TREATMENT ALTERNATIVES FOR SUBFERTILE WOMEN WITH CLASS II ANOVULATION NOT CONCEIVING AFTER SIX OVULATORY CYCLES WITH CLOMIPHENE CITRATE

TREATMENT ALTERNATIVES FOR SUBFERTILE WOMEN WITH CLASS II ANOVULATION NOT CONCEIVING AFTER SIX OVULATORY CYCLES WITH CLOMIPHENE CITRATE - treatment after six ovulatory cycles with clomipheen

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41546

Enrollment

660

Registered

2008-10-10

Start date

2008-12-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

anovulation subfertility

Interventions

Patients will be randomly allocated to four treatment arms: extended CC treatment for 6 months, ovulation induction with gonadotropins for 6 months, extended CC treatment with IUI for 6 months and o

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patients with six ovulatory cycles after CC treatment and no conception. Ovulation is assessed by a midluteal progesterone (> 16 nmol/l), basal temperature curve, detection of LH surge or history, depending on the local protocol. • All patients have normal serum FSH ( 80 pmol/l), prolactin (0,05 - 0,80 IU/l) and thyroid-stimulating hormone (0,4 - 4,0 mU/l). • All women have patent Fallopian tubes, proven by hysterosalpingography (HSG), a negative Chlamydia antibody titre (CAT) or diagnostic laparoscopy combined with tubal testing (DLS and TT), depending on the local protocol. • The partners have normal semen parameters according to the modified criteria of the World Health Organization (1999). • Age between 18 and 40 years.

Exclusion criteria

Exclusion criteria: • Patients who have previously been treated with gonadotropins or IVF are excluded. • Patients are excluded if they have intolerable symptoms when treated with CC like hot flashes affecting daily function, headaches, vision changes, and depression • Patients are excluded if they remain anovulatory on CC 150 mg.

Design outcomes

Primary

Measure	Time frame
Pregnancy leading to live birth.	—

Secondary

Measure	Time frame
clinical pregnancy miscarriage multipel pregnancy occurence of ovulation	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)