Urinary follicle stimulating hormone (FSH) usage in in vitro fertilisation (IVF) cycles

ISRCTN	ISRCTN55462029
DOI	https://doi.org/10.1186/ISRCTN55462029
ClinicalTrials.gov number	NCT00677573
Secondary identifying numbers	N/A

Submission date: 22/05/2008
Registration date: 23/06/2008
Last edited: 14/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ulun Ulug
Scientific

Alman Hastanesi
Sýraselviler Cad No 117
Istanbul
80200
Türkiye

Email	ulunulug@superonline.com

Study information

Study design	Prospective randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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)
Study objectives	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(s)	Ethics approval received from the Ethics Committee of the German Hospital in Istanbul on the 2nd May 2008 (ref: 17).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	25/06/2008
Completion date	30/11/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	200
Key inclusion criteria	1. Women less than 42 years old 2. Healthy
Key exclusion criteria	1. Any of the ovary removed surgically 2. Surgically retrieved spermatozoa 3. FSH level over 13 mIU/ml
Date of first enrolment	25/06/2008
Date of final enrolment	30/11/2008

Locations

Countries of recruitment

Türkiye

Study participating centre

Alman Hastanesi

Istanbul
80200
Türkiye

Sponsor information

Bahceci Women Health Care Center (Turkey)
Hospital/treatment centre

Azer Is Merkezi 44-17
Abdi Ipekci Cad
Nisantasi
Isanbul
80200
Türkiye

Phone	+90 (9)212 230 0809
Email	mbahceci@superonline.com

Funders

Funder type

Hospital/treatment centre

Bahceci Women Health Care Center (Turkey)

No information available

German Hospital in Istanbul (Turkey)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

14/02/2019: No publications found. Verifying results with principal investigator