The aim of this study is to investigate the efficacy of Luteal phase support with intravaginal progesterone in women undergoing controlled ovarian stimulation combined with Intrauterine insemination. In this single blinded clinical trial, 196 consecutively seen women candidate for IUI and divided to case and control groups.Case and control group consisted of 99 and 97 patients, respectively matched for age and implicating factor of infertility.The case group received intravaginal progesterone (400mg daily for 10 days starting from the day after IUI, while control group received no additional medication. blood samples were collected and serum progesterone level in 7th and 11th day after IUI, chemical and clinical pregnancy and luteal phase duration were compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202078948N1
Registration date:2012-08-17, 1391/05/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-08-17, 1391/05/27
Registrant information
Name
Sakineh Ebrahimipour
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2250
Email address
yasamin_m@yahoo.com
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2009-11-22, 1388/09/01
Expected recruitment end date
2011-06-22, 1390/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of using intravaginal progesterone in pregnancy rate in Intrauterine Insemination
Public title
The effect of progesterone in Intrauterine insemination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infertile Couples; Infertility with male factor; Cervical factor; Other unexplained cases
Exclusion criteria: Women over 40 years old; Patients with more than two times Intrauterine insemination failure; Woman with baseline FSH more than 12 IU/Lit
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
196
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
Kerman University of Medical Sciences
Street address
Afzalipour campus, Imam Highway, Kerman
City
Kerman
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
k/88/108
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
Z35.0
ICD-10 code description
Supervision of high-risk pregnancy
Primary outcomes
1
Description
Pregnancy Rate
Timepoint
21th to 30th days after Intra Uterine Insemination
Method of measurement
sonography
2
Description
Pregnancy Rate
Timepoint
14th or 17th days after Intra Uterine Insemination
Method of measurement
Blood Beta HCG
Secondary outcomes
1
Description
luteal phase period
Timepoint
2 weeks after IUI
Method of measurement
questionerer
Intervention groups
1
Description
Case Group: Progestrone, Vaginal 400 mg daily, For 10 days starting from the day after Intrauterine insemination
Category
Treatment - Drugs
2
Description
Control Group: Drug or placebo did not use.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman IVF Center
Full name of responsible person
Dr. Sakineh Ebrahimipour
Street address
Afzalipour Hospital, Imam highway, Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Shahnaz Aali
Street address
Shafa Ave., Kerman
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Aali
Position
Obstetrician and Gynecologist
Other areas of specialty/work
Street address
Afzalipour Hospital, Imam highway, Kerman
City
Kerman
Postal code
Phone
+98 34 1322 2250
Fax
-
Email
shahnaz.aali@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Shahnaz Aali
Position
Obstetrician and Gynecologist
Other areas of specialty/work
Street address
Afzalipour Hospital, Imam Highway, Kerman
City
Kerman
Postal code
Phone
+98 34 1322 2250
Fax
-
Email
shahnaz.aali@gmail.com
Web page address
www.kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Sakine Ebrahimipour
Position
Obstetrician and Gynecologist
Other areas of specialty/work
Street address
Esteghlal Ave. Kerman
City
Kerman
Postal code
Phone
+98 34 1226 5235
Fax
-
Email
Ebrahimipour.s@gmail.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)