Contact information
Type
Scientific
Primary contact
Dr C.B. Lambalk
ORCID ID
Contact details
VU University Medical Center
Department of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 4440043
cb.lambalk@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR547; 03/203
Study information
Scientific title
Acronym
Study hypothesis
Hormonal stimulation with r-FSH during IUI treatment will result in multifollicular growth in subfertile women with elevated early follicular FSH values.
Ethics approval
Received from local medical ethics committee
Study design
Randomised open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Subfertility
Intervention
Couples will undergo a maximum of 6 IUI cycles.
Group 1: Three unstimulated IUI cycles, followed by three stimulated IUI cycles with r-FSH (follitropine). R-FSH will be given starting from day 3 of the cycle until one or more follicles reach 18 mm diameter, followed by hCG administration 10,000 IU and insemination. Dose will be increased in the next cycle until multifollicular growth occurs.
Group 2: Six stimulated IUI cycles. R-FSH will be given starting from day 3 of the cycle until one or more follicles reach 18 mm diameter, followed by hCG administration 10,000 IU and insemination. Dose will be increased in the next cycle until multifollicular growth occurs.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Multifollicular growth (on day of hCG administration, measured with ultrasound).
Secondary outcome measures
1. Pregnancy rate
2. FSH doses used
3. Cancellation rate
4. Side-effects of medication
5. Treatment load
Overall trial start date
01/04/2004
Overall trial end date
01/04/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women with elevated early follicular FSH (cycle day 2-4)
2. Women between 18 and 45 years
3. Regular menstrual cycle between 25 and 35 days
4. Indication for IUI treatment
5. Normal hysterosalpingography
6. Normal serum Ca-125
7. Semen analyses: >2 million progressive motile spermatozoa
8. Ovulatory cycle
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
80
Participant exclusion criteria
1. Untreated other endocrinal pathology
2. Abnormal vaginal blood loss of unknown origin
3. Contra-indications for use of r-FSH or human choronic gonadotropin (hCG)
4. Contra-indications for pregnancy
5. Congenital uterus anomaly
6. Endometriosis more than stage II (revised ASRM score)
Recruitment start date
01/04/2004
Recruitment end date
01/04/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
Funders
Funder type
Research organisation
Funder name
Gynaecological Research Foundation (Stichting Wetenschappelijk Onderzoek Gynaecologie [SWOG])
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