Urinary follicle stimulating hormone (FSH) usage in in vitro fertilisation (IVF) cycles
| ISRCTN | ISRCTN55462029 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55462029 |
| ClinicalTrials.gov (NCT) | NCT00677573 |
| Protocol serial number | N/A |
| Sponsor | Bahceci Women Health Care Center (Turkey) |
| Funders | Bahceci Women Health Care Center (Turkey), German Hospital in Istanbul (Turkey) |
- 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
Scientific
Alman Hastanesi
Sýraselviler Cad No 117
Istanbul
80200
Türkiye
| ulunulug@superonline.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Number of oocytes retrieved, 12 days following embryo transfer. |
| Key secondary outcome measure(s) |
1. Pregnancy rate |
| Completion date | 30/11/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
80200
Türkiye
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/02/2019: No publications found. Verifying results with principal investigator
