Know Cancer

or
forgot password

Metformin Treatment Before IVF in Women With Ultrasound Evidence of Polycystic Ovaries; a Prospective, Randomised, Double Blind, Placebo Study


N/A
N/A
38 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

Thank you

Trial Information

Metformin Treatment Before IVF in Women With Ultrasound Evidence of Polycystic Ovaries; a Prospective, Randomised, Double Blind, Placebo Study


Inclusion Criteria:



- Women attending with ovulatory PCO due to undergo IVF/ICSI treatment.

- First or second cycle of IVF/ICSI.

- If previously on metformin, a minimum one month washout period was required.

- Polycystic ovaries diagnosed by ultrasound presence of ≥12 follicles measuring 2-9 mm
in diameter in at least one ovary and/or increased ovarian volume (≥10 ml).

- Written informed consent.

Exclusion Criteria:

- Clinical manifestations of PCOS, including any of the following:

1. Oligo- or amenorrhoea with cycles ≥42 days apart.

2. Anovulation with mid-luteal progesterone <16 nmol/L.

3. Biochemical hyperandrogenism with serum testosterone ≥3.5 nmol/L and/or free
androgen index >5 (FAI = [total testosterone/SHBG] x 100).

4. Clinical hyperandrogenism with hirsutism or acne requiring treatment at least
weekly.

- Age >38 years.

- BMI >35 kg/m2.

- Basal FSH >12 IU/L.

- Liver disease or ALT >80 IU/L.

- Renal disease, or creatinine >130 nmol/L.

- Alcoholism or drug abuse.

- Diabetes mellitus (evaluated by fasting glucose >6.7mmol/L).

- Per oral steroid treatment in last month.

- Cimetidine, anticoagulation, erythromycin, or other macrolides in last month.

- Hyperprolactinemia (Prolactin >700 mIU/L).

- Abnormal thyroid function tests (TSH outside of laboratory normal range).

- Congenital adrenal hyperplasia.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Live birth rate

Outcome Time Frame:

End of pregnancy

Safety Issue:

No

Principal Investigator

Tim J Child, MA MD MRCOG

Investigator Role:

Study Director

Investigator Affiliation:

University of Oxford

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

05/Q1605/87

NCT ID:

NCT01046032

Start Date:

December 2005

Completion Date:

May 2009

Related Keywords:

  • Polycystic Ovary Syndrome
  • Polycystic ovaries
  • Ovarian stimulation
  • IVF
  • Ovarian hyperstimulation
  • Metformin
  • Polycystic Ovary Syndrome

Name

Location