Poor ovarian response to controlled ovarian stimulation (COS) is still an important interest in assisted reproduction. To compare the effect of two protocols for mild ovarian stimulation on assisted reproductive technology (ART) outcomes in poor responders, in a randomized control study, 184 poor responder women who candidate for ART will randomly assign to two groups. In group I, women receive clomiphen/gonadotropin/antagonist protocol, and implantation; chemical and clinical pregnancy rate will compare with those of women in group II who give letrozole / gonadotropin / antagonist protocol.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107146420N3
Registration date:2011-08-10, 1390/05/19
Registration timing:registered_while_recruiting
Last update:
Update count:3
Registration date
2011-08-10, 1390/05/19
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@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
2011-08-01, 1390/05/10
Expected recruitment end date
2012-08-01, 1391/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of letrozole and clomiphen in mild protocol among infertile poor responders
Public title
Comparison of letrozole and clomiphen in mild protocol among infertile poor responders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : three or fewer oocytes were been retrieved in previous failed ART cycle; serum E2 levels ≤ 500 pg/ml on the day of hCG administration.
Exclusion criteria : BMI >30 mg/m2; endocrine or metabolic disorders; history of ovarian surgery; severe endometriosis; azoospermia in male partner.
Age
From 20 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
184
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
Ethics committee of Yazd Research and Clinical Center for infertility, Shahid Sadoughi University of
Street address
Bouali Ave, Safaeiyeh
City
Yazd
Postal code
8916877391
Approval date
1990-12-01, 1369/09/10
Ethics committee reference number
13/1389
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N70-N77
ICD-10 code description
Inflammatory diseases of female pelvic organs
Primary outcomes
1
Description
chemical pregnancy
Timepoint
12 day after embryo transfer
Method of measurement
beta hCG blood test
2
Description
clinical pregnancy
Timepoint
3 weeks after chemical pregnancy
Method of measurement
observation of fetal heart activity by transvaginal ultrasonography
3
Description
implantation rate
Timepoint
3 weeks after chemical pregnancy
Method of measurement
the ratio of the number of embryonic sacs diagnosed by sonography to the total number of the embryos transferred
Secondary outcomes
1
Description
Endometrial thickness
Timepoint
on the day of the hCG administration
Method of measurement
ultrasonography
Intervention groups
1
Description
group I: clomiphen citrate 50 mg twice a day from 3th day of menstruation cycle until 7th day of the cycle.
Category
Treatment - Drugs
2
Description
group II: letrozole 2.5 mg twice a day from 3th of the cycle until 8th day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical Center for Infertility
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Clinical Center for Infertility
Full name of responsible person
Robab Davar
Street address
Safaeiyeh, Bouali Ave
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Clinical Center for Infertility
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
Full name of responsible person
Maryam Eftekhar
Position
Reserch faculty member
Other areas of specialty/work
Street address
Safaeiyeh, Bouali Ave
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research and Clinical Center for Infertility
Full name of responsible person
Maryam Eftekhar
Position
Gynecologist/MD
Other areas of specialty/work
Street address
Safaeiyeh, Bouali Ave
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)