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Therapy for Infertile PCOS Patients Ovulating Under Clomiphene Citrate or Metformin

NCT00502229 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2013-04-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Clomiphene citrate, metformin, highly purified urinary FSH

Sponsors & Collaborators

  • University Magna Graecia

    lead OTHER

Principal Investigators

  • Stefano Palomba, MD · Department of Obstetrics & Gynecology, University "Magna Graecia" of Catanzaro

  • Francesco Orio, MD · Department of Endocrinology, University "Federico II" of Naples

  • Achille Tolino, MD · Department of Obstetrics & Gynecology, University "Federico II" of Naples

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-01-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00502229 on ClinicalTrials.gov