One of the major issues in frozen embryo transfer is coordination between endometrial growth and development of the fetus. The aim of this study is evaluation of Oestrogel effect on endometrial preparation for IVF. This is a randomized , single blind in ,3th of stage in trial and uni center study.
One hundred patient that candidate for freeze embryo transfer were enrolled in this prospective, randomized, single blind, clinical trial. Patients who candidate for fresh cycles were excluded.
Physician was not aware patient allocation.
All Patients received GNRH agonist (triptoreline 0.1mg, SC ) at 21th day of cycle and continued at least 14day , Then patients were divided in to two groups by a clinic nurse by the simple randomization , that group 1 (n=50) use of estradiol valerat tablet 8 mg per day from 1th day of menstrual until endometrial length greater than 8mm . In group 2 (n=50 ) , patients received transdermal oestrogel 8mg in the first day of menstrual cycle until endometrial length greater than 8 mm, Then embryo transfer were performed. Progesterone was given to all patients. Primary outcome is clinical pregnancy rate and secondary outcome was endometrial thickness.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016092429951N1
Registration date:2017-01-02, 1395/10/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-02, 1395/10/13
Registrant information
Name
Roya Kabodmehri
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2049
Email address
rkabodmehri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and technology centerTehran University of medical siences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Oestragel and Estradiol valerate on clinical pregnancy rate on patient that candidate for freeze embryo transfer cycle.
Public title
Effect of transdermal Estradiol gel compare Estradiol valerat on endometrial preparation in freeze embryo transfer cycle cycle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: hyperstimulation in previous cycle and non- transfer in fresh cycle; premature menu pose; menu pose; patients who candidate for embryo and egg donation
Exclusion criteria: hyper sensitivity to gonadotropin releasing hormone agonist; fresh cycle .
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
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 MedicaLSciences.
Street address
Central Building , Ghods Street.
City
Tehran
Postal code
Approval date
2015-11-10, 1394/08/19
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1312
Health conditions studied
1
Description of health condition studied
freeze transfer embryo
ICD-10 code
XIV
ICD-10 code description
Disease of the genitourinary system
2
Description of health condition studied
preparation of Endometrium for freeze embryo transfer
ICD-10 code
XIV
ICD-10 code description
Disease of the genitourinary system
Primary outcomes
1
Description
Clinical Pregnancy
Timepoint
two week after embryo transfer
Method of measurement
Blood test for confirm of pregnancy with ELISA
Secondary outcomes
1
Description
Endometrial thickness
Timepoint
13 th day of menstrual cycle
Method of measurement
Transvaginal sonography
Intervention groups
1
Description
Intervention group:In group 2 (n=50 ) , patients received transdermal oestrogel 8mg in the first day of menstrual cycle until endometrial length greater than 8 mm, Then embryo transfer were performed. Progesterone was given to all patients.
Category
Treatment - Drugs
2
Description
Control group : group 1 (n=50) received of estradiol valerat tablet 8 mg per day from 1th day of menstrual until endometrial length greater than 8mm, Then embryo transfer were performed. Progesterone was given to all patients