Time to pregnancy Pregnancy and Childbirth Time to pregnancy
Conditions
Interventions
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
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
Sponsors
Department of Public Health (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 woman?s 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed