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Ovarian stimulation with r-FSH for women with high early follicular FSH and IUI indication.


- candidate number1890
- NTR NumberNTR547
- ISRCTNISRCTN14825568
- Date ISRCTN created14-feb-2006
- date ISRCTN requested13-jan-2006
- Date Registered NTR13-dec-2005
- Secondary IDs03/203 
- Public TitleOvarian stimulation with r-FSH for women with high early follicular FSH and IUI indication.
- Scientific TitleOvarian stimulation with r-FSH for women with high early follicular FSH and IUI indication.
- ACRONYMN/A
- hypothesisHormonal stimulation with r-FSH during IUI treatment will result in multifollicular growth in subfertile women with elevated early follicular FSH values.
- Healt Condition(s) or Problem(s) studiedSubfertility
- Inclusion criteria1. 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.
- Exclusion criteria1. Untreated other endocrinal pathology; 2. Abnormal vaginal blood loss of unknown origine; 3. Contra-indications for use of r-FSH or hCG; 4. Contra-indications for pregnancy; 5. Congenital uterus anomaly; 6. Endometriosis more than stage II (revised ASRM score).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-apr-2004
- planned closingdate1-apr-2008
- Target number of participants80
- InterventionsCouples 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.
- Primary outcomeMultifollicular growth (on day of hCG administration, measured with ultrasound).
- Secondary outcome1. Pregnancy rate; 2. FSH doses used; 3. Cancellation rate; 4. Side-effects of medication; 5. Treatment load.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. C.B. Lambalk
- CONTACT for SCIENTIFIC QUERIESDr. C.B. Lambalk
- Sponsor/Initiator VU University Medical Center, Department of Obstetrics and Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek Gynaecologie (SWOG)
- PublicationsN/A
- Brief summaryProspective, randomised, open study for effectiveness of ovarian stimulation in subfertile women with elevated early follicular FSH values wishing to conceive. Women will be randomised between six stimulated IUI cycles or 3 unstimulated followed by 3 stimulated cycles.
- Main changes (audit trail)
- RECORD13-dec-2005 - 6-mrt-2006


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