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.
ID
Bron
Verkorte titel
Aandoening
Subfertile women with WHO class II anovulation who are ovulatory on CC, but have not conceived in 6 ovulatory cycles.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome will be pregnancies leading to live birth.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
Preganacy or end of the study after 6 months.
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Locatie Enschede Ariënsplein
Marleen J Nahuis
Ariensplein 1
Enschede 7511 JX
The Netherlands
+31 (0)53 4872330
marleennahuis@hotmail.com
Wetenschappers
Locatie Enschede Ariënsplein
Marleen J Nahuis
Ariensplein 1
Enschede 7511 JX
The Netherlands
+31 (0)53 4872330
marleennahuis@hotmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1389 |
| NTR-old | NTR1449 |
| Ander register | METC : P08-037 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |