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). |
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Condition | Polycystic Ovary Syndrome |
Intervention | Drug: Metformin Drug: Placebo |
Phase | N/A |
Sponsor | University of Oxford |
Responsible Party | University of Oxford |
ClinicalTrials.gov Identifier | NCT01046032 |
First Received | January 3, 2010 |
Last Updated | January 8, 2010 |
Last verified | January 2010 |
Tracking Information[ + expand ][ + ]
First Received Date | January 3, 2010 |
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Last Updated Date | January 8, 2010 |
Start Date | December 2005 |
Estimated Primary Completion Date | May 2009 |
Current Primary Outcome Measures | Live birth rate [Time Frame: End of pregnancy] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Severe ovarian hyperstimulation syndrome [Time Frame: 2 months] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | Metformin Treatment Before in Vitro Fertilization (IVF) in Women With Ultrasound Evidence of Polycystic Ovaries |
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Official Title | Metformin 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 Description | Not Provided |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment |
Condition | Polycystic Ovary Syndrome |
Intervention | Drug: 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) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 134 |
Estimated Completion Date | May 2009 |
Estimated Primary Completion Date | May 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. |
Gender | Female |
Ages | N/A |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01046032 |
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Other Study ID Numbers | 05/Q1605/87 |
Has Data Monitoring Committee | Yes |
Information Provided By | University of Oxford |
Study Sponsor | University of Oxford |
Collaborators | IVF 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 Date | January 2010 |
Locations[ + expand ][ + ]
IVF Hammersmith | London, United Kingdom |
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Nuture IVF Unit | Nottingham, United Kingdom |
Oxford Fertility Unit | Oxford, United Kingdom, OX39DU |