Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000195055
Ethics application status
Approved
Date submitted
1/03/2010
Date registered
8/03/2010
Date last updated
29/12/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect Of Micronised Progesterone On Endometrial Receptivity
Scientific title
Investigation Of Endometrial Receptivity Parameters At Mid Secretory Phase When Micronised Progesterone Added During Luteal Phase in infertile Patients with Polycistic Ovaries and Unexplained Infertility
Secondary ID [1] 1460 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infertile patients with polycystic ovaries and unexplained infertility 256898 0
Condition category
Condition code
Reproductive Health and Childbirth 257046 257046 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
patients will take oral clomiphene citrate of 2 tablets(100 mg) each day,beginning at fifth day of menstruel cycle for five days.stusy group will then take micronised progesterone , 2 capsule of 200 mg(400 mg/day)beginning just after ovulation for 14 days
Intervention code [1] 256092 0
Treatment: Drugs
Comparator / control treatment
control group will take clomiphene citrate for 5 days just like treatment group in preovulatory phase,but will not take progesterone after the ovulation
Control group
Active

Outcomes
Primary outcome [1] 257936 0
We will take endometrrial biopsies from all participants by pipelle at mid-secretory period and fixe with formaline and then embed in paraffin block.After all samples collected immunohistocchemical staining and investigation and scorring under microscopy will be performed for the following;
Estrogen receptor
Progesterone receptor
Glycodelin
Interleukine(IL) 11
Leukaemia inhibitory factor (LIF), all these will be obtained as commercial antibody kits by abcam.
Timepoint [1] 257936 0
at 2 months post-intervention
Secondary outcome [1] 263443 0
chemical pregnancy rate;will be detected by blood beta human chorionic gonadotrophin(HCG) measurement after the menstreal delay for 3 days
clinical pregnancy rate; which will be detected by transvaginal ultrasonography after the menstruel delay of 7 days.
Timepoint [1] 263443 0
at 2 months post-intervention

Eligibility
Key inclusion criteria
INFERTILE PATIENTS OF POLYCYSTIC OVARIES AND UNEXPLAINED INFERTILITY
20-39 YEARS OLD
NO SYSTEMIC DISEASES
Minimum age
20 Years
Maximum age
39 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
INFERTILITY OTHER THAN polycystic ovaries(PCO) AND UNEXPLAINED,SYSTEMIC DISEASES,DRUG USERS,OVARIAN OR ENDOMETRIAL PATHOLOGIES SUCH AS MYOMA,ENDOMETRIOSIS

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
15/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 2530 0
Turkey
State/province [1] 2530 0

Funding & Sponsors
Funding source category [1] 256583 0
University
Name [1] 256583 0
ISTANBUL UNIVERSITY RESEARCH FUND
Country [1] 256583 0
Turkey
Primary sponsor type
University
Name
ISTANBUL UNIVERSITY RESEARCH FUND
Address
Vatan caddesi,ISTANBUL UNIVERSITY RESEARCH FUND,Fatih,ISTANBUL,TURKEY
area code:34303
Country
Turkey
Secondary sponsor category [1] 255878 0
None
Name [1] 255878 0
NONE
Address [1] 255878 0
NONE
Country [1] 255878 0
Turkey

Ethics approval
Ethics application status
Approved

Summary
Brief summary
primary purpose is to investigate the effect of micronised progesterone as luteal phase support on endometrium receptivity in polycystic ovaries and unexplained infertility patients.Gylcodelin,leukemia inhibitory factor and interleukin 11 are well previously defined cytokines that related with embryo implantation especially at mid secretory phase of the cycle
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30889 0
Address 30889 0
Country 30889 0
Phone 30889 0
Fax 30889 0
Email 30889 0
Contact person for public queries
Name 14136 0
YAVUZ AYDIN
Address 14136 0
Hobyar mahallesi,OBSTETRICS AND GYNECOLOGY,CERRAHPASA MEDICAL FACULTY,Fatih,ISTANBUL TURKEY
area code:34317
Country 14136 0
Turkey
Phone 14136 0
902124143000-21442
Fax 14136 0
Email 14136 0
yavuzay@istanbul.edu.tr
Contact person for scientific queries
Name 5064 0
yavuz aydin
Address 5064 0
Hobyar mahallesi,OBSTETRICS AND GYNECOLOGY,CERRAHPASA MEDICAL FACULTY,Fatih,ISTANBUL TURKEY
area code:34317
Country 5064 0
Turkey
Phone 5064 0
+902124951616
Fax 5064 0
Email 5064 0
yavuzay@istanbul.edu.tr

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.