Protocol summary

Summary
Vitamin D deficiency can reduce fertility, impair neonatal growth and superimpose to preeclampsia. Inclusion criteria: The patients who received standard long protocol for ivf. Exclusion criteria: FSH>10. A prospective cohort study was undertaken at Yazd research and clinical center for infertility. One hundred eighty infertile women undergoing IVF were referred to this center between September 2010 and September 2011.All the patients received long protocol as starting OCP from the second day of menstruation and suprefact 1mg/day after consumption of 15 pills of OCP.After menstruation suprefact decreased to .25 mg/day and it is continued till the day of ovum pick up.Gonadotropin is initiated from the second day of menses. When follicular size is reached to 18-20 mm, HCG 10000 IU is recommended .After 34-36 hours ovum picks up is performed. In the day of ovum pick up, follicular fluid and serum are collected for assay of vitamin D. Samples are frozen at -80 ºC and after all samples were gathered ,vitamin D is assayed. After that Vitamin D will be compared between pregnant and no pregnant groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201107314339N3
Registration date: 2011-08-09, 1390/05/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-08-09, 1390/05/18
Registrant information
Name
Elham Rahmani
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77125265914
Email address
rahmani@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd research and clinical center for infertility
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Predictive value of follicular fluid Vitamin D in pregnancy rate of ivf program
Public title
The effect of vitamin D in succss of IVF
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: The patients who received standard long protocol for ivf, FSH<10, age between 20 till 39. Exclusion criteria: The patients who received other protocol for ivf, FSH>10, Age<20, age >39, liver disease, kidney disease, heart disease.
Age
From 20 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Yazd research and clinical center for infertility
Street address
yazd-boali street- research and clinical center for infertility
City
Yazd
Postal code
8916877391
Approval date
2011-05-24, 1390/03/03
Ethics committee reference number
646

Health conditions studied

1

Description of health condition studied
female infertility
ICD-10 code
N97
ICD-10 code description
female infertility

Primary outcomes

1

Description
Chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
serum BHCG

Secondary outcomes

1

Description
Vitamin D of serum and follicular fluid
Timepoint
The day of ovum retrival
Method of measurement
Vitamin D of serum and follicular fluid

Intervention groups

1

Description
All the patients received long protocol as starting OCP from the second day of menstruation and suprefact 1mg/day after consumption of 15 pills of OCP.After menstruation suprefact decreased to .25 mg/day and it is continued till the day of ovum pick up.Gonadotropin is initiated from the second day of menses. When follicular size is reached to 18-20 mm, HCG 10000 IU is recommended .After 34-36 hours ovum picks up is performed. In the day of ovum pick up, follicular fluid and serum are collected for assay of vitamin D. Samples are frozen at -80 ºC and after all samples were gathered ,vitamin D is assayed. After that Vitamin D will be compared between pregnant and no pregnant groups.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd research and clinical center for infertility
Full name of responsible person
Dr. Elham Rahmani
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd.
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr. Razieh Dehghani Firoozabadi
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd.
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd research and clinical center for infertility
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
Yazd research and clinical center for infertility
Full name of responsible person
Dr.Elham Rahmani
Position
Obestetrics and Gynecologist
Other areas of specialty/work
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd.
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
rahmani@bpums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr Razieh Dehghani Firoozabadi
Position
obestetrics and gynecologist-fellowship of infertility
Other areas of specialty/work
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd.
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
dr_firouzabadi@ssu.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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