Condition category
Urological and Genital Diseases
Date applied
19/09/2008
Date assigned
20/11/2008
Last edited
05/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Nick Raine-Fenning

ORCID ID

Contact details

Senior Lecturer
Consultant Obstetrician
NURTURE
B-Floor
East Block
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 823 0700
nick.fenning@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IVFAFC1

Study information

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

Acronym

Study hypothesis

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

Obtained from National Health Service (NHS) research ethics committee on the 14th September 2008 (ref: 06/MRE04/33).

Study design

A prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Follicle stimulating hormone (FSH)

Primary outcome measures

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 trial start date

01/10/2006

Overall trial end date

01/04/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

128

Participant 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

Recruitment start date

01/10/2006

Recruitment end date

01/04/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Senior Lecturer, Consultant Obstetrician
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

c/o Paul Cartledge
Research Support and Commercialisation Office
University of Nottingham
University Park
Queens Medical Centre
Nottingham
NG7 2RD
United Kingdom

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

University/education

Funder name

University of Nottingham (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20353458

Publication citations

  1. Results

    Jayaprakasan K, Hopkisson J, Campbell B, Johnson I, Thornton J, Raine-Fenning N, A randomised controlled trial of 300 versus 225 IU recombinant FSH for ovarian stimulation in predicted normal responders by antral follicle count., BJOG, 2010, 117, 7, 853-862, doi: 10.1111/j.1471-0528.2010.02545.x.

Additional files

Editorial Notes