The objective of this study is to determine the effect of table letrozol on improves in vitro fertilization outcome in low responder patients.This study, clinical trials, single-blind, single center are conducted in Arash women's hospital. Among women scheduled for IVF , 160 women will participated in this study(based on inclusion criteria) .Inclusion criteria :infertile women with less than 3 oocyte; AMH <1, AFC<5 oocyte in each ovarian Exclusion criteria include women with other causes of infertility. Participants will allocated in two equal groups. In intervention group, gonadotropins (150 units FSH and hmg) and 5 mg letrozole will used for ovarion stimulation. In control group, ovarian stimulation gonadotropins (150 units FSH and hmg) without letrozole will used for ovarion stimulation . Implantation and pregnancy rate, number of ovums and thickness of endometrium in both groups will compared with each other.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701291952N8
Registration date:2017-09-19, 1396/06/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-19, 1396/06/28
Registrant information
Name
Ashraf Moini
Name of organization / entity
Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
hosp_arash@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of Medical Science
Expected recruitment start date
2017-02-03, 1395/11/15
Expected recruitment end date
2017-09-07, 1396/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of ovarian stimulation with and without letrozole in improves in vitro fertilization outcome in low responder patients
Public title
Assessment the effect of ovarian stimulation with and without letrozole in IVF/ICSI outcomes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :infertile women with less than 3 oocyte; AMH <1, AFC<5 oocyte in each ovarian
Exclusion criteria:Other causes of infertility
Age
From 15 years old to 50 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
160
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 Tehran University of Medical Science
Street address
Tehran University of Medical Science, Qods Street, Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2016-12-17, 1395/09/27
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1395.1245
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
3 weeks after emberyo transfer
Method of measurement
Ultrasonography
Secondary outcomes
1
Description
Implantation
Timepoint
14 days after embryo transfer
Method of measurement
serum level of BHCG
Intervention groups
1
Description
In intervention group,gonadotropins (150 units FSH and hmg) and 5 mg letrozole will prescribed in the first 5 days of ovarian stimulation cycle.
Category
Treatment - Drugs
2
Description
In control group,p,gonadotropins (150 units FSH and hmg) will prescribed in the first 5 days of ovarian stimulation cycle.