Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000294853
Ethics application status
Approved
Date submitted
23/02/2012
Date registered
14/03/2012
Date last updated
14/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A trial to compare highly purified human menopausal gonadotropins (hMG) and recombinant follicular stimulating hormone (rFSH) to improve pregnancy rates in infertile women
Scientific title
A randomised open-label trial comparing highly purified human menopausal gonadotropins (hMG) and recombinant follicular stimulating hormone (rFSH) in a gonadotrophin releasing hormone (GnRH) agonist cycle for infertile women to improve pregnancy rates
Secondary ID [1] 280025 0
'Nil'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infertility 285937 0
Condition category
Condition code
Reproductive Health and Childbirth 286126 286126 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
120 infertility patients randomly divided in two groups. Highly purified human menopausal gonadotrophine(menopur) 150IU once a day was given to first group, recombinant FSH(Gonal F)150IU once a day was given to second group for IVF/ICSI cycles.These drugs were given every day subcutaneously, beginning from third day of menstrual cycle up to the day that two or more follicles greater than 17mm in diameter were seen by ultrasonography
Intervention code [1] 284345 0
Treatment: Drugs
Comparator / control treatment
rFSH treatment of 60 infertile women
Control group
Active

Outcomes
Primary outcome [1] 286602 0
clinical pregnancy rate which will be confirmed by getational sac seen by ultrasonography
Timepoint [1] 286602 0
three months
Secondary outcome [1] 296246 0
rate of hyperstimulation which will be determined by enlarged diameter of ovaries with multiple cysts(>7cm), hemoconcentration findings in blood count, hypoproteinemia and free fluid collection in pouch of Douglas.
Timepoint [1] 296246 0
three months

Eligibility
Key inclusion criteria
normal uterine anatomy having tubal factor and/or male factor or unexplained infertility Inclusion criterias, infertility duration were more than two years, whose basal FSH were between 2-12 IU/L and whose body mass indexes less than 35kg/m2 were included
Minimum age
23 Years
Maximum age
36 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women with previous faiure of IVF cycles, women with systemic and/or endocrine diseases, women with recurrent early pregnancy losses were excluded.

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
Completed
Date of first participant enrolment
Anticipated
23/05/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 4171 0
Turkey
State/province [1] 4171 0

Funding & Sponsors
Funding source category [1] 284781 0
University
Name [1] 284781 0
ISTANBUL UNIVERSITY
Country [1] 284781 0
Turkey
Primary sponsor type
University
Name
ISTANBUL UNIVERSITY
Address
Istanbul Universitesi Arastirma Fonu, Beyazit/Fatih 34760 Istanbul
Country
Turkey
Secondary sponsor category [1] 283668 0
None
Name [1] 283668 0
none
Address [1] 283668 0
none
Country [1] 283668 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Objective: Our aims were to compare hpHMG and rFSH for the duration of treatment, doses of the drugs used , the number of oocytes retrieved, the number of embryos obtained and hormonal status of the patients during ovarian stimulation.
Material & methods: 120 infertility patients were recruited and randomly divided into two groups.First group used hpHMG , other group used rFSH for ovulation induction before IVF. Long protocol GnRH agonist was started at 21st day of stimulation.Transvaginal ultrasonography was performed at third and eighth day of the cycle, if ovarian cyst > 20 mm was not exist, stimulation was started. Blood samples were taken at third and eighth day of the cycle , for serum levels of estradiol (E2), progesterone (P), androstenedione (A), free testosterone (fT) and dehydroepiandrosterone sulfate (DHEA-S).When two or more follicles greater than 17 mm were observed, 10.000 IU HCG was applied inramuscularly. Follicles were collected after 36 hours from the HCG injection by transvaginal USG, using 17 gauge needles.Endometrial thickness was recorded. Aspiration of each follicle 10 millimeters and above was made. Blood samples were taken again at the day of follicle aspiration day for hormonal evaluation. All blood samples were sentrifuged and plasma was extracted immediately, and stored at '-20C'.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33832 0
Address 33832 0
Country 33832 0
Phone 33832 0
Fax 33832 0
Email 33832 0
Contact person for public queries
Name 17079 0
YAVUZ AYDIN
Address 17079 0
atakent mah.soyakolimpiakent sitesi.D blok No:53 Halkali/Kucukcekmece 34303 Istanbul
Country 17079 0
Turkey
Phone 17079 0
+902126954830
Fax 17079 0
Email 17079 0
[email protected]
Contact person for scientific queries
Name 8007 0
Yavuz Aydin
Address 8007 0
atakent mah.soyakolimpiakent sitesi.D blok No:53 Halkali/Kucukcekmece 34303 Istanbul
Country 8007 0
Turkey
Phone 8007 0
+902126954830
Fax 8007 0
Email 8007 0
[email protected]

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.