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ISRCTN
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ISRCTN55462029
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ClinicalTrials.gov identifier
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NCT00677573
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Public title
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Urinary follicle stimulating hormone (FSH) usage in in vitro fertilisation (IVF) cycles
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Scientific title
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Comparison of efficiency of recombinant follicle stimulating hormone (rec-FSH) and highly purified urinary follicle stimulating hormone (FSH) among women undergoing assisted reproductive treatment (ART)
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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One of the most accepted patient friendly ovulation induction method for patients undergoing IVF seems to be protocols with gonadotropin-releasing hormone (GnRH) antagonist. Conceivably benefits of luteinising hormone (LH) activity and low cost may favor urinary gonadotropins.
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Ethics approval
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Ethics approval received from the Ethics Committee of the German Hospital in Istanbul on the 2nd May 2008 (ref: 17).
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Study design
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Prospective randomised controlled trial
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Countries of recruitment
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Turkey
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Disease/condition/study domain
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Primary infertility
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Participants - inclusion criteria
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1. Women less than 42 years old
2. Healthy
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Participants - exclusion criteria
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1. Any of the ovary removed surgically
2. Surgically retrieved spermatozoa
3. FSH level over 13 mIU/ml
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Anticipated start date
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25/06/2008
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Anticipated end date
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30/11/2008
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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200
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Interventions
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Group A: starts with recombinant FSH (r-FSH)
Group B: starts with only urinary FSH (u-FSH)
In both groups GnRH antagonist will be initiated when leading follicle is 13 mm or on day 6 of stimulation.
Interventions:
Serum assays of baseline FSH, LH, oestrogen (E2), progesterone, testesterone on day 2 of cycle and serum assays of LH, E2, testosterone and progesterone on human chorionic gonadotropin (HCG) day and ovum pick-up (OPU) day.
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Primary outcome measure(s)
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Number of oocytes retrieved, 12 days following embryo transfer.
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Secondary outcome measure(s)
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1. Pregnancy rate
2. Implantation rate
3. Duration of stimulation
4. Gonadotropin consumption
All secondary outcomes measured at 12 days following embryo transfer.
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Sources of funding
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1. Bahceci Women Health Care Center (Turkey)
2. German Hospital in Istanbul (Turkey)
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Trial website
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Publications
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Contact name
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Dr
Ulun
Ulug
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Address
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Alman Hastanesi
Sýraselviler Cad No 117
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City/town
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Istanbul
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Zip/Postcode
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80200
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Country
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Turkey
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Email
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ulunulug@superonline.com
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Sponsor
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Bahceci Women Health Care Center (Turkey)
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Address
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Azer Is Merkezi 44-17
Abdi Ipekci Cad
Nisantasi
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City/town
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Isanbul
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Zip/Postcode
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80200
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Country
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Turkey
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Tel
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+90 (9)212 230 0809
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Email
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mbahceci@superonline.com
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Date applied
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22/05/2008
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Last edited
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23/06/2008
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Date ISRCTN assigned
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23/06/2008
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