Therapy for Infertile PCOS Patients Ovulating Under Clomiphene Citrate or Metformin

NCT00502229 | Withdrawn Phase 4

• 1 other identifier: 05/2006c
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Polycystic Ovary Syndrome; Infertility

Keywords

Clomiphene citrate; Controlled overian stimulation; Infertility; Metformin; Polycystic ovary syndrome; Treatment

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

  one year

Secondary Outcomes (1)

• Ovulation rate Abortion rate Live-birth rate Adverse events

  one year

Study Arms (2)

Group A

ACTIVE COMPARATOR

Continuing treatment

Drug: Clomiphene citrate, metformin, highly purified urinary FSH

Group B

ACTIVE COMPARATOR

Gonadotrophins

Drug: Clomiphene citrate, metformin, highly purified urinary FSH

Interventions

Clomiphene citrate, metformin, highly purified urinary FSH DRUG

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Polycystic ovary syndrome (using NIH criteria)
• Anovulatory infertility (using WHO criteria)

You may not qualify if:

• Age \<18 or \>35 years
• Severe obesity (BMI \>35)
• Neoplastic, metabolic, hepatic, and cardiovascular disorders or other concurrent medical illnesses
• Hypothyroidism, hyperprolactinemia, Cushing's syndrome, and non-classical congenital adrenal hyperplasia
• Current or previous (within the last six months) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetic and anti-obesity drugs or other hormonal drugs
• Intention to start a diet or a specific program of physical activity
• Organic pelvic diseases
• Previous pelvic surgery
• Suspected peritoneal factor infertility
• Tubal or male factor infertility or sub-fertility

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

Pugliese Hospital

Catanzaro, Catanzaro, CZ, 88100, Italy

Location

Related Publications (3)

• Palomba S, Orio F Jr, Falbo A, Russo T, Tolino A, Zullo F. Clomiphene citrate versus metformin as first-line approach for the treatment of anovulation in infertile patients with polycystic ovary syndrome. J Clin Endocrinol Metab. 2007 Sep;92(9):3498-503. doi: 10.1210/jc.2007-1009. Epub 2007 Jun 26.

  PMID: 17595241 BACKGROUND

• Palomba S, Orio F Jr, Falbo A, Manguso F, Russo T, Cascella T, Tolino A, Carmina E, Colao A, Zullo F. Prospective parallel randomized, double-blind, double-dummy controlled clinical trial comparing clomiphene citrate and metformin as the first-line treatment for ovulation induction in nonobese anovulatory women with polycystic ovary syndrome. J Clin Endocrinol Metab. 2005 Jul;90(7):4068-74. doi: 10.1210/jc.2005-0110. Epub 2005 Apr 19.

  PMID: 15840746 BACKGROUND

• Palomba S, Falbo A, Orio F Jr, Manguso F, Russo T, Tolino A, Annamaria C, Dale B, Zullo F. A randomized controlled trial evaluating metformin pre-treatment and co-administration in non-obese insulin-resistant women with polycystic ovary syndrome treated with controlled ovarian stimulation plus timed intercourse or intrauterine insemination. Hum Reprod. 2005 Oct;20(10):2879-86. doi: 10.1093/humrep/dei130. Epub 2005 Jun 15.

  PMID: 15958399 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility

Interventions

Clomiphene; Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Biguanides; Guanidines; Amidines

Study Officials

• Stefano Palomba, MD

  Department of Obstetrics & Gynecology, University "Magna Graecia" of Catanzaro

  PRINCIPAL INVESTIGATOR

• Francesco Orio, MD

  Department of Endocrinology, University "Federico II" of Naples

  PRINCIPAL INVESTIGATOR

• Achille Tolino, MD

  Department of Obstetrics & Gynecology, University "Federico II" of Naples

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 12, 2007
• First Posted: July 17, 2007
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

IT (1)