drugset / Trial / NCT00502229

Therapy for Infertile PCOS Patients Ovulating Under Clomiphene Citrate or Metformin

NCT00502229

Phase 4 Withdrawn University Magna Graecia
RandomizedParallel-groupOpen-labelTreatment

Summary

Several data demonstrated that both clomiphene citrate (CC) and metformin are two safe and valid first-step options to induce ovulation in infertile anovulatory PCOS patients. Notwithstanding a high percentage of patients ovulate under treatment, only \~40% and 60% of subjects obtain a pregnancy after CC and metformin, respectively. For these patients, controlled ovarian stimulation (COS) followed by intrauterine insemination (IUI) could be the next therapeutic step before assisted reproductive techniques since IUI improves significantly the fertility in couples with unexplained infertility. Furthermore, to date it is not defined if COS should be obtained using the same ovulatory agent (CC or metformin) or switching the treatment to gonadotropins. In this view, the aim of the present study will be to evaluate the best management of infertile PCOS patients ovulating after CC or metformin.

Timeline

Start
2010-01
Primary completion
2011-01
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clomiphene Other / unclassified
Comparator Highly purified urinary FSH Unknown
Comparator Metformin Small molecule