Condition category
Urological and Genital Diseases
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
26/08/2009
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

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

Sponsor information

Organisation

VU University Medical Centre (VUMC) (Netherlands)

Sponsor details

Department of Obstetrics and Gynaecology
Division of Reproductive Medicine
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes