A randomised controlled trial to compare conception rates for preconceptional folic acid 400 mg daily versus Pregnacare Plus in assisted conception
| ISRCTN | ISRCTN23488518 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23488518 |
| Secondary identifying numbers | 2007-6 |
- Submission date
- 02/07/2007
- Registration date
- 10/07/2007
- Last edited
- 09/02/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr John Nichols
Scientific
Scientific
60 Manor Way
Onslow Village
Guildford
GU2 7RR
United Kingdom
| Phone | +44 (0)1483 564967 |
|---|---|
| drjaan@ntlworld.com |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Preconceptional folic acid, Pregnacare Plus |
| Primary outcome measure | 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 study start date | 01/11/2007 |
| Completion date | 01/11/2009 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 140 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/11/2007 |
| Date of final enrolment | 01/11/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
60 Manor Way
Guildford
GU2 7RR
United Kingdom
GU2 7RR
United Kingdom
Sponsor information
The Royal Surrey County Hospital NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Egerton Road
Guildford, Surrey
GU2 7RR
England
United Kingdom
| Phone | +44 (0)1483 571122 |
|---|---|
| mary.tourette@nhs.net | |
| Website | http://www.royalsurrey.nhs.uk/Homepage.aspx |
"ROR" |
https://ror.org/050bd8661 |
Funders
Funder type
Government
The National Institute of Health Research (NIHR) (UK) - Research for Innovation, Speculation and Creativity (RISC) scheme (awaiting outcome of application for funding).
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
