Comparison the Effect of intra Uterin and Intra Muscular HCG Injection 3 Days Before Transfer in frozen Thawed Embryo Transfer Cycls in Patients with Repeated Implantation Failure
Influence of intramuscular and intrauterine HCG 3 days before embryo transfer on pregnancy outcome of frozen thawed embryo transfer cycle(FET) in patient with recurrent implantation failure.
Design
three arm parallel 70 patients group randomized through random digits number
Settings and conduct
Endometrial preparation will be done from second day of cycle with 6mg daily estradiol in patient with recurrent implantation failure who are candidate for frozen thawed embryo transfer and serial sonography will be done from 12th day of cycle ;when thickness reaches 7mm or more and patients have including criteria they will divided into 3 groups through ;in control group we just prescribe 400mg daily progesterone for 3 days and in first case group they will receive 500 unit intramuscular HCG along with 400mg progesterone ,in second case group they will receive 500 unit intrauterine HCG along with 400mg progesterone ,72 hours later all pateints will be transferred maximum 2 cleaved embryo; serum BHCG wil be checked 2weeks later and if it is positive, vaginal sonography must be done for identification of gestational sac with fetal heart beat.
Participants/Inclusion and exclusion criteria
including criteria:20-40 years old infertile patient with recurrent implantation failure who are candidate for transfering frozen thawed embryo and have adequate endometrial thickness excluding criteria: uterus malformation or adhesion, sever andometriosis or adenomyosis
Intervention groups
20-40 years old infertile woman with recurrent implantation failure who are candidate for frozen thawed embryo transfer and have appropriate endometrium received 500 unit intramuscular and intrauterine HCG along with progesterone
Main outcome variables
chemical pregnancy; clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200305046702N1
Registration date:2020-10-27, 1399/08/06
Registration timing:registered_while_recruiting
Last update:2020-10-27, 1399/08/06
Update count:0
Registration date
2020-10-27, 1399/08/06
Registrant information
Name
Zhhreh Pezeshkpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 7085
Email address
z.pezeshkpour@stu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-20, 1399/03/31
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
Comparison the Effect of intra Uterin and Intra Muscular HCG Injection 3 Days Before Transfer in frozen Thawed Embryo Transfer Cycls in Patients with Repeated Implantation Failure
Public title
Effect of HCG Injection in Frozen Thawed Embryo Transfer Cycls in Patients with Repeated Implanttion Failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
20-40 years old infertile patient with history of two or more previous impiantation failure candidate for frozen thawed embryo transfer
Exclusion criteria:
uterous malformation-sever endometriosis and adenomyosis-uterus adhesion-
egg donation
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:
210
Randomization (investigator's opinion)
Randomized
Randomization description
simple individual randomization with computerized digit number table. Randomization will be performed with simple method and random numbers generated by computer soft ware( Stat trek soft ware) wich choose the random numbers. then, we consider the specific numbers for both groups for example: the even numbres are for intervention group and the odd numbres are for the control group.
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 Research and Clinical Center for Infertility(Yazd Reproductive Sciences Institut
Street address
Research and Clinical Center for Infertility, BouAli avenue, Safaieye
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2020-06-20, 1399/03/31
Ethics committee reference number
IR.SSU.RSI.REC.1399.007
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
implantation
Timepoint
4weaks after embryo transfer
Method of measurement
observation of gestational sacs by transvaginalultrasonography
2
Description
Chemical poregnancy
Timepoint
2weaks after embryo transfer
Method of measurement
serum BHCG
Secondary outcomes
1
Description
clinical pregnancy
Timepoint
2 weaks after positive BHCG
Method of measurement
vaginal sonography
Intervention groups
1
Description
Intervention group : Endometrial preparation will be done for 20-40 years old infertile woman with recurrent implantation failure who are candidate for frozen thawed embryo transfer from second day cycle with 6 mg daily estradiol and serial sonography will be done from 12th day of cycle ; when thickness reaches 7 mm ,they receive 500 unit intramuscular HCG along with 400 mg progesterone , 3 days before embryo transfer will be done.
Category
Treatment - Drugs
2
Description
Intervention group : Endometrial preparation will be done for 20-40 years old infertile woman with recurrent implantation failure who are candidate for frozen thawed embryo transfer from second day cycle with 6 mg daily estradiol and serial sonography will be done from 12th day of cycle ; when thickness reaches 7 mm ,they receive 500 unit intrauterine HCG along with 400 mg progesterone , 3 days before embryo transfer will be done.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical Center for Infertility(Yazd Reproductive Sciences Institute)
Full name of responsible person
Dr Raziye Firouzabadi
Street address
Yazd,Safaeiyeh,Bouali ave.
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۸۷۷۳۹۱
Phone
+98 35 3824 7085
Email
info@yazd-rsi.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Masoud Mirzaei
Street address
Safaeiye-Bouali ave-Research and Clinical Center for Infertility
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
Yazd 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
Research and Clinical Center forInfertility، Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr Raziye Firouzabadi
Position
Obstetrician and Gynecologist ،Infertility and IVF Fellowship(Professor)
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Research and Clinical Center for Infertility, BouAli aven, Safaiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Email
firouzabadi@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr Raziye Firouzabadi
Position
Obstetrician and Gynecologist ،Infertility and IVF Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Research and Clinical Center for Infertility, BouAli aven, Safaiyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
firouzabadi@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Zhoreh Pezeshkpour
Position
Felowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yazd,Safaeiye,Bouali Ave,Research and Clinical center for infertility
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
Z.pezeshkpour@stu.ssu.ac.ir
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