This study is a prospective randomized study(Randomized numbers' table).the aim of this study is evaluation of effect of GnRH-a in endometrial preparation for frozen-thawed embryo transfer cycles in patient with repeated implantation failure.inclusion criteria:infertile womem(18-42) who are candidate for frozen-thawed embryo transfer; with at least 2 previous failed implantation.Eexclusion criteria :oocyte donation;intrauterine lesion;history of less than 2 previous failed implantation. at first patient divided in two groups: in case group patient receive 0.1 mg GnRH-a daily sc. from day 21 of previous cycle. From cycle day 2, dose of GnRH-a reduce to 0.05 mg and oral estradiol is started 6mg daily.In control group, patients receive oral estradiol 6 mg daily without GnRH_a from day 2. When endomwtrial thickness is atleast 7.5 mm ,vaginal progestrone 400 mg twice daily is started. In both group ,When endometrial thickness is at least 7.5 mm ,vaginal progestrone400 mg twice daily is started and GnRH-a is stoped in case group .Embryo transfer is done on day 4 of progestrone. Main outcomes: pregnancy test (serum BHCG) is done 14 days after ET(chemical pregnancy) . fetal heartbeat is checked 2-3 weeks after positive BHCG test(clinical pregnancy).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201708292604N3
Registration date:2017-09-18, 1396/06/27
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-09-18, 1396/06/27
Registrant information
Name
Robab Davar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 7085
Email address
davar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahid Sadoughi Universit,y of Medical Sciences, Yazd,Iran
Expected recruitment start date
2017-09-16, 1396/06/25
Expected recruitment end date
2017-12-16, 1396/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of GnRH-a in endometrial preparation for frozen-thawed embryo transfer cycles in patient with repeated implantation failure.
Public title
ٍٍEffect of GnRH-a in endometrial preparation for frozen-thawed embryo transfer cycles in patient with repeated implantation failure.
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:infertile womem(18-42) who are candidate for frozen-thawed embryo transfer; with at least 2 previous failed implantation.
exclusion criteria :oocyte donation;intrauterine lesion;history of less than 2 previous failed implantation.
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
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
Street address
yazd reproductive sciences institute
City
yazd
Postal code
8916877391
Approval date
2017-05-21, 1396/02/31
Ethics committee reference number
17/1/62415/پ
Health conditions studied
1
Description of health condition studied
repeated implantation failure
ICD-10 code
N98.9
ICD-10 code description
complication associated with artificial fertilization ,unspecified
Primary outcomes
1
Description
chemical pregnancy
Timepoint
2 weeks after emberyo transfer
Method of measurement
serum BHCG
Secondary outcomes
1
Description
clinical pregnancy
Timepoint
2-3 weeka after positive pregnancy test
Method of measurement
sonography(fetal heartbeat)
Intervention groups
1
Description
In case group , patients receive daily subcutaneous injections of 0.1 mg of GnRH-a( diphereline) starting from day 21 of previous cycles.The dose is reduce to 0.05 mg from the second day of cycle when daily oral estradiol valerate 6mg is also started.Daily vaginal progesterone 400mg twice daily is started when endometrial thickness is > 7.5 mm and GnRH_a is also stopped.
Category
Treatment - Drugs
2
Description
In control group oral estradiol 6mg daily is started from day 2 cycle without diphereline. Daily vaginal progesterone 400mg twice daily is started when endometrial thickness is > 7.5 mm
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd reproductive sciences Institute
Full name of responsible person
dr.robab davar
Street address
Yazd safaeye booali ave.
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
yazd reproductive sciences institute,shahid sadoughi university