Metformin Treatment Before in Vitro Fertilization (IVF) in Women With Ultrasound Evidence of Polycystic Ovaries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2009-05-31

Brief Summary

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The aim of study was to investigate whether pre-treatment with metformin before and during IVF increases the live birth rate compared to placebo in women with sonographic evidence of polycystic ovaries (PCO), but without any clinical manifestations of polycystic ovary syndrome (PCOS).

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Detailed Description

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Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Metformin

Drug (including placebo)

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Women were randomised to receive either metformin or placebo starting three weeks before initiation of a GnRH agonist during an IVF treatment cycle (seven weeks prior to oocyte collection and then stopped at oocyte collection). Seventy identical packs of metformin and 70 identical packs of placebo were supplied by DHP Ltd, Crickhowell, Powys (UK) a commercial clinical trial supplier. The randomisation service was provided by DHP Ltd.

Sugar pill

Drug (including placebo)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Women were randomised to receive either metformin or placebo starting three weeks before initiation of a GnRH agonist during an IVF treatment cycle (seven weeks prior to oocyte collection and then stopped at oocyte collection). Seventy identical packs of metformin and 70 identical packs of placebo were supplied by DHP Ltd, Crickhowell, Powys (UK) a commercial clinical trial supplier. The randomisation service was provided by DHP Ltd.

Interventions

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Metformin

Women were randomised to receive either metformin or placebo starting three weeks before initiation of a GnRH agonist during an IVF treatment cycle (seven weeks prior to oocyte collection and then stopped at oocyte collection). Seventy identical packs of metformin and 70 identical packs of placebo were supplied by DHP Ltd, Crickhowell, Powys (UK) a commercial clinical trial supplier. The randomisation service was provided by DHP Ltd.

Intervention Type DRUG

Placebo

Women were randomised to receive either metformin or placebo starting three weeks before initiation of a GnRH agonist during an IVF treatment cycle (seven weeks prior to oocyte collection and then stopped at oocyte collection). Seventy identical packs of metformin and 70 identical packs of placebo were supplied by DHP Ltd, Crickhowell, Powys (UK) a commercial clinical trial supplier. The randomisation service was provided by DHP Ltd.

Intervention Type DRUG

Eligibility Criteria

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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.

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes