|- candidate number||3994|
|- NTR Number||NTR1449|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-sep-2008|
|- Secondary IDs||P08-037 METC|
|- Public Title||Treatment after six ovulatory cycles with clomiphene |
|- Scientific Title||TREATMENT ALTERNATIVES FOR SUBFERTILE WOMEN WITH CLASS II ANOVULATION NOT CONCEIVING AFTER SIX OVULATORY CYCLES WITH CLOMIPHENE CITRATE|
|- hypothesis||Gonadotropins after 5-7 ovulatory cycles with CC will lead to more multiple gestations and higher costs compared with extended CC treatment. |
Combination of CC or gonadotropins with IUI may result in a higher pregnancy rate.
|- Healt Condition(s) or Problem(s) studied||Subfertility, Ovulation, Clomiphene |
|- Inclusion criteria||1. Patients with five to seven 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. |
2. 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).
3. 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).
4. The partners have normal semen parameters according to the modified criteria of the World Health Organization (1999).
5. Age between 18 and 40 years.
|- Exclusion criteria||1. Patients who have previously been treated with gonadotropins or IVF are excluded. |
2. Patients are excluded if they have intolerable symptoms when treated with CC like hot flashes affecting daily function, headaches, vision changes, and depression.
3. Patients are excluded if they are remaining anovulatory on CC 150 mg.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2008|
|- planned closingdate|
|- Target number of participants||660|
|- Interventions||To study the effectiveness of the following interventions in patients who have not conceived after 5 to 7 ovulatory cycles with CC treatment|
1. Extended CC treatment
2. Extended CC treatment combined with IUI
4. Gonadotropins combined with IUI.
|- Primary outcome||The primary outcome will be pregnancies leading to live birth. |
|- Secondary outcome||Secondary outcomes will be:|
- clinical pregnancy
- multiple pregnancy
- occurrence of ovulation.
|- Timepoints||Preganacy or end of the study after 6 months. |
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Marleen J Nahuis|
|- CONTACT for SCIENTIFIC QUERIES|| Marleen J Nahuis|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|Medisch Spectrum Twente, Enschede|
|- Brief 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. |
|- Main changes (audit trail)||Secondary outcome:|
- Ongoing pregnancy
|- RECORD||16-sep-2008 - 5-jul-2015|