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

Overview[ - collapse ][ - ]

Purpose 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).
ConditionPolycystic Ovary Syndrome
InterventionDrug: Metformin
Drug: Placebo
PhaseN/A
SponsorUniversity of Oxford
Responsible PartyUniversity of Oxford
ClinicalTrials.gov IdentifierNCT01046032
First ReceivedJanuary 3, 2010
Last UpdatedJanuary 8, 2010
Last verifiedJanuary 2010

Tracking Information[ + expand ][ + ]

First Received DateJanuary 3, 2010
Last Updated DateJanuary 8, 2010
Start DateDecember 2005
Estimated Primary Completion DateMay 2009
Current Primary Outcome MeasuresLive birth rate [Time Frame: End of pregnancy] [Designated as safety issue: No]
Current Secondary Outcome MeasuresSevere ovarian hyperstimulation syndrome [Time Frame: 2 months] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleMetformin Treatment Before in Vitro Fertilization (IVF) in Women With Ultrasound Evidence of Polycystic Ovaries
Official TitleMetformin Treatment Before IVF in Women With Ultrasound Evidence of Polycystic Ovaries; a Prospective, Randomised, Double Blind, Placebo Study
Brief Summary
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).
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
ConditionPolycystic Ovary Syndrome
InterventionDrug: 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.
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.
Study Arm (s)
  • Active Comparator: Metformin
    Drug (including placebo)
  • Placebo Comparator: Sugar pill
    Drug (including placebo)

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment134
Estimated Completion DateMay 2009
Estimated Primary Completion DateMay 2009
Eligibility Criteria
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.
GenderFemale
AgesN/A
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesUnited Kingdom

Administrative Information[ + expand ][ + ]

NCT Number NCT01046032
Other Study ID Numbers05/Q1605/87
Has Data Monitoring CommitteeYes
Information Provided ByUniversity of Oxford
Study SponsorUniversity of Oxford
CollaboratorsIVF Hammersmith; Imperial College London
Nuture IVF Nottingham; University of Nottingham
Investigators Study Director: Tim J Child, MA MD MRCOG University of OxfordPrincipal Investigator: Alexander G Swanton, MBBS MRCOG University of Oxford
Verification DateJanuary 2010

Locations[ + expand ][ + ]

IVF Hammersmith
London, United Kingdom
Nuture IVF Unit
Nottingham, United Kingdom
Oxford Fertility Unit
Oxford, United Kingdom, OX39DU