All patients who meet the inclusion criteria are included after being informed of conditions of study and fill in the inform consent form and divided between two groups randomly:first group Natural cycle and second group Artificial cycle.
All patients underwent transvaginal sonography in the 1-3 days of the cycle for initial assessment of endometral thickness and rule out of ovarian cysts .
The first group on 12th cycle day undergo TVS for evaluation of follicular size and if atleast one dominant follicle >=18 mm and endometrial thickness 8 mm observed one single dose HCG 10000 IU will be administrated and embryos 4 days later will be transfered.The same day SUPP progestrone 400 mg (cyclogest) BD will be started.
On the second group n the months before starting the transfer cycle from 21 days of luteal phase GnRh agonist (busereline Merck) at a dose of 0.5mg (500mgr) daily will be started.Then on the 2th day of the next cycle estradiol valerate 2mg daily will be started and to 8mg will be adjusted based on the endometrial thickening.on the 10-12th cycle day TVS for evaluation endometr will be done and if ET>9 mm was observed SUPP progestrone (cyclogest 400mg/BD) will be added for 3 days at the same time .The embryo transfer will be scheduled at 72 hours after starting progestrone .14-16 days after embryo transfer BHCG will be done for all patients and for positive cases 6 weeks after transfer vaginal sonography will be done to see fetal heart .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031022795N3
Registration date:2016-04-03, 1395/01/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-03, 1395/01/15
Registrant information
Name
Marzieh Ghasemi
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5581
Email address
drghasemi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of fertility outcome obtained from freeze embryo transfer in natural cycle and estrogen progestrone cycle for endometrial preparation
Public title
Comparison of fertility outcome in freeze embryo transfer cycles with endometrial preparation by natural cycle or artificial cycle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: regular menses; age between 18-40 years old; an ivf cycle less than two years ago; having atleast 2 freeze embryos.
Exclusion criteria: abnormal uterine bleeding; any endometrial pathology; history of 3 previous IVF failure; any underlying disease; endometriosis; sever male factor infertility need to TESE and PESA.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Central building of Tehran University of Medical Sciences, Keshavarz Blvd., Tehran,Iran
City
Tehran
Postal code
1417614411
Approval date
2015-03-21, 1394/01/01
Ethics committee reference number
IR.TUMS.REC.1394.2051
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
4 weeks after embryo transfer
Method of measurement
Find gestational sac on transvaginal sonography
Secondary outcomes
1
Description
chemical pregnancy rate in two group
Timepoint
two weeks after transfer for biochemical pregnancy
Method of measurement
BHCG for biochemical
2
Description
rate of abortion
Timepoint
12 weeks after transfer for abortion
Method of measurement
physical examination and trans vaginal sonography for abortion
3
Description
Clinical pregnancy rate
Timepoint
4weeks for clinical pregnancy
Method of measurement
trans vaginal sonography for clinical
4
Description
Live Birth Rate
Timepoint
24 weeks after transfer for live birth rate
Method of measurement
following of patients until 26 weeks in pregnancy for live birth rate
Intervention groups
1
Description
In the natural cycle group patients will be followed with several sonography for seeing dominant follicle more than 18 mm and then 10000 IU HCG will be administrated and 4 days later the embryos will be transferred
Category
Treatment - Drugs
2
Description
On the artificial group in the months before starting the transfer cycle from 21 days of luteal phase GnRh agonist (busereline Merck) at a dose of 0.5mg (500mgr) daily will be started.Then on the 2th day of the next cycle estradiol valerate 2mg daily will be started and to 8mg will be adjusted based on the endometrial thickening.on the 10-12th cycle day TVS for evaluation endometr will be done and if ET>9 mm was observed SUPP progestrone (cyclogest 400mg/BD) will be added for 3 days at the same time .The embryo transfer will be scheduled at 72 hours after starting progestrone
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility ward, Shriati hospital
Full name of responsible person
Dr Marzieh Aghahosseini, Infertility fellowship, Professor of obestetrics and gynecology