No registrations found.
ID
Source
Brief title
Health condition
Subfertile women with WHO class II anovulation who are ovulatory on CC, but have not conceived in 6 ovulatory cycles.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be pregnancies leading to live birth.
Secondary outcome
Secondary outcomes will be:
- clinical pregnancy
- miscarriage
- multiple pregnancy
- occurrence of ovulation
- ongoing pregnancy
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
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.
Study design
Preganacy or end of the study after 6 months.
Intervention
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
3. Gonadotropins
4. Gonadotropins combined with IUI.
Locatie Enschede Ariënsplein
Marleen J Nahuis
Ariensplein 1
Enschede 7511 JX
The Netherlands
+31 (0)53 4872330
marleennahuis@hotmail.com
Locatie Enschede Ariënsplein
Marleen J Nahuis
Ariensplein 1
Enschede 7511 JX
The Netherlands
+31 (0)53 4872330
marleennahuis@hotmail.com
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.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL1389 |
| NTR-old | NTR1449 |
| Other | METC : P08-037 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |