Determination of the effect of pallidopin in preventing an early increase in LH in patients under IUI
Design
On the first or second day of meniscal cycle, patients underwent vaginal sonography to examine the follicle and thickness of the endometrium.
Otherwise, the level of LH and estradiol was measured and injected from the second day of menstruation for five days based on age and weight between 75 and 150 units of hMG injection.On day 6, ovulation stimulation was performed again by patients under vaginal ultrasonography in terms of number or size of folliclesIn the presence of at least two follicles 14 mm or higher, the nelfidipine tablet was administered to one group and another to another placebo.In the nausea diamine group, 30 mg tablets were taken three times a day for two days and sonography was performed again two days later.Hormone (RONAL-F) hMG and nelfidipine tablets continued until at least two 18 mm follicles were reached and ultrasound was performed every two days.n the presence of at least two 18 mm follicles, serum LH and serum estradiol levels were measured on the same day, and two hCG injections of the same day were injected at 5000 units and then IUI after 36 hours.in the case of LH Surge, when measured at least two 18 mm follicles, the serum level of LH measured was tripledSafety and side effects The IUI regimen was regularly controlled to respond to optimal treatment and IUI time.
Settings and conduct
Tehran Mahdieh Hospital
Participants/Inclusion and exclusion criteria
20<age<40
Having both healthy ovaries in biographies and ultrasound evaluation
Having at least one open tube in hysterosalpingography
Diagnosis of infertility and the choice of IUI treatment by a physician
Intervention groups
Those who had the criteria for entering the study and were candidates for IUI
Main outcome variables
LH serum
estrogen
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141223020408N6
Registration date:2018-08-12, 1397/05/21
Registration timing:retrospective
Last update:2018-08-12, 1397/05/21
Update count:0
Registration date
2018-08-12, 1397/05/21
Registrant information
Name
Robabeh Taheripanah
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2558
Email address
taheripanahf@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2018-03-05, 1396/12/14
Trial completion date
empty
Scientific title
Effect of Nimes Dopamine on prevention of early onset of LH in patients under IUI
Public title
The effect of Nimudipine on LH
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 20 to 40 years
Having both healthy ovaries in biographies and ultrasound assessment
Having at least one open tube in hysterosalpingography
تشخیص ناباروری و انتخاب روش درمانی IUI توسط پزشک معالج 59/5000Diagnosis of infertility and the choice of IUI treatment by a physician
Exclusion criteria:
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
46
Actual sample size reached:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Based on random numbers of numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
The investigator and the participants did not know how to get the drug and placebo
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofshahid beheshti University of Medical science
Street address
Tahrish hospital, Tajrish Ave
City
Tehran
Province
Tehran
Postal code
1653847955
Approval date
2018-01-14, 1396/10/24
Ethics committee reference number
IR.SBMU.MSP.RAC.1396.748
Health conditions studied
1
Description of health condition studied
INFERTILITI
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
prevention if LH surge
Timepoint
Before the intervention and the time of observation, at least two 18 mm follicles in ultrasound
Method of measurement
Blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: People who received Nimrodipine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh hospital
Full name of responsible person
Zahra razghandi
Street address
Shoosh Square- Fadaeian Eslam Ave
City
Tehran
Province
Tehran
Postal code
0
Phone
+98 21 5506 2628
Email
z.razghandi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
.
Street address
Velenjak-Tehran
City
Tehran
Province
Tehran
Postal code
.
Phone
+98 21 4378 2256
Email
z.razghandi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
.
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
زهرا رازقندی
Position
پزشک
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tajrish hospital Ave tajrish
City
Tehran
Province
Tehran
Postal code
1653847955
Phone
+98 21 2271 8005
Email
z.razghandi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Robabe taheripanah
Position
medicen
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tajrish hospital, Tajrish Ave
City
Tehran
Province
Tehran
Postal code
1653847955
Phone
+98 21 2271 8005
Email
taheripanahf@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Razghandi
Position
پزشک
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Tajrish hospital, Tajrish Ave
City
Tehran
Province
Tehran
Postal code
1653847955
Phone
+98 21 2271 8005
Email
z.razghandi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
,
When the data will become available and for how long
,
To whom data/document is available
,
Under which criteria data/document could be used
,
From where data/document is obtainable
,
What processes are involved for a request to access data/document