The purpose of this study is to evaluate luteal phase support on pregnancy rate in IUI cycles. In this study, 260 patients with infertility who are candidate for IUI will be enrolled. For all the patients, induction of ovulation is done with Clomiphen and HMG infusion and after IUI , They are randomized into two the following groups to receive progesterone, vaginal suppository, 400 mg, or placebo vaginal suppository for 14 days. After positive B-HCG, progestrone or placebo will be continued until 8th week of clinical pregnancy confirmed by detection of fetal heart rate in TVS. Outcomes of the study are biochemical pregnancy and clinical pregnancy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011165181N2
Registration date:2011-03-20, 1389/12/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-03-20, 1389/12/29
Registrant information
Name
Batool Rashidi
Name of organization / entity
Vali E Asr Reproductive Health Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9320
Email address
bhrashidi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Valiasr investigation center, Abooreihan Pharmaceutical Company
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2012-02-20, 1390/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of luteal phase support on pregnancy rate in IUI cycles, a double blind, placebo-controlled trial
Public title
Evaluation of luteal phase support on pregnancy rate in IUI cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age<35, duration of infertility less than 10 years, normal HSG and open tubes
Exclusion criteria: hypothalamic amenorrhea, FSH>10
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
260
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The ethics committee of TUMS research administration
Street address
Tehran University of Medical Sciences-Ghods Avenue-Keshavarz Blvd-Tehran -Iran
City
Tehran
Postal code
Approval date
2010-12-22, 1389/10/01
Ethics committee reference number
11421-39-03-89
Health conditions studied
1
Description of health condition studied
female infertility
ICD-10 code
N97
ICD-10 code description
Primary outcomes
1
Description
biochemical pregnancy
Timepoint
2 weeks after treatment
Method of measurement
BHCG in serum
Secondary outcomes
1
Description
clinical pregnancy
Timepoint
8 weeks of pregnancy
Method of measurement
detect of fetal heart rate with ultrasound
Intervention groups
1
Description
Progestron suppository, 400 mg daily, for 14 days
Category
Treatment - Drugs
2
Description
placebo suppository, daily, 14 dayes
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
valiasr hospital infertility clinic
Full name of responsible person
Dr Haleh Rahmanpour
Street address
Emam Khomeini hospital - Valiasr hospital
City
Tehran
2
Recruitment center
Name of recruitment center
Valiasr reproductive health center
Full name of responsible person
Dr Haleh Rahmanpour
Street address
Emam Khomeini hospital - Valiasr hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Chancellor for Research Of Tehran University of Medical Sciences
Full name of responsible person
Haleh Rahmanpoor
Street address
Building of Chancellor for Research Of Tehran University of Medical Sciences,Ghods Street ,Keshavarz Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chancellor for Research Of 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Valiasr research center
Full name of responsible person
Dr Batool Hossein Rashidi
Position
Obestetric & Gyn specialist and infertility feloship
Other areas of specialty/work
Street address
Valiasr hospital
City
Tehran
Postal code
Phone
+98 21 6693 9320
Fax
Email
bhrashidi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Dr Haleh Rahmanpour
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 21 6693 9320
Fax
Email
hale509@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)