Contact information
Type
Scientific
Primary contact
Dr Ulun Ulug
ORCID ID
Contact details
Alman Hastanesi
Sýraselviler Cad No 117
Istanbul
80200
Turkey
ulunulug@superonline.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00677573
Protocol/serial number
N/A
Study information
Scientific title
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)
Acronym
Study hypothesis
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.
Ethics approval
Ethics approval received from the Ethics Committee of the German Hospital in Istanbul on the 2nd May 2008 (ref: 17).
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Primary infertility
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Number of oocytes retrieved, 12 days following embryo transfer.
Secondary outcome measures
1. Pregnancy rate
2. Implantation rate
3. Duration of stimulation
4. Gonadotropin consumption
All secondary outcomes measured at 12 days following embryo transfer.
Overall trial start date
25/06/2008
Overall trial end date
30/11/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women less than 42 years old
2. Healthy
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
200
Participant exclusion criteria
1. Any of the ovary removed surgically
2. Surgically retrieved spermatozoa
3. FSH level over 13 mIU/ml
Recruitment start date
25/06/2008
Recruitment end date
30/11/2008
Locations
Countries of recruitment
Turkey
Trial participating centre
Alman Hastanesi
Istanbul
80200
Turkey
Sponsor information
Organisation
Bahceci Women Health Care Center (Turkey)
Sponsor details
Azer Is Merkezi 44-17
Abdi Ipekci Cad
Nisantasi
Isanbul
80200
Turkey
+90 (9)212 230 0809
mbahceci@superonline.com
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Bahceci Women Health Care Center (Turkey)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
German Hospital in Istanbul (Turkey)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary