Evaluation of the effects of Calcium- Vitamine D supplementary on ovulation and fertility outcomes of patients with poly cystic ovary syndrome
referring to Infertility Clinic of Imam Khomeini Hospital in 2011 and 2012 for in vitro fertilization
Through a randomized clinical trial, therapeutic impacts of calcium – vit D supplements are to be assessed on infertile women at pregnancy age (according to the Rotterdom Criteria) attending infertility clinic of Vali e Asr of Imam Khomeini Hospital. Inclusion Criteria are as abnormal menstrual cycles (oligomenorrhea or amenorrhea); Sonographically confirmed poly cystic ovary; Hyperandrogenism while the followings were considered as exclusion Criteria: Other medical conditions; Abdominal or pelvic surgeries; abnormal serum levels of Prolactin; Application of Induction- Ovulation methods within the past three months. One hundred consecutive patients will be randomly assigned to either group of receiving Calcium – D supplement (for three month) plus standard treatment or placebo group just receiving standard treatment. At the end of the treatment intervention, growing follicles, fetal grades, and pregnancy will be evaluated for each case and the results then compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112148408N1
Registration date:2012-08-17, 1391/05/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-17, 1391/05/27
Registrant information
Name
batool hossein rashidi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1658
Email address
mahdian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of Research, School of Medicine, Tehran University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of Calcium- Vitamine D supplementary on ovulation and fertility outcomes of patients with poly cystic ovary syndrome
referring to Infertility Clinic of Imam Khomeini Hospital in 2011 and 2012 for in vitro fertilization
Public title
Impcats of Calcium- Vitamine D supplementary on Ovulation in poly cystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Abnormal menstrual cycles (oligomenorrhea or amenorrhea); Sonographically confirmed poly cystic ovary; Hyperandrogenism
Exclusion Criteria: Other medical conditions; Abdominal or pelvic surgeries; abnormal serum levels of Prolactin; Application of Induction- Ovulation methods within the past three months
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Research Deputy, Faculty of Medicine, Poursina Street, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2013-05-05, 1392/02/15
Ethics committee reference number
54825/130/د/90
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Pregnancy
Timepoint
2 and 12 weeks
Method of measurement
Sonography and Biochemistry Laboratory
Secondary outcomes
empty
Intervention groups
1
Description
in control group they received placebo
Category
Treatment - Drugs
2
Description
In intervention group supplementary tablets of 1000 mg Calcium combined with 400 Iu vitamine D is Administered (Orally) twice a day for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Clinic of Vali Asr Hospital in Imam Khomeini Complex
Full name of responsible person
Dr batool hossein rashidi
Street address
Department of Obstetrics and Gynecology, Vali- e - Asr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blv
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Shahin Akhondzadeh
Street address
Medical School Research Affairs, Poorsina Street, Keshavarz Blv
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 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
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Mahdian
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Vali- e - Asr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blv
City
Tehran
Postal code
Phone
+98 21 6119 2382
Fax
Email
bhrashidi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Batool Hossein Rashidi
Position
professor of Ob& Gyn
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Vali- e - Asr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blv
City
Tehran
Postal code
Phone
+98 21 6119 2382
Fax
Email
mahdian@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azadeh Mahdian
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Vali- e - Asr Hospital, Imam Khomeini Hospital Complex, Keshavarz Blv
City
Tehran
Postal code
Phone
+98 21 6119 2382
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)