The purpose of this study is to assess the effectiveness of extended treatment with CC compared to treatment with gonadotropins and/or the use of intra-uterine insemination (IUI), in patients who had six ovulatory cycles after CC, but did not…
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pregnancy leading to live birth.
Secondary outcome
clinical pregnancy
miscarriage
multipel pregnancy
occurence of ovulation
Background summary
Ovulation induction with Clomiphene citrate (CC) is the first line of treatment
in women with WHO class II anovulation. Whereas almost 80% of these patients
ovulate after CC, only 40 to 50% conceive. When unsuccessful in conception,
treatment can be proceeded with gonadotropins. CC treatment is associated with
a 8% risk of multiple gestation, whereas treatment with gonadotropins is
associated with a risk of 30-40 %. At present, it is unclear for how many
cycles ovulation induction with CC should be repeated, and when to switch to
ovulation induction with gonadotropins and/or add of intra-uterine
insemination.
Study objective
The purpose of this study is to assess the effectiveness of extended treatment
with CC compared to treatment with gonadotropins and/or the use of
intra-uterine insemination (IUI), in patients who had six ovulatory cycles
after CC, but did not conceive.
Study design
Randomized multicenter controlled trial
Intervention
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 ovulation induction with
gonadotropins with IUI for 6 months
Study burden and risks
As we compare strategies that are already applied in current practice, no
additional risks or burdens are expected from the study.
Ariensplein 1
Enschede 7511 JX
NL
Ariensplein 1
Enschede 7511 JX
NL
Listed location countries
Age
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 (<10 IU/l), E2 (> 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
• 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
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2008-006171-73-NL |
| CCMO | NL25324.044.08 |
| Other | TC = 1449 (NTR) |