Impact of letrozol on oocyte quality and IVF success
Design
Two arm parallel group randomized ,double blind clinical trial with placebo control group to assess oocyte quality and IVF outcome with letrozol prescription in antagonist protocol ovarian stimulation. The sample size is 110 patient in each intervention and control group with block randomization.
Settings and conduct
This a double blind clinical trial in IVF field in Vali- e -Asr infertility center.
Infertile women who IVF candidate simultaneous with introduce ovulatory stimulating drugs received in intervention group, letrozol and in control group placebo until trigger day.36 hours after triggering ovum pickup is performed under general anesthesia .Metaphase 2 number and quality is determined by embryologist.
participants, researcher ,embryologist and statistics are blind to study groups.
With use of placebo and packing of drugs and placebo and ascertained study groups by someone outside the study , participant and researcher became blind .Evaluating the outcome is performed by researcher and embryologist who are blind.All data is delivered to statistic by researcher who is blind to study groups
Participants/Inclusion and exclusion criteria
Inclusion criteria:Infertile women who IVF condidate which 40 years old or younger and underwent antagonist protocol for ovulation stimulation
Exclusion criteria : patient with cancer , use of other IVF protocol for ovulation stimulation except antagonist protocol
Intervention groups
In intervention group,infertile women candidate for IVF, who underwent antagonist protocol ,received letrozol 5 milligram daily from day of initiation of gonadotropine drugs until day of trigger injection.
In control group,infertile women instead of letrozle received placebo, the other process is the same between two groups.
Main outcome variables
Number of Metaphase 2 oocyte
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200328046881N1
Registration date:2020-04-05, 1399/01/17
Registration timing:registered_while_recruiting
Last update:2020-04-05, 1399/01/17
Update count:0
Registration date
2020-04-05, 1399/01/17
Registrant information
Name
Mahin Bandarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4408 9406
Email address
mahbandarianmd@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-04, 1399/01/16
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of letrozol on improvement oocyte quality and IVF outcome in infertile patients underwent controlled ovarian stimulation
Public title
Impact of letrozol on oocyte quality and IVF success
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile patient that IVF candidate with 40 years old or less
use of antagonist protocol for IVF
Exclusion criteria:
Patient with cancer
Use of IVF protocol except antagonist protocol
Age
From 17 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
220
More than 1 sample in each individual
Number of samples in each individual:
2
Serum specimen for estradiol and testostrone measurement _Folicular fluid
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization
In this study all of participation, consist of 220 individuals , dividing to 55 blocks with 4 persons . In each block, equal number of intervention and control groups exist. These 55 blocks , are in 55 different arrangements of intervention and control groups
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants after signed informed constant , randomly assigned to either study groups and received drug or placebo which is thoroughly identical and same package.
patients are blind to which groups that belong to.
Researcher is blind by preparing and packing of drugs and placebo and ascertaining control or intervention groups is done by someone outside the study.
Study outcomes partly is done by researcher who blind to study groups and other part by embryologist who is blind to study groups.
All data will deliver to statistics by researcher who blind to study groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in the research of Imam Khomeini Hospital Complex, Tehran University of Medical Sci
Street address
End of Keshavarz Blvd., Dr. Gharib St., Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2020-03-14, 1398/12/24
Ethics committee reference number
IR.TUMS.IKHC.REC.1399.004
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
2
Description of health condition studied
Infertility
ICD-10 code
N97.1
ICD-10 code description
Female infertility of tubal origin
3
Description of health condition studied
Infertility
ICD-10 code
N97.2
ICD-10 code description
Female infertility of uterine origin
4
Description of health condition studied
Infertility
ICD-10 code
N97.8
ICD-10 code description
Female infertility of other origin
5
Description of health condition studied
Infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
6
Description of health condition studied
Infertility
ICD-10 code
Z31.81
ICD-10 code description
Encounter for male factor infertility in female patient
Primary outcomes
1
Description
Number of metaphase 2 oocyte
Timepoint
After ovum pick up
Method of measurement
Number of metaphase 2 by counting metaphase 2 oocyte by embryologist
Secondary outcomes
1
Description
Oocyte quality
Timepoint
After ovum pick up
Method of measurement
Based on morphology of different parts of metaphase 2 oocyte which determined by embryologist
2
Description
Oocyte maturation rate
Timepoint
After ovum pickup
Method of measurement
Number of metaphase2 oocytes divided to number of picked up oocytes
3
Description
Fertilization rate
Timepoint
After injection of sperm to metaphase 2 oocyte
Method of measurement
Number of 2PN divided to number of metaphase 2 oocyte that injected
4
Description
Clinical pregnancy rate
Timepoint
After embryo transfer
Method of measurement
Number of pregnancy that confirmed with presence of gestational sac in ultrasonography divided to number of fresh or frozen embryo transfer cycles
Intervention groups
1
Description
Intervention group: Simultaneous with introduce stimulation ovulation drugs , tablet letrozol 2.5 milligram (Iran hormone company )two time a day until trigger day will receive.
Category
Treatment - Drugs
2
Description
Control group: This group simultaneous with introduce ovulation stimulation drugs , received two tablets of letrozol placebo (Iran hormone company ) a day until trigger day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali- e -asr hospital
Full name of responsible person
Masoumeh MasoumiI
Street address
Vali - e -asr hospital , Imam khomeini institute , Eastern bagher khan Ave , Chamran High way , Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6693 9320
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
P.O Box 1417653761 , Vice Chancellor for Research and Technology, 6th floor, Central Organization of Tehran University of Medical Sciences, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mahin Bandarian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Vali - e - Asr hospital, Eastern bagherkhan Ave , Chamran High way, Tohid Square