Condition category
Pregnancy and Childbirth
Date applied
02/07/2007
Date assigned
10/07/2007
Last edited
09/02/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.royalsurrey.nhs.uk/Homepage.aspx

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

Publication citations

Additional files

Editorial Notes