Strategies for Ovulation Induction in Anovulatory Infertile Patients With PCOS

NCT ID: NCT00461643

Last Updated: 2013-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 552 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31

Brief Summary

Anovulatory infertility is a common feature of the polycystic ovary syndrome (PCOS). Even if several first-step treatments have been proposed for anovulatory infertile PCOS patients, very few data are available in literature regarding the best integrated strategy. In fact, a single compound could be effective as first-step approach but not or less useful when integrated in a more complex strategy.

The goal of the current protocol will be to compare three different strategies for treating anovulatory infertility in PCOS patients having as primary end-point the multiple pregnancy rate.

Detailed Description

All patients eligible will undergo baseline assessment consisting of antropometric, hormonal, and ultrasonographic assessments. Successively, patients enrolled will be allocated in three different strategies (strategy A, B, and C).

A total of 184 infertile PCOS patients per arm will be enrolled and treated with three different integrated strategies: clomiphene followed by clomiphene plus metformin followed by gonadotropins (strategy A); metformin followed by metformin plus clomiphene followed by gonadotropins(strategy B); and metformin plus clomiphene followed by gonadotropins(strategy C).

In all patients, the same regimen will be used to administered clomiphene, metformin, and gonadotropins.Both clomiphene and metformin will be administered at incremental doses in each case.Gonadotropins will be administrated to obtain a controlled ovarian stimulation using highly purified urinary FSH in a low-dose step-up protocol.

During the study, the clinical and reproductive outcomes, and adverse experiences will be evaluated in each woman.

Conditions

Anovulatory Infertility Related to Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Strategy A

clomiphene followed by clomiphene plus metformin followed by gonadotropins

Group Type: ACTIVE_COMPARATOR

Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins

Intervention Type: DRUG

Strategy B

metformin followed by metformin plus clomiphene followed by gonadotropins

Group Type: ACTIVE_COMPARATOR

Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins

Intervention Type: DRUG

Strategy C

metformin plus clomiphene followed by gonadotropins

Group Type: ACTIVE_COMPARATOR

Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins

Intervention Type: DRUG

Interventions

Clomiphene citrate, metformin, metformin plus clomiphene citrate, gonadotropins

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Polycystic ovary syndrome (using ESHRE/ARSM 2004 criteria)

Exclusion Criteria

• 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
• Previous use of ovulation induction agents
• Intention to start a diet or a specific program of physical activity
• No uterine bleeding after progesterone challenge test
• Organic pelvic diseases
• Previous pelvic surgery
• Suspected peritoneal factor infertility
• Tubal or male factor infertility or sub-fertility

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Magna Graecia

OTHER

Sponsor Role: lead

Responsible Party

Stefano Palomba

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefano Palomba, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

"Pugliese" Hospital

Catanzaro, , Italy

Site Status: RECRUITING

"Pugliese" Hospital

Catanzaro, , Italy

Site Status: RECRUITING

Pugliese-Ciaccio Hospital

Catanzaro, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Stefano Palomba, MD

Role: CONTACT

stefanopalomba@tin.it

+39-0961.883234

Facility Contacts

Ingrid Tomaino, MD

Role: primary

angela.falbo@libero.it

+39 0961 883234

Ingrid Tomaino, MD

Role: primary

zullo@unicz.it

+39 0961 883234

MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 15840746 (View on PubMed)

Moll E, Bossuyt PM, Korevaar JC, Lambalk CB, van der Veen F. Effect of clomifene citrate plus metformin and clomifene citrate plus placebo on induction of ovulation in women with newly diagnosed polycystic ovary syndrome: randomised double blind clinical trial. BMJ. 2006 Jun 24;332(7556):1485. doi: 10.1136/bmj.38867.631551.55. Epub 2006 Jun 12.

Reference Type: BACKGROUND

PMID: 16769748 (View on PubMed)

Legro RS, Barnhart HX, Schlaff WD, Carr BR, Diamond MP, Carson SA, Steinkampf MP, Coutifaris C, McGovern PG, Cataldo NA, Gosman GG, Nestler JE, Giudice LC, Leppert PC, Myers ER; Cooperative Multicenter Reproductive Medicine Network. Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome. N Engl J Med. 2007 Feb 8;356(6):551-66. doi: 10.1056/NEJMoa063971.

Reference Type: BACKGROUND

PMID: 17287476 (View on PubMed)

Other Identifiers

01/2007

Identifier Type: -

Identifier Source: org_study_id