comparison of the effect of cyclogess usage in vaginal or rectal form for luteal phase support on pregnancy rate of ICSI cycles and the rate of side effects and patients convenient in these two ways.
The object of this study is comparison of two usage form of Cyclogest suppository, rectal or vaginal on pregnancy rate in women who are candidate for intrcytoplasmic sperm injection (ICSI) and their side effects and patients convenient in these two ways. In this study 150 candidates for ICSI with long protocol enroll to study. Inclusion criteria are 20-37 years old age and first ICSI cycle. Exclusion criteria are women who have FSH>8ng/ml ,Hypotyroidy, hyperprolactinemia .On oocyte puncture day ,they allocate to two group randomly. in group 1 cyclogest suppositories administer vaginally 400 mg twice a day from oocyte puncture day for two weeks and in group 2 cyclogest suppositories administer rectally 400 mg from oocyte puncture day twice a day for two weeks and in two group 6 days after emberyo transfer the progesterone of serum will be evaluated and after two weeks biochemical pregnancy will be evaluated. The side effects and patients convenient in two groups will compare to each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807192568N1
Registration date:2011-04-20, 1390/01/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-04-20, 1390/01/31
Registrant information
Name
Haleh Rahmanpour
Name of organization / entity
Zanjan university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 241413003
Email address
haleh509@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Valiasre fertilityreaserch center,Tehran University of Medical Sciences
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effect of cyclogess usage in vaginal or rectal form for luteal phase support on pregnancy rate of ICSI cycles and the rate of side effects and patients convenient in these two ways.
Public title
Comparison of the effect and side effects of two way of progesterone suppository use in IVF cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are : 20-37 years old wemon candidate for first ICSI cycle
Exclusion criteria : FSH>8ng/ml ,Hypotyroidy,hyperprolactinemia
Age
From 20 years old to 37 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
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, Medicine faculty
Street address
Keshavarz bulovard ,ghods street ,tehran university of medical sciences
City
tehran
Postal code
Approval date
2011-01-21, 1389/11/01
Ethics committee reference number
874
Health conditions studied
1
Description of health condition studied
artificial fertilization
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
biochemical pregnancy
Timepoint
2 weeks after drug administration
Method of measurement
blood sample - BHCG
Secondary outcomes
1
Description
Perineal itching due to Cyclogest use in vaginal or rectal form
Timepoint
2 weeks after start of drug
Method of measurement
Ask of patients
2
Description
Vaginal discharge due to cyclogest use in vaginal and rectal form.
Timepoint
2 weeks after drug administration
Method of measurement
Ask of pationts
Intervention groups
1
Description
administeration of cyclogest suppository 400 mg twice a day in rectal form for intervention group
Category
Treatment - Drugs
2
Description
Administeration of cyclogest suppository 400 mg twice a day in vaginal form for control group
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasre hospital
Full name of responsible person
Dr haleh rahmanpour
Street address
Emam khomeini hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Valiasre reaserch center, Tehran university of medical sciences
Full name of responsible person
Dr Batool Hossein Rashidi
Street address
Valiasre hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Valiasre reaserch center, 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
Valiasre reaserch center
Full name of responsible person
Haleh Rahmanpour
Position
Obestetric and gynecologist
Other areas of specialty/work
Street address
Keshavarz boulevard ,Valiasre hospital
City
Tehran
Postal code
1419733141
Phone
+98 21 6658 1575
Fax
+98 21 6658 1658
Email
haleh509@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Valiasre reaserch center
Full name of responsible person
Haleh Rahmanpour
Position
Obestetric and gynecologist
Other areas of specialty/work
Street address
Keshavarz boulevard ,Valiasre hospital
City
Tehran
Postal code
1419733141
Phone
+98 21 6658 1575
Fax
+98 21 6658 1658
Email
haleh509@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Valiasre reaserch center
Full name of responsible person
Haleh Rahmanpour
Position
Obestetric and gynecologist
Other areas of specialty/work
Street address
Keshavarz boulevard ,Valiasre hospital
City
Tehran
Postal code
1419733141
Phone
+98 21 6658 1575
Fax
+98 21 6658 1658
Email
haleh509@zums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)