To compare the effectiveness of clomiphene citrate with metformin versus clomiphene citrate only in women with newly diagnosed polycystic ovary syndrome with respect to ovulation, pregnancy and sponteneous abortions.
ID
Bron
Verkorte titel
Aandoening
Multi centred, double blind, placebo controlled trial. Patients were recruted from secondary and tertiary hospitals.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Ovulation.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
To compare the effectiveness of clomiphene citrate with metformin versus clomiphene citrate only in women with newly diagnosed polycystic ovary syndrome with respect to ovulation, pregnancy and sponteneous abortions.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Metformin 4dd 500mg plus clomiphene citrate 50-150mg;
Controls: Placebo 4dd plus clomiphene citrate 50-150mg;
Patients used the medication as long as they were participating in the
study. They stopped taking medication when they were clomiphene
citrate resistant, pregnant or dropped out for a different reason.
Publiek
Department of Obstetrics and Gynecology,
P.O. Box 22660
Etelka Moll
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
E.Moll@amc.uva.nl
Wetenschappelijk
Department of Obstetrics and Gynecology,
P.O. Box 22660
Etelka Moll
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
E.Moll@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All patients with chronic anovulation WHO type II, polycystic ovaries diagnosed by transvaginal ultrasonography and child wish.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Primary exclusion criteria:
1. other causes of anovulation;
2. age over 40 years;
3. liver-, kidney or heart disease/failure (i.e. abnormal results on liver function tests, serum creatinine concentration > 95 umol/l or a history of heart disease/failure) and sperm quality indicating male factor subfertility (Total Motile Count < 10 x 106).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL445 |
| NTR-old | NTR485 |
| Ander register | : N/A |
| ISRCTN | ISRCTN55906981 |