The purpose of this study was to compare intramuscular injections of progesterone with oral Dydrojestrone in transfer of frozen embryos . In this Study , We perform a randomized clinical trial on 60 patients that are candidates for frozen embryo transfer for their IVF cycles.Patients entering this study are PCOS patients excluded from previous cycles because of OHSS; Patients with thin endometer in previous fresh cycles; patient with unsuccessful previous fresh cycles; patients with ready frozen embryos. We will exclude patients if they do not develop the necessary endometrial thickness, randomly divided into three groups of 20 patients.
. After preparing the endometer with estrogen, on the day that the endometrial thickness reaches 8 mm , patients will be divided randomly into three groups. (groups 1,2,3) Group one will have luteal phase support in the form of intramuscular progesterone 50 mg daily, group two will get the support by oral dydrogestrone 40 mg daily and group three will get the support with suppository vaginal progesterone 400 mg twice daily. Embryo transfer will be performed the day after starting the Progesterone. After 8 weeks, these three groups will be compared according to clinical and chemical pregnancy outcomesand abortion rates.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201406255181N15
Registration date:2014-08-04, 1393/05/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-08-04, 1393/05/13
Registrant information
Name
Batool Rashidi
Name of organization / entity
Vali E Asr Reproductive Health Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9320
Email address
bhrashidi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of Tehran University of Medical Sciences
Expected recruitment start date
2014-12-30, 1393/10/09
Expected recruitment end date
2015-12-23, 1394/10/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between oral Dydrogestrone with intramuscular and vaginal Progesterone for luteal phase support in IVF , frozen embryo transfer cycles.
Public title
A comparison between oral Dydrogestrone with intramuscular and vaginal Progesterone in frozen embryo transfer in IVF cycles.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: all patients who are candidate for freeze embryo transfer
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
School of medicine, Tehran University of medical sciences
Street address
Tehran University Building,Ghods Street,Keshavarz Blvd
City
Tehran
Postal code
Approval date
2014-07-23, 1393/05/01
Ethics committee reference number
Student thesis
Health conditions studied
1
Description of health condition studied
In vitro fertilization
ICD-10 code
Z31.2
ICD-10 code description
In vitro fertilization
Primary outcomes
1
Description
Chemical pregnancy
Timepoint
two weeks after embryo teransfer
Method of measurement
BHCG blood test
2
Description
clinical pregnancy
Timepoint
Eight weeks after embryo transfer
Method of measurement
Sonography, seeing gestational sac
Secondary outcomes
1
Description
abortion
Timepoint
2- 12 weeks after starting treatment
Method of measurement
transvaginal sonography and blood test
Intervention groups
1
Description
Intervention group one: Luteal phase support with intramuscular Progestrone 50 mg from the day of 8mm endometrial thickness.
Category
Treatment - Drugs
2
Description
Intervention group two: Luteal phase support with oral Dydrogestrone daily 40 mg from the day of 8mm endometrial thickness.
Category
Treatment - Drugs
3
Description
Intervention group three: Luteal phase support with vaginal progesterone twice daily 400 mg from the day of 8mm endometrial thickness.