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ISRCTN
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ISRCTN23488518
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial to compare conception rates for preconceptional folic acid 400 mg daily versus Pregnacare Plus in assisted conception
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Scientific title
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Acronym
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N/A
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Serial number at source
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2007-6
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Study hypothesis
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1. Micronutrient status influences the outcome of pregnancy and normal micronutrient status is necessary for a normal outcome
2. Micronutrient deficiency may prevent assisted conception, or if conception occurs there may be complications including early pregnancy loss and small-for-dates infant at birth
3. Assisted conception subjects who take ten weeks pre-conceptional Pregnacare Plus will produce more pregnancies that survive to 20 weeks than subjects on folic acid 400 mg in sub-fertile patients
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Female infertility
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Participants - inclusion criteria
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1. Sub-fertile subjects scheduled for In Vitro Fertilisation (IVF) or Intra-Uterine Insemination (IUI)
2. Aged less than 35 years
3. Infertility lasting for greater than six months
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Participants - exclusion criteria
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1. Aged greater than 35 years
2. General medical conditions that make a patient unsuitable for assisted conception (i.e. morbid obesity)
3. Women whose understanding of English is insufficient to consent to participation
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Anticipated start date
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01/11/2007
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Anticipated end date
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01/11/2009
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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140
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Interventions
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Randomised controlled trial of folic acid (400 mcg) versus Pregnacare Plus (contains folic acid 400 mcg and 17 other micronutrients) given for 10 weeks prior to assisted conception and follow-up to 20 weeks in those that become pregnant. Subjects will also be monitored for nutritional status.
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Primary outcome measure(s)
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Survival of assisted conception pregnancy to 20 weeks, or failure to conceive and failure of pregnancy to survive to 20 weeks.
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Secondary outcome measure(s)
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1. Length of pregnancy
2. Birth weight (expressed as percentile birth weight in relation to length of pregnancy)
3. Abdominal circumference
4. Head circumference
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Sources of funding
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The National Institute of Health Research (NIHR) (UK) - Research for Innovation, Speculation and Creativity (RISC) scheme (awaiting outcome of application for funding).
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Trial website
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Publications
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Contact name
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Dr
John
Nichols
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Address
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60 Manor Way
Onslow Village
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City/town
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Guildford
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Zip/Postcode
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GU2 7RR
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Country
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United Kingdom
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Tel
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+44 (0)1483 564967
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Fax
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+44 (0)1483 825180
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Email
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drjaan@ntlworld.com
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Sponsor
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The Royal Surrey County Hospital NHS Trust (UK)
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Address
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Egerton Road
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City/town
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Guildford, Surrey
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Zip/Postcode
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GU2 7RR
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Country
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United Kingdom
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Tel
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+44 (0)1483 571122
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Fax
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+44 (0)1483 688660
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Email
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mary.tourette@nhs.net
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Sponsor website:
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http://www.royalsurrey.nhs.uk/Homepage.aspx
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Date applied
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02/07/2007
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Last edited
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09/02/2009
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Date ISRCTN assigned
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10/07/2007
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