The aim of this interventional study is to evaluate the efficacy of endometrial preparation with exogenous steroids, without pretreatment and with GnRH agonist in luteal cycle. A total of one hundred women who were undergoing frozen-thawed embryo transfer were enrolled in this study and randomly assigned into intervention or control group. In the control group, 60 patients receive GnRh agonist (buserelin) in the luteal phase while in the intervention group, consisting of 40 patients, GnRh agonist (buserelin) wasn’t administered in the luteal phase. The outcome of pregnancy will be compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109224572N2
Registration date:2011-10-17, 1390/07/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-10-17, 1390/07/25
Registrant information
Name
Shohreh Movahedi
Name of organization / entity
Infertility center,Shariati hospital,Tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 912 300 5195
Email address
shmovahedy@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Infertility Center, Shariati Hospital, Tehran University of Medical Sciences
Expected recruitment start date
2008-07-22, 1387/05/01
Expected recruitment end date
2009-04-21, 1388/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Endometrial preparation for frozen-thawed embryo transfer without gonadotropin releasing hormone agonist effect on the pregnancy results
Public title
Endometrial preparation for frozen-thawed embryo transfer with and without gonadotropin releasing hormone agonist
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of functioning ovary, normal cavity of uterus, age 25 to 38 years old, presence of infertility
Exclusion criteria: uterine anomaly, FSH more than 11, endometriosis, hypothalamic amenorrhea
Age
From 25 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Sciences
Street address
Enghelab Sq., Ghods st
City
Tehran
Postal code
Approval date
2011-06-11, 1390/03/21
Ethics committee reference number
90/123
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
pregnancy rate
Timepoint
pregnancy test was performed 15 days after transfer
Method of measurement
B HCG above 10 is considered positive
Secondary outcomes
empty
Intervention groups
1
Description
Control group : No intervention
Category
N/A
2
Description
Intervention group: the two cycles were cancelled, GnRh agonist (buserelin) wasn’t administered in the luteal phase
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center, Shariati Hospital, Tehran University of Medical Science,
Full name of responsible person
Infertility group
Street address
Shariati Educational, Research and Healthcare Center, the beginning of Jalal Al Ahmad High way
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Ale yasin
Street address
Shariati Educational, Research and Healthcare Center, the beginning of Jalal Al Ahmad High way
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
Shohre Movahedi
Position
Infertility fellow
Other areas of specialty/work
Street address
Baharloo Hospital, Tehran University of Medical Science, Iran
City
Tehran
Postal code
1645683583
Phone
+98 21556585004
Fax
+98 21 3327 2789
Email
shmovahedy@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shohre Movahedi M.D
Position
Infertilitys Fellowship
Other areas of specialty/work
Street address
Baharloo Hospital, Tehran University of Medical Science, Tehran ,Iran.
City
Tehran
Postal code
1645683583
Phone
+98 21556585004
Fax
+98 21 3327 2789
Email
shmovahedy@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)