to investigate the Ovarian response to letrozole combined with gonadotropin regimen in patient with decreased ovarian reserve candidate for IVF
Design
uncontrolled clinical trial,convenience sampling, quasi-experimental design of 69patients with no blinding.
Settings and conduct
This study has investigated infertile women (age 18-42 years) visited at Infertility clinic, Mahdiyeh educational hospital, between 2017-2018 and their responses to letrozole+gonadotropin regimen is assessed .
Participants/Inclusion and exclusion criteria
Inclusion criteria: women with poor ovarian response (POR) that at least two of the following three features(Bologna criteria) must be present: ( advanced maternal age or any other risk factor for POR; a previousPOR; and an abnormal ovarian reserve test);
age 18-42 yr;
previous poor ovarian response(oocyte<3) to ovarian stimulation by gonadotropin.
exclusion criteria: metabolic disease (diabetes, chronic hypertension, etc) or any underlying disease ( kidney disease, liver disease, etc.);
presence cancer or any malignancy;
genitourinary anomalies.
Intervention groups
Patients received letrozole 7.5mg/day combined with gonadotropin(FSH) 225mg/day, at day 2-3 of menstrual cycle and continued for 5 days.
Main outcome variables
number of oocytes achieved after letrozole+gonadotropine regimen;
mean endometrial thickening after letrozole+gonadotropin regimen;
rate of pregnancy after letrozole+gonadotropin regimen.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140224016705N9
Registration date:2019-12-18, 1398/09/27
Registration timing:retrospective
Last update:2019-12-18, 1398/09/27
Update count:0
Registration date
2019-12-18, 1398/09/27
Registrant information
Name
zahra heidar
Name of organization / entity
sbmu
Country
Iran (Islamic Republic of)
Phone
+98 21 4461 2416
Email address
dr_zheidar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2018-09-23, 1397/07/01
Trial completion date
2018-12-22, 1397/10/01
Scientific title
Ovarian response to letrozole combined with gonadotropin regimen in patient with diminished ovarian reserve candidate for IVF
Public title
letrozole combined with gonadotropin in infertile patients with diminished ovarian reserve
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
women with poor ovarian response that at least two of the following three features(Bologna criteria) must be present: (i) advanced maternal age or any other risk factor for POR; (ii) a previousPOR; and (iii) an abnormal ovarian reserve test.
age 18-42 years
previous poor ovarian response(oocyte<3) to ovarian stimulation by gonadotropin.
Exclusion criteria:
metabolic disease (diabetes, chronic hypertension, etc) or any underlying disease ( kidney disease, liver disease, etc.)
presence cancer or any malignancy
genitourinary anomalies
Age
From 18 years old to 42 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
72
Actual sample size reached:
69
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti university of medical sciences, Arabi Ave, Yamen St, Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.SBMU.MSP.REC.1397.463
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
number of oocytes achieved after letrozole+gonadotropine regimen
Timepoint
after ovarian puncture.
Method of measurement
reporting by embryology laboratory.
2
Description
mean endometrial thickening after letrozole+gonadotropin regimen
Timepoint
at injection day of HCG
Method of measurement
ultrasound sonography
3
Description
rate of pregnancy after letrozole+gonadotropin regimen
Timepoint
2weeks after ovarian puncture
Method of measurement
level of beta human chorionic gonadotropin in a sample of blood
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patient were treated by letrozole at 7.5 mg/day (Saha pharmaceutical company) and Gonal-f at 225 mg/day (Merck pharmaceutical company), started on the 2nd-3rd day of menstrual period and continued for 5 days. Then, once the leading follicle had reached size of 16-18mm, Ovitrelle (injectable hCG) at 250mg (Merck pharmaceutical company) was administered for pateint. The patients were monitored by ultrasonography every 2 or 3 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdiyeh hospital
Full name of responsible person
Zahra Heidar
Street address
Shishegarkhaneh Ave, Fadaeiyan Eslam St, Shoosh Sq, Tehran
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir
Web page address
http://mmc.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Heidar
Street address
Shahid Beheshti university of medical sciences, Arabi Ave, Yamen St, Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
info@sbmu.ac.ir
Web page address
https://www.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Negar Hamzehpour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Mahdie Hospital, Shishegarkhaneh Ave, Fadaeeyan Eslam St, Shoosh Sq, Tehran