DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



PCOSMIC Trial - PolyCystic Ovary Syndrome, Metformin for Infertility With Clomiphene

Information source: University of Auckland, New Zealand
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Polycystic Ovary Syndrome

Intervention: Metformin (Drug); Placebo (Drug); Metformin + Clomiphene (Drug); Metformin (Drug); Clomiphene (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Auckland, New Zealand

Official(s) and/or principal investigator(s):
Neil P Johnson, FRANZCOG, Principal Investigator, Affiliation: University of Auckland, fertility Plus & Repromed Auckland

Summary

1. Metformin increases the pregnancy rate when added to the standard treatment of anovulatory polycystic ovary syndrome (PCOS). 2. Metformin in combination with clomiphene, is more effective than clomiphene alone or metformin alone improves fertility outcomes in women with PCOS of reasonably healthy body weight (BMI 32 with PCOS.

Clinical Details

Official title: Multi-Centre Randomised Controlled Trial of the Effectiveness of Metformin and Clomiphene Citrate for Treating Anovulatory Infertility in Women With Polycystic Ovary Syndrome

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Clinical pregnancy

Secondary outcome:

Live birth

Adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 39 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Women between the age of 18 and 39 years inclusive.

- Anovulatory infertility of duration at least 12 months.

- Polycystic ovary syndrome, based on Rotterdam consensus criteria.

- Normal serum prolactin, thyroid function and 17-hydroxyprogesterone.

- Normal serum prolactin, thyroid function and 17-hydroxyprogesterone;

Exclusion Criteria:

- Presence of any other significant infertility factor including male factor, known

tubal disease or history of an ectopic pregnancy, known endometriosis affecting the fallopian tubes or ovaries.

- Already taking oral hypoglycaemics.

- Diabetics receiving treatment.

- Renal impairment

- Chronic hepatic disease

- Cardiac Disease

- Alcohol dependency

- Pre-disposition to lactic acidosis

- Previous ovarian drilling procedure, gonadotrophin injection therapy, IUI

(intrauterine insemination) or IVF ( in vitro fertilisation).

- For those women who have had previous fertility treatment, the following would be

excluded:

- Women who have had > 5 cycles of clomiphene citrate

- Women who have had > 5 months metformin treatment previously

- Women who have proven to be resistant to 100mg or more of clomiphene citrate.

Locations and Contacts

University of Auckland, Auckland, New Zealand
Additional Information

Starting date: August 2003
Last updated: November 20, 2008

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017