Ovulation induction in women with newly diagnosed polycystic ovary syndrome. A randomised double blind clinical trial comparing clomiphene citrate plus metformin with clomiphene citrate plus placebo.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24655

Enrollment

228

Registered

2005-09-15

Start date

2001-06-01

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

Multi centred, double blind, placebo controlled trial. Patients were recruted from secondary and tertiary hospitals.

Interventions

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 reas

Eligibility

Inclusion criteria

Inclusion criteria: All patients with chronic anovulation WHO type II, polycystic ovaries diagnosed by transvaginal ultrasonography and child wish.

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

Measure	Time frame
Ovulation.	—

Secondary

Measure	Time frame
1. Ongoing pregnancy; 2. Sponteneous abortion; 3. Clomiphene citrate resistance.	—

Contacts

Public ContactEtelka Moll

Academic Medical Center (AMC), Department of Obstetrics and Gynecology, P.O. Box 22660

E.Moll@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)