No registrations found.
ID
Source
Brief title
Health condition
Subfertile women with elevated early follicular FSH values
Sponsors and support
Intervention
Outcome measures
Primary outcome
Multifollicular growth (on day of hCG administration, measured with ultrasound).
Secondary outcome
1. Pregnancy rate;
2. FSH doses used;
3. Cancellation rate;
4. Side-effects of medication;
5. Treatment load.
Background summary
Prospective, 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.
Study objective
Hormonal stimulation with r-FSH during IUI treatment will result in multifollicular growth in subfertile women with elevated early follicular FSH values.
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.
P.O. Box 7057
C.B. Lambalk
De Boelelaan 1117
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4440043
cb.lambalk@vumc.nl
P.O. Box 7057
C.B. Lambalk
De Boelelaan 1117
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4440043
cb.lambalk@vumc.nl
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.
Exclusion criteria
1. 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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL505 |
| NTR-old | NTR547 |
| Other | : 03/203 |
| ISRCTN | ISRCTN14825568 |