Comparing the effects of adding Vagifem and vaginal Premarin in increasing endometrial thickness and pregnancy rate in IVF patients whose endometrial thickness was not responsive to conventional regimens, in Shiraz.
We will study the effect of vaginal premarin (Estromarin vaginal cream, 2.5 mg, Aburaihan pharmaceutical, Iran) and vagifem (vaginal tablet, 10 mcg, Novo Nordisk, Denmark) on endometrial thickness and embryo implantation in women with failure to achieve optimal endometrial thickness in IVF embryo transfer cycle with conventional estrogen therapy. This is a randomized clinical trial which will be conducted in Shiraz, Iran. Using computer generated block randomization method, 60 women in reproductive age are divided into two groups. Exclusion criteria is women aged less than 24 or more than 42; previous history of tuberculosis; Asherman syndrome or collagen vascular diseases. Also, smokers and alcohol abusers. The patients will receive vaginal Premarin cream 1.25 mg/ day (half of vaginal applicator) and vagifem, one tablet Bid (20 micrograms) is added to previous estrogen regimen. While being checked for endometrial thickness responsiveness. The endometrial thickness, and chemical (positive beta-HCG test with ELISA) and clinical pregnancy (detection of intrauterine sac by vaginal sonography) will be compared in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012102911306N1
Registration date:2013-03-21, 1392/01/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-03-21, 1392/01/01
Registrant information
Name
Hossein Haghbin
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1648 6731
Email address
haghbinh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research; Infertility Research Center, Shiraz University of Medical Sciences
Expected recruitment start date
2013-05-31, 1392/03/10
Expected recruitment end date
2013-11-29, 1392/09/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of adding Vagifem and vaginal Premarin in increasing endometrial thickness and pregnancy rate in IVF patients whose endometrial thickness was not responsive to conventional regimens, in Shiraz.
Public title
Vagifem and vaginal Premarin in pregnancy rate in IVF patients whose endometrial thickness was not responsive
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with failure to achieve optimal endometrial thickness in IVF embryo transfer cycle with conventional estrogen therapy.
Exclusion criteria: women aged less than 24 or more than 42; previous history of tuberculosis; Asherman syndrome or collagen vascular diseases; smokers and alcohol abusers.
Age
From 24 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
8th Floor, main building of Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Postal code
713451978
Approval date
2012-12-04, 1391/09/14
Ethics committee reference number
CT-p-91-4238
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
The largest longitudinal endometrial thickness in fundal area
Timepoint
Before intervention and every few days
Method of measurement
Vaginal ultrasonography
Secondary outcomes
1
Description
Pregnancy rate
Timepoint
Two weeks after embryo transfer
Method of measurement
Measuring level of blood BhCG by ELISA
2
Description
Clinical pregnancy
Timepoint
Four weeks after embryo transfer
Method of measurement
Detecting of intrauterine sac by vaginal sonography
Intervention groups
1
Description
women with failure to achieve optimal endometrial thickness in IVF embryo transfer cycle with conventional estrogen therapy are divided to study groups. In group 1, vagifem, 1 tablet Bid (20 micrograms) is added to previous estrogen regimen.
Category
Treatment - Drugs
2
Description
women with failure to achieve optimal endometrial thickness in IVF embryo transfer cycle with conventional estrogen therapy are divided to study groups. In group 2, Premarin cream 1.25 mg/ day (half of vaginal applicator) is added to estrogen regimen.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Research Center
Full name of responsible person
Street address
4th Floor, Ghadir Hospital, Ghoran Avenue
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research;Shiraz University of Medical Sciences
Full name of responsible person
Gholam Reza Hatam
Street address
8th Floor, main building of Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
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;Shiraz 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
Infertility Research Center
Full name of responsible person
Hossein Haghbin
Position
Medical student
Other areas of specialty/work
Street address
Infertility Research Center, 4th Floor, Ghadir Hospital, Ghoran Avenue
City
Shiraz
Postal code
Phone
+98 71 1648 6731
Fax
Email
hoshaq@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Infertility Research Center
Full name of responsible person
Nasrin Dadras
Position
fellowship of infertility
Other areas of specialty/work
Street address
Infertility Research Center, 4th Floor, Ghadir Hospital, Ghoran Avenue
City
Shiraz
Postal code
Phone
+98 71 1646 2610
Fax
Email
dadras.nasrin@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Infertility Research Center
Full name of responsible person
Hossein Haghbin
Position
Medical student
Other areas of specialty/work
Street address
Infertility Research Center, 4th Floor, Ghadir Hospital, Ghoran Avenue
City
Shiraz
Postal code
Phone
+98 71 1648 6731
Fax
Email
hoshaq@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)