The Oxford Conception Study - a randomized controlled trial to determine whether daily information about potential fertility from a fertility-monitoring device will increase the conception rate in women wishing to achieve a pregnancy

ISRCTN	ISRCTN69465542
DOI	https://doi.org/10.1186/ISRCTN69465542
Protocol serial number	N/A
Sponsor	Department of Public Health (UK)
Funders	National Health Service Executive (NHSE) National Career Scientist award, National Institute for Childhood Health & Disease US, The DLM Charitable Trust, Unipath non-commercial funding

Submission date: 28/10/2005
Registration date: 02/03/2006
Last edited: 29/08/2018

Recruitment status: No longer recruiting
Overall study status: Completed
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 Cecilia Pyper
Scientific

Department of Public Health
Old road campus
Oxford
OX3 7LF
United Kingdom

Phone	+44 (0)7802 753880
Email	cecilia.pyper@dphpc.ox.ac.uk

Study information

Primary study design	Interventional
Study design	The Oxford Conception Study is a prospective three-arm randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title	The Oxford Conception Study - a randomized controlled trial to determine whether daily information about potential fertility from a fertility-monitoring device will increase the conception rate in women wishing to achieve a pregnancy
Study acronym	OCS
Study objectives	The Oxford Conception Study is a three-arm randomized controlled trial investigating whether daily information about potential fertility from a digital fertility-monitoring device will increase the conception rate in women wishing to achieve a pregnancy. A third of women are randomized to receive information about the early fertile time, a third of women are randomized to receive information about the late fertile time and third are a control group who do not receive any information. The women are followed up for six months or until they are pregnant. The primary outcome is to compare the cumulative three-cycle pregnancy rate between women using a modified fertility monitor when the monitor displays high fertility from the first appearance of Luteinizing hormone (LH) and for the next two days, (i.e. the days that identify the late fertile time) and women using a modified fertility monitor which gives no fertile status.
Ethics approval(s)	Ethics approval for the Oxford Conception Study was received in September 2002, reference number CO1.282
Health condition(s) or problem(s) studied	Time to pregnancy
Intervention	Three modified versions of a fertility monitor (supplied by Unipath Ltd. and currently not available in the UK, have been developed for the study so that the daily result for potential fertility will be displayed (or not) according to the experimental design. The monitor allows the womans fertility status to be assessed independently. For the purpose of this trial, the fertility monitor is set to request all the women to test their urine on 20 days of the cycle from day 6 to day 25 inclusive. The fertility monitor identifies a womans fertile period by measuring via immunochromatography the levels of estrone-3 glucuronide (E3G), a metabolite of estrogen, and LH in urine. A recent independent study has demonstrated that the LH surge accurately predicts the day of ovulation. The trial has two intervention arms and a control arm. Volunteers are randomized to one of the three arms using computer generated random numbers. The randomization method uses opaque sealed envelopes. The volunteers are randomized into one of three groups; each group receives different information from the fertility monitor: 1. The late fertile time group: monitor shows high fertility from the first appearance of LH and for the next two days. It then shows low fertility until the end of the menstrual cycle 2. The early fertile time group: monitor shows high fertility from the first appearance of E3G and low fertility from the appearance of LH until the end of the menstrual cycle 3. The control group: monitor reveals no information about the fertility status although they still perform urine tests on 20 days of the cycle as requested
Intervention type	Device
Phase	Not Specified
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	The primary outcome measure is whether the pregnancy rate (assessed in terms of 3-month and 6-month cumulative pregnancy rates) in couples given information about the womans potential fertility is higher than those who do not receive the information. The women in the late fertile group (LH day + 2 days) will be compared with women in the control group. The days of intercourse and the monthly conception rates will be compared between those in the late fertile group who receive daily information from the monitors and those who do not.
Key secondary outcome measure(s)	Secondary outcome questions include: 1. Whether the pregnancy rate (assessed in terms of 3-month & 6-month cumulative pregnancy rates) in the women in the early fertile group (E3G until LH rise) is higher than that of the pregnancy rate of the women in the control group 2. Whether the pregnancy rate (assessed in terms of 3-month & 6-month cumulative pregnancy rates) in the late fertile group (LH day + 2 days) is higher than that of the women in the early fertile group (E3G until LH rise) 3. Whether information from a fertility-monitoring device helps couples to target sexual intercourse more effectively than no information 4. Whether there is an association between the following variables on conception rates and pregnancy outcome: age of woman, age of partner, Hospital Anxiety And Depression (HAD) score, stress scores, salivary cortisol, salivary amylase, Body Mass Index (BMI) of women, smoking, alcohol, caffeine intake, vitamin supplementation, medication consumption, age of the gametes, intercourse frequency, cycle length variability
Completion date	01/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	1350
Key inclusion criteria	1. Women aged 18 to 40 years who are having sexual intercourse with a regular partner 2. Trying to conceive for less than three months 3. Menstrual cycle length of 21 to 35 days for the past three months 4. Willing to record all medication use and sexual intercourse during the study 5. Willing to travel to Oxford for one recruitment session or agree to phone recruitment 6. Willing to be randomized into one of three groups 7. Willing to have a baseline pregnancy test to ensure that they are not pregnant at entry
Key exclusion criteria	1. Either partner has a history of infertility or is currently undergoing infertility treatment 2. Either partner is using any form of contraception 3. Woman is breastfeeding 4. Woman has used hormonal contraception during the past three menstrual cycles 5. Woman has used emergency contraception in the past two menstrual cycles 6. Woman has used injectable contraceptive in the past year
Date of first enrolment	01/11/2003
Date of final enrolment	01/12/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Public Health

Oxford
OX3 7LF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	01/11/2006		Yes	No

Editorial Notes

29/08/2018: No publications found, verifying study status with principal investigator