Back to results

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

Primary Purpose

Polycystic Ovary Syndrome

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Metformin

Placebo

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovaries, Ovarian stimulation, IVF, Ovarian hyperstimulation, Metformin

Eligibility Criteria

undefined - 38 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

IVF Hammersmith
Nuture IVF Unit
Oxford Fertility Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Metformin

Sugar pill

Arm Description

Drug (including placebo)

Outcomes

Primary Outcome Measures

Live birth rate

Secondary Outcome Measures

Severe ovarian hyperstimulation syndrome

Full Information

NCT ID

NCT01046032

First Posted

January 3, 2010

Last Updated

January 8, 2010

Sponsor

University of Oxford

Collaborators

Imperial College London, University of Nottingham

1. Study Identification

Unique Protocol Identification Number

NCT01046032

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Oxford

Collaborators

Imperial College London, University of Nottingham

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

Keywords

Polycystic ovaries, Ovarian stimulation, IVF, Ovarian hyperstimulation, Metformin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

134 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metformin

Arm Type

Active Comparator

Arm Description

Drug (including placebo)

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Arm Description

Drug (including placebo)

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

Primary Outcome Measure Information:

Title

Live birth rate

Time Frame

End of pregnancy

Secondary Outcome Measure Information:

Title

Severe ovarian hyperstimulation syndrome

Time Frame

2 months

10. Eligibility

Sex

Female

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

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: Oligo- or amenorrhoea with cycles ≥42 days apart. Anovulation with mid-luteal progesterone <16 nmol/L. Biochemical hyperandrogenism with serum testosterone ≥3.5 nmol/L and/or free androgen index >5 (FAI = [total testosterone/SHBG] x 100). 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tim J Child, MA MD MRCOG

Organizational Affiliation

University of Oxford

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Alexander G Swanton, MBBS MRCOG

Organizational Affiliation

University of Oxford

Official's Role

Principal Investigator

Facility Information:

Facility Name

IVF Hammersmith

City

London

Country

United Kingdom

Facility Name

Nuture IVF Unit

City

Nottingham

Country

United Kingdom

Facility Name

Oxford Fertility Unit

City

Oxford

ZIP/Postal Code

OX39DU

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

16501038

Citation

Tang T, Glanville J, Orsi N, Barth JH, Balen AH. The use of metformin for women with PCOS undergoing IVF treatment. Hum Reprod. 2006 Jun;21(6):1416-25. doi: 10.1093/humrep/del025. Epub 2006 Feb 24.

Results Reference

background

PubMed Identifier

15117902

Citation

Kjotrod SB, von During V, Carlsen SM. Metformin treatment before IVF/ICSI in women with polycystic ovary syndrome; a prospective, randomized, double blind study. Hum Reprod. 2004 Jun;19(6):1315-22. doi: 10.1093/humrep/deh248. Epub 2004 Apr 29.

Results Reference

background

PubMed Identifier

21593045

Citation

Swanton A, Lighten A, Granne I, McVeigh E, Lavery S, Trew G, Talmor A, Raine-Fenning N, Jayaprakasan K, Child T. Do women with ovaries of polycystic morphology without any other features of PCOS benefit from short-term metformin co-treatment during IVF? A double-blind, placebo-controlled, randomized trial. Hum Reprod. 2011 Aug;26(8):2178-84. doi: 10.1093/humrep/der120. Epub 2011 May 18.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs