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


Phase 4
18 Years
39 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Clinical pregnancy

Outcome Time Frame:

within 6 calendar months of randomisation

Safety Issue:

No

Principal Investigator

Neil P Johnson, FRANZCOG

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Auckland, fertility Plus & Repromed Auckland

Authority:

New Zealand: Health Research Council

Study ID:

UAuckland

NCT ID:

NCT00795808

Start Date:

August 2003

Completion Date:

October 2008

Related Keywords:

  • Polycystic Ovary Syndrome
  • Polycystic ovary syndrome
  • PCOS
  • Anovulation
  • Infertility
  • Anovulatory polycystic ovary syndrome (PCOS)
  • Infertility
  • Polycystic Ovary Syndrome

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