The online version of this article (doi:10.1186/1477-7827-10-114) contains supplementary material, which is available to authorized users.
The authors declare that they have no competing interests.
RG Study design, critical discussion. LSPE Study design, critical discussion. FR Study design, critical discussion. BC Study design, execution, critical discussion. SC Execution, critical discussion. AF Recruitment, execution. AV Recruitment , execution. MRM Recruitment, execution. CM Study design, critical discussion. PA Execution, analysis, manuscript drafting. SE Study design, analysis, manuscript drafting and critical discussion. All authors read and approved the final manuscript.
The aim of the present randomised controlled non-inferiority trial is to test whether in women with compromised ovarian reserve requiring in vitro fertilisation, a protocol of ovarian stimulation using exclusively clomiphene citrate performs similarly to a regimen with high doses of gonadotropins.
Women with day 3 serum FSH > 12 IU/ml on at least two occasions or previous poor response to hyper-stimulation were recruited at four Italian infertility units. Selected women were allocated to clomiphene citrate 150 mg/day from day 3 to day 7 of the cycle (n=145) or to a short protocol with GnRH agonist 0.1 mg and recombinant FSH 450 IU daily (n=146). They were randomised by means of a computer-generated list into two groups. The study was not blinded. The main outcome of the study was the delivery rate per started cycle.
The study was interrupted after the scheduled two years of recruitment before reaching the sample size. 148 women were allocated to clomiphene citrate and 156 to the short protocol with high doses of gonadotropins; 124 and 125 participants were analysed in the groups, respectively. Women allocated to high doses of gonadotropins retrieved more oocytes and had a higher probability to perform embryo-transfer. However, the chances of success were similar. The delivery rate per started cycle in women receiving clomiphene citrate and high-dose gonadotropins was 3% (n=5) and 5% (n=7), respectively (p=0.77). The mean estimated cost per delivery in the two groups was 81,294 and 113,107 Euros, respectively. No side-effects or adverse events were observed.
In women with compromised ovarian reserve selected for in vitro fertilisation, ovarian stimulation with clomiphene citrate or high-dose gonadotropins led to similar chances of pregnancy but the former is less expensive.
Trial registered on http://www.clinicaltrials.gov (NCT01389713)
Authors’ original file for figure 112958_2012_1040_MOESM1_ESM.pdf
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- Clomiphene citrate versus high doses of gonadotropins for in vitrofertilisation in women with compromised ovarian reserve: a randomised controlled non-inferiority trial
Paolo E Levi-Setti
- BioMed Central
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