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, in patients who had six ovulatory cycles after CC, but did not conceive.
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
multiple pregnancy
occurrence of ovulation.
Background summary
Ovulation induction with Clomiphene citrate (CC) is the first line treatment in
subfertile 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.
Alternatives are a switch to ovulation induction with gonadotropins and/or
addition 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, in patients who had six ovulatory cycles after CC,
but did not conceive.
Study design
Multi center randomized controlled trial.
Setting: Three fertility centers in The Netherlands.
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
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: As we compare strategies that are already
applied in current practice, no additional risks or burdens are expected from
the study.
ariensplein 1
7511 JX Enschede
NL
ariensplein 1
7511 JX Enschede
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.
• 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).
• 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 are remaining anovulatory on CC 150 mg.
Design
Recruitment
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 |
|---|---|
| CCMO | NL25099.044.08 |