A trial comparing two commonly used doses of fertility drugs (gonadotrophins) in women likely to have normal response during in vitro fertilisation (IVF)
| ISRCTN | ISRCTN82461750 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82461750 |
| Secondary identifying numbers | IVFAFC1 |
- Submission date
- 19/09/2008
- Registration date
- 20/11/2008
- Last edited
- 05/04/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Nick Raine-Fenning
Scientific
Scientific
Senior Lecturer, Consultant Obstetrician
NURTURE
B-Floor, East Block
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 823 0700 |
|---|---|
| nick.fenning@nottingham.ac.uk |
Study information
| Study design | A prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| 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 | A randomised controlled trial of 225 versus 300 IU recombinant follicle stimulating hormone (FSH) for ovarian stimulation in predicted normal responders by antral follicle count |
| Study objectives | To test the hypothesis that, among women predicted to have a normal ovarian response, ovarian stimulation using 300 IU follicle stimulating hormone (FSH) results in retrieval of more mature oocytes than 225 IU. As of 05/04/2012, the anticipated end date of trial has been updated from 01/10/2008 to 01/04/2008. |
| Ethics approval(s) | Obtained from National Health Service (NHS) research ethics committee on the 14th September 2008 (ref: 06/MRE04/33). |
| Health condition(s) or problem(s) studied | Infertility |
| Intervention | Conventional controlled ovarian stimulation using a fixed daily doses of 225 IU or 300 IU of recombinant FSH. The total duration of treatment is 6 weeks with 2 weeks of the research medication and up to 8 weeks of follow up. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Follicle stimulating hormone (FSH) |
| Primary outcome measure | Number of mature oocytes retrieved, measured at about 2 - 3 weeks of starting the research medication. |
| Secondary outcome measures | 1. Number of follicles measuring more than 10 mm and more than 14 mm in diameter on the day of human chorionic gonadotropin (hCG) administration 2. Cycle cancellation due to poor ovarian response 3. The number of frozen embryos 4. The prevalence of moderate or severe ovarian hyperstimulation syndrome (OHSS) 5. The clinical and on-going pregnancy rates Measured at 10 weeks at the latest. |
| Overall study start date | 01/10/2006 |
| Completion date | 01/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 128 |
| Key inclusion criteria | 1. Female subjects aged between 20 and 38 years, undergoing first, second or third cycle of in vitro fertilisation (IVF)/intra-cytoplasmic sperm injection (ICSI) treatment 2. Subjects must have a regular spontaneous menstrual cycle of 21 to 35 days 3. A basal FSH level of less than or equal to 12 IU 4. Presence of both ovaries 5. Total antral follicle count of between 7 and 22. Subjects who have not had any ovarian surgery in the past. 6. Subjects, who have a body mass index (BMI) of 20 to 35 kg/m^2 7. Subjects must have signed and dated the informed consent document indicating that the subject has been informed all the pertinent aspect of the trial 8. Subjects must be willing and comply with scheduled visits, treatment plan and laboratory tests |
| Key exclusion criteria | 1. Subjects who have an ovarian cyst (greater than 20 mm) or other significant pelvic pathology (uterine anomalies, uterine fibroids, endometrioma) at screening 2. Subjects who have an antral follicle count greater than or equal to 12 with in an ovary and/or an ovary volume of greater than 10 cm^3 on 3D ultrasound 3. Subjects whose infertility is caused by recognised endocrine abnormalities such as polycystic ovarian syndrome, hyperprolactinaemia and abnormal thyroid function 4. Subjects with any contraindications to IVF/ICSI treatment 5. Subjects who are taking concurrent corticosteroids or metformin |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 01/04/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Senior Lecturer, Consultant Obstetrician
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
c/o Paul Cartledge
Research Support and Commercialisation Office
University of Nottingham, University Park
Queens Medical Centre
Nottingham
NG7 2RD
England
United Kingdom
| Website | http://www.nottingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
University/education
University of Nottingham (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Location
- United Kingdom
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2010 | Yes | No |
