Contact information
Type
Scientific
Primary contact
Dr John Nichols
ORCID ID
Contact details
60 Manor Way
Onslow Village
Guildford
GU2 7RR
United Kingdom
+44 (0)1483 564967
drjaan@ntlworld.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2007-6
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Female infertility
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Preconceptional folic acid, Pregnacare Plus
Primary outcome measures
Survival of assisted conception pregnancy to 20 weeks, or failure to conceive and failure of pregnancy to survive to 20 weeks.
Secondary outcome measures
1. Length of pregnancy
2. Birth weight (expressed as percentile birth weight in relation to length of pregnancy)
3. Abdominal circumference
4. Head circumference
Overall trial start date
01/11/2007
Overall trial end date
01/11/2009
Reason abandoned
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
140
Participant exclusion criteria
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
Recruitment start date
01/11/2007
Recruitment end date
01/11/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
60 Manor Way
Guildford
GU2 7RR
United Kingdom
Sponsor information
Organisation
The Royal Surrey County Hospital NHS Trust (UK)
Sponsor details
Egerton Road
Guildford
Surrey
GU2 7RR
United Kingdom
+44 (0)1483 571122
mary.tourette@nhs.net
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The National Institute of Health Research (NIHR) (UK) - Research for Innovation, Speculation and Creativity (RISC) scheme (awaiting outcome of application for funding).
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary