pregnancy outcome of Endometrial preparation with letrozol for frozen thawed embryo transfer in woman with pco syndrom
Design
Two arm parallel 90 patient group quasi randomised as for visited day(odd or even)
Settings and conduct
Infertile PCO patients candidate for frozen thawed embryo transfer stand into two group.in control group will get 6mg estradiol from second day of cycle and serial vaginal sonography will be done from 12th day of cycle when thickness reaches 7mm or more, they receive 400 mg progesterone for 3 days and then embryo transfer will be done.Intervention group will get 5mg letrozol from day 3 to 7 of cycle and vaginal sonography will be done on day 10.If we have 14mm or more dominant follicle ,vaginal sonography will be done every other day till reaching to 17mm follicle and 7-9 mm endometrium.if we don't have dominant follicle on day 10 ,75 mg daily HMG will be add to letrozol and follow up sonography will be done till reaching to our golds.after reaching to dominant follicle 10000 unit HCG will be prescribe at 10 pm and 400 mg daily progesterone will be prescribe after 2 days and 3 days after that ,2 three-day embryo will transfer.If we don't have dominant follicle on 17th days of cycle ,cycle will be canceled.2 weeks after transfer serum BHCG will check and 4 weeks after vaginal sonography will be done for gestational sac and detecting fetal heart rate.
Participants/Inclusion and exclusion criteria
inclusion criteria :
infertile pco patient
exclusion criteria :
other cause of infertility
age <20yr and >40yr
recurrent abortion
uterus malformation
Intervention groups
infertile pco patient candidate for frozen thawed embryo transfer divide to two group ,in control group we use estradiol for endometrial preparation and in other group we use letrozol for endometrial preparation
Main outcome variables
implantation rate
chemical pregnancy rate
clinical pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151013024512N6
Registration date:2020-02-29, 1398/12/10
Registration timing:registered_while_recruiting
Last update:2020-02-29, 1398/12/10
Update count:0
Registration date
2020-02-29, 1398/12/10
Registrant information
Name
Abbas Aflatoonian
Name of organization / entity
Yazd research and clinical center for infertility
Country
Iran (Islamic Republic of)
Phone
+98 358247085
Email address
abbas-aflatoonian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Endometrial preparation with letrozol in frozen embryo transfer cycle in woman with pco syndrom
Public title
uterus preparation with letrozol for polycystic patients in frozen embryo transfer cycle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
infertile pcos patients with frozen embryos
Exclusion criteria:
other cause of infertility
age<20yr and age>40 yr
recurrent abortion
uterus malformations
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Not 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 Reproductive Sciences Institute Shahid Sadoughi University
Intervention group :Infertile 20-40 yr PCO candidate for frozen thawed embryo transfer will get 5mg letrozol from day 3 to 7 of cycle and vaginal sonography will be done on day 10.If we have 14mm or more dominant follicle ,vaginal sonography will be done every other day till reaching to 17mm follicle and 7-9 mm endometrium.if we don't have dominant follicle on day 10 ,75 mg daily HMG will be add to letrozol and follow up sonography will be done till reaching to our golds.after reaching to dominant follicle 10000 unit HCG will be prescribe at 10 pm and 400 mg daily progesterone will be prescribe after 2 days and after 5 days of injecting HCG ,embryo transferring will be done.
Category
Treatment - Drugs
2
Description
Control group: Infertile 20-40 yr PCO candidate for frozen thawed embryo transfer will get 6mg estradiol from second day of cycle and serial vaginal sonography will be done from 12th day of cycle when thickness reaches 7mm or more, they receive 400 mg progesterone for 3 days and then embryo transfer will be done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical Center for Infertility(Yazd Reproductive Science Institute) Shahid Sadoughi Un
Full name of responsible person
Dr.Abass Aflatounian
Street address
Yazd, Bouali Ave, Safayeh، Research and Clinical Center for Infertility
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
info@yazd-rsi.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Shahid Sadoughi university of medical science, Yazd ,Iran
Full name of responsible person
Dr Abbas Aflatoonian
Street address
Research and Clinical Center for Infertility,Bouali avenue,Safaiyeh,Iran
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7086
Email
info@yazd-rsi.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Shahid Sadoughi university of medical science, Yazd ,Iran
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
Yazd research and clinical center for infertility
Full name of responsible person
Abbas Aflatoonian
Position
Obstetrician and Gynecologist,Infertility and IVF Fellowship(Professor)
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali Ave,Safaiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 358247085
Fax
Email
abbas-aflatoonian@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Research and Cinical Center for Infertility,Shahid Sadoughi University of Medical Science
Full name of responsible person
Abbas Aflatoonian
Position
Obstetrician and Gynecologist ,Infertility Fellowship(Professor)
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Bouali Ave,Safaiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 358247085
Fax
Email
abbas-aflatoonian@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Yasamin Mehrolhasani
Position
Infertility Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Safaeiyeh-Bouali avenue
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
yasamin_m@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD