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Treatment of Anovulatory Infertility in PCOS Patients

Primary Purpose

Infertility, Polycystic Ovary Syndrome, Anovulation

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Clomiphene citrate
Metformin
Sponsored by
University Magna Graecia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Anovulation, Clomiphene citrate, Infertility, Metformin, PCOS, Treatment

Eligibility Criteria

18 Years - 41 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Anovulatory infertility related to polycystic ovary syndrome

Exclusion Criteria:

  • 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, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs.
  • Organic pelvic diseases
  • Previous pelvic surgery
  • Suspected peritoneal factor infertility
  • Tubal or male factor infertility or sub-fertility

Sites / Locations

  • "Pugliese Hospital"

Outcomes

Primary Outcome Measures

Pregnancy rate

Secondary Outcome Measures

Ovulation rate
Abortion rate
Time to first pregnancy
Adverse events
N. pregnancies/n. ovulatory cycles

Full Information

First Posted
May 8, 2007
Last Updated
May 8, 2007
Sponsor
University Magna Graecia
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1. Study Identification

Unique Protocol Identification Number
NCT00471523
Brief Title
Treatment of Anovulatory Infertility in PCOS Patients
Official Title
Clomiphene Citrate Versus Metformin as First-Line Approach for the Treatment of Anovulation in Infertile Patients With Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Magna Graecia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Clomiphene citrate (CC) and metformin are two effective drugs used to induce ovulation in patients with polycystic ovary syndrome (PCOS), even if it is still unclear which compound between them should be initially administered. The aim of the study will be to compare in a clinical setting the efficacy of CC and metformin as first-line approaches for treating anovulation in infertile PCOS patients.
Detailed Description
Eighty infertile anovulatory patients with PCOS will be allocated in two body mass index (BMI)- and age-matched groups (experimental and control groups). Forty patients will receive the experimental treatment consisting of six months of 1700 mg/day metformin administration (experimental group), whereas other forty patients will receive CC administered using a traditional incremental-doses protocol (control group). In both groups, patients who will ovulate under treatment will continue the therapy for a total of six months. During the study, the clinical and reproductive outcomes, and the adverse experience will be evaluated in each patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Polycystic Ovary Syndrome, Anovulation
Keywords
Anovulation, Clomiphene citrate, Infertility, Metformin, PCOS, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Clomiphene citrate
Intervention Type
Drug
Intervention Name(s)
Metformin
Primary Outcome Measure Information:
Title
Pregnancy rate
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Ovulation rate
Time Frame
6 months
Title
Abortion rate
Time Frame
10 months
Title
Time to first pregnancy
Time Frame
10 months
Title
Adverse events
Time Frame
10 months
Title
N. pregnancies/n. ovulatory cycles
Time Frame
10 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Anovulatory infertility related to polycystic ovary syndrome Exclusion Criteria: 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, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs. Organic pelvic diseases Previous pelvic surgery Suspected peritoneal factor infertility Tubal or male factor infertility or sub-fertility
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefano Palomba, MD
Organizational Affiliation
Department of Obstetrics & Gynecology, University "Magna Graecia" of Catanzaro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Achille Tolino, MD
Organizational Affiliation
Department of Obstetrics & Gynecology, University "Federico II" of Naples
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francesco Orio, MD
Organizational Affiliation
Department of Endocrinology, University "Federico II" of Naples
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Pugliese Hospital"
City
Catanzaro
State/Province
CZ
ZIP/Postal Code
88100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
15840746
Citation
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.
Results Reference
background
PubMed Identifier
17074337
Citation
Palomba S, Orio F Jr, Falbo A, Russo T, Tolino A, Zullo F. Effects of metformin and clomiphene citrate on ovarian vascularity in patients with polycystic ovary syndrome. Fertil Steril. 2006 Dec;86(6):1694-701. doi: 10.1016/j.fertnstert.2006.05.035. Epub 2006 Oct 30.
Results Reference
background
PubMed Identifier
16798282
Citation
Palomba S, Orio F, Zullo F. Ovulation induction in women with polycystic ovary syndrome. Fertil Steril. 2006 Jul;86 Suppl 1:S26-7. doi: 10.1016/j.fertnstert.2006.03.018.
Results Reference
background
PubMed Identifier
16835214
Citation
Palomba S, Russo T, Orio F Jr, Falbo A, Manguso F, Sammartino A, Tolino A, Colao A, Carmina E, Zullo F. Uterine effects of clomiphene citrate in women with polycystic ovary syndrome: a prospective controlled study. Hum Reprod. 2006 Nov;21(11):2823-9. doi: 10.1093/humrep/del267. Epub 2006 Jul 10.
Results Reference
background
PubMed Identifier
18440534
Citation
Palomba S, Falbo A, Orio F Jr, Tolino A, Zullo F. Efficacy predictors for metformin and clomiphene citrate treatment in anovulatory infertile patients with polycystic ovary syndrome. Fertil Steril. 2009 Jun;91(6):2557-67. doi: 10.1016/j.fertnstert.2008.03.011. Epub 2008 Apr 28.
Results Reference
derived

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Treatment of Anovulatory Infertility in PCOS Patients

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