and conduct: Serum AMH level will measure before and 3 months after treatment with 50000 IU Vit D weekly for three months. Serum AMH level will compare with basal level after completion of treatment; Inclusion criteria : patients suffering infertility with insufficient Vit. D (lower than 30 ng/ml); Anti mullerian horman level less than 0.7 ng/ml.
Exclusion criteria :Vit Duse contraindication; Vit D use during 4 months before study; use of OCP during 2 months before study; thyroid function disorder; hyper prolactinemia; diabetes melituse; cogenital adrenal hyperplasia; Use of drugs affect on adrenal and ovarian function and metabolism of carbohydrates and lipids; Pregnancy; Intervention:Mothers with Vit D deficiency, 50000 IU of Pearl of Vit D weekly for three months administered; main outcome measures: Anti Mullerian Hormone Level before and three months after intervention, Fertility up to one year after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604137917N2
Registration date:2016-05-30, 1395/03/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-30, 1395/03/10
Registrant information
Name
Hamed Aghdam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3352 3126
Email address
h-aghdam@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Vit D therapy on anti-Mullerian hormone (AMH) level in women with infertility
Public title
Effect of Vit D therapy on anti-Mullerian hormone (AMH) level in women with infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : patients suffering infertility with insufficient Vit. D (lower than 30 ng/ml); Anti mullerian horman level less than 0.7 ng/ml.
Exclusion criteria :Vit Duse contraindication; Vit D use during 4 months before study; use of OCP during 2 months before study; thyroid function disorder; hyper prolactinemia; diabetes melituse; cogenital adrenal hyperplasia; Use of drugs affect on adrenal and ovarian function and metabolism of carbohydrates and lipids; Pregnancy.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Shahid Hemmat Highway,next to Milad Hospital
City
Tehran
Postal code
Approval date
2015-06-14, 1394/03/24
Ethics committee reference number
Ir.IUMS.REC.1394.9221290001
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Anti Mullerian Hormone Level
Timepoint
before and three months after intervention
Method of measurement
Hospital Labratoary
Secondary outcomes
1
Description
Fertility
Timepoint
up to one year after intervention
Method of measurement
Birth Report of the participants
Intervention groups
1
Description
Mothers with Vit D deficiency, 50000 IU of Pearl of Vit D producted in Zahravi Pharmaceutical Company weekly for three months administered.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Firoozgar hospital
Full name of responsible person
Leily Chenari
Street address
Beh Afarin Hospital, Valiasr Sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Abbas Motavallian, MD
Street address
Shahid Hemmat Highway,next to Milad Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
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
Iran University of Medical Sciences
Full name of responsible person
Zahra Naderi, MD
Position
OB & Gyn Specialist/ Assistant Professor
Other areas of specialty/work
Street address
OB & Gyn Ward of Firoozgar Hospital
City
Tehran
Postal code
Phone
+98 21 8214 1201
Fax
Email
naderi_gyn@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian, MD
Position
OB & Gyn Specialist/ Associated Professor
Other areas of specialty/work
Street address
OB & Gyn Ward of Firoozgar Hospital
City
Tehran
Postal code
Phone
+98 21 8214 1201
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
leili Chenari, MD
Position
OB & Gyn Resident
Other areas of specialty/work
Street address
OB & Gyn Ward of Firoozgar hospital
City
Tehran
Postal code
Phone
00
Fax
Email
leilichenari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)