Objective: The Present study is designed to compare Metformin–letrozole with Metformin – Clomiphene citrate in clomiphene resistance PCO patients undergoing IUI. Materials and Methods: In this single blind randomized trial, ovarian cycles were studied in 100 clomiphene-resistant PCOS patients with normal liver, kidney and thyroid function. They were randomly allocated to Metformin–Letrozole group (n = 50) and Metformin-Clomiphene citrate group (n = 50). Chemical and clinical pregnancies were assessed after IUI. Abortion rates were determined in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138807262604N1
Registration date:2011-01-16, 1389/10/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-16, 1389/10/26
Registrant information
Name
Robab Davar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 7085
Email address
davar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and clinical center for infertility, Shahid Sadoughi university of medical sciences
Expected recruitment start date
2007-04-01, 1386/01/12
Expected recruitment end date
2008-11-21, 1387/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Metformin-Letrozole in comparison with Metfomin-Clomiphene citrate in infertile clomiphene resistant polycystic ovary patients undergoing intrauterine insemination
Public title
Comparison of Clomiphene and Letrozole in association with Metfomin in patients with anovulation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: polycystic ovary syndrome, Clomiphene resistant, normal liver function, normal kidney function, normal thyroid function. Exclusion criteria: use of Clomiphene in previous 2 months, use of metformin in previous 2 months.
Age
From 19 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
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 research and clinical center for infertility
Street address
Research and clinical center for infertility, BouAli 2 avenue, Safaieh
City
Yazd
Postal code
8916877391
Approval date
2007-10-08, 1386/07/16
Ethics committee reference number
1581
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
endometrial thickness on day of HCG administration
Timepoint
one time in each cycle
Method of measurement
distance between two layer endometrium measured by sonography
2
Description
estrogen level on day of HCG administration
Timepoint
one time in each cycle
Method of measurement
measurement of estrogen in serum
3
Description
number of follicles>18mm
Timepoint
every other day from cycle day 12
Method of measurement
by counting of follicles more than18 millimeter in sonography
4
Description
chemical pregnancy
Timepoint
2 weeks after IUI
Method of measurement
by measurement of HCG level in serum
5
Description
clinical prgnancy
Timepoint
one time in each cycle
Method of measurement
observation of gestational sac in sonography
Secondary outcomes
1
Description
abortion rate
Timepoint
one time in each treatment cycle
Method of measurement
observation of expulsion of product of conception from uterous, disappearance of gestational sac in sonography, HCG level in serum dropped or become negative
Intervention groups
1
Description
Metformin 1500mg/day for 6-8 weeks then Metformin + Clomiphene 100mg for 5 days from third day of cycle
Category
Treatment - Drugs
2
Description
Metformin 1500 mg/day for 6-8 weeks then Metformin + Letrozole 5 mg/day for 5 days from third day of cycle
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and clinical center for infertility, Shahid Sadoughi university of medical sciences
Full name of responsible person
Robab Davar M.D, obstetrician and gynecologist (assistant professor)
Street address
Research and clinical center for infertility, Bou-Ali 2, Safaieh
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and clinical center for infertility, Shahid Sadoughi university of medical sciences
Full name of responsible person
Abbas Aflatounian M.D, obstetrician and gynecologist, fellowship of infertility (professor)
Street address
Research and clinical center for infertility, Bou-Ali 2, Safaieh
City
Yazd
Grant name
1290007
Grant code / Reference number
10533
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and clinical center for infertility, Shahid Sadoughi 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
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Robab Davar M.D.
Position
obstetrician and gynecologist (assistant professor)
Other areas of specialty/work
Street address
Research and ClinicalCcenter for Infertility, Bou Ali 2, Safaieh
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
davar@ssu.ac.ir , r_davar@yahoo.com
Web page address
www.yazdivf.org , info@yazdivf.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Robab Davar M.D.
Position
obstetrician and gynecologist (assistant professor)
Other areas of specialty/work
Street address
Research and Clinical Center for Infertility, Bou Ali 2, Safaieh
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
davar@ssu.ac.ir , r_davar@yahoo.com
Web page address
www.yazdivf.org , info@yazdivf.org
Person responsible for updating data
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Robab Davar
Position
obstetrician and gynecologist (assistant professor)
Other areas of specialty/work
Street address
Research and Clinical Center for Infertility, Bou Ali 2, Safaieh
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
davar@ssu.ac.ir , r_davar@yahoo.com
Web page address
www.yazdivf.org
Sharing plan
Deidentified Individual Participant Data Set (IPD)