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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23707

Enrollment

Registered

2005-12-13

Start date

2004-04-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subfertile women with elevated early follicular FSH values

Interventions

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 t

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Multifollicular growth (on day of hCG administration, measured with ultrasound).	—

Secondary

Measure	Time frame
1. Pregnancy rate; 2. FSH doses used; 3. Cancellation rate; 4. Side-effects of medication; 5. Treatment load.	—

Contacts

Public ContactC.B. Lambalk

VU University Medical Center, Department of Reproductive Medicine, P.O. Box 7057

cb.lambalk@vumc.nl+31 (0)20 4440043

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)