| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN23488518 |
| Date ISRCTN assigned | 10/07/2007 |
| Local reference number(s) | 2007-6 |
| Public title | A randomised controlled trial to compare conception rates for preconceptional folic acid 400 mg daily versus Pregnacare Plus in assisted conception |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Female infertility |
| 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 |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Applied to Surrey Research Ethics Committee, pending as of 10/07/2007. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material |
|
| Anticipated start date | 01/11/2007 |
| Anticipated end date | 01/11/2009 |
| Status of trial | Ongoing |
| Target number of participants | 140 |
| Interventions | 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. |
| Primary outcome measure(s) | Survival of assisted conception pregnancy to 20 weeks, or failure to conceive and failure of pregnancy to survive to 20 weeks. |
| Secondary outcome measure(s) | 1. Length of pregnancy
2. Birth weight (expressed as percentile birth weight in relation to length of pregnancy)
3. Abdominal circumference
4. Head circumference |
| Sources of funding | The National Institute of Health Research (NIHR) (UK) - Research for Innovation, Speculation and Creativity (RISC) scheme (awaiting outcome of application for funding). |
| Sponsor name | The Royal Surrey County Hospital NHS Trust (UK) |
| Sponsor details | Egerton Road
Guildford, Surrey
United Kingdom
GU2 7RR |
| Sponsor telephone | +44 (0)1483 571122 |
| Sponsor fax | +44 (0)1483 688660 |
| Sponsor email | mary.tourette@nhs.net |
| Sponsor website | http://www.royalsurrey.nhs.uk/Homepage.aspx |
| Contact name | Dr John Nichols |
| Contact details | 60 Manor Way
Onslow Village
Guildford
United Kingdom
GU2 7RR |
| Contact telephone | +44 (0)1483 564967 |
| Contact fax | +44 (0)1483 825180 |
| Contact email | drjaan@ntlworld.com |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN23488518 |
| Date last extracted from ISRCTN register | 17/04/2008 |
