Study of Time to Pregnancy in Normal Fertility

Study Overview
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Brief Summary
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The purpose of this study is to determine how long it takes couples of normal fertility to get pregnant once they begin to try, and whether instruction in fertility awareness can decrease time to pregnancy in these couples.

Detailed Description
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Research has established that there are relatively few days of the menstrual cycle that have a substantial probability of pregnancy from coitus, and that there are prospective biomarkers that allow a woman or couple to identify these fertile days. However, it remains unclear how this knowledge may improve a couple's chances of conceiving. All couples participating in this study must have a history of previous pregnancy together and no history suggesting subfertility. Participants in this study will be randomly assigned to one of two groups. One group will receive instruction about identifying the days when a woman is mostly likely to get pregnant from intercourse, using the Creighton Model FertilityCare System, and the other group will receive instructions about the menstrual cycle, fertility, and preparing for pregnancy. Randomization is stratified by age. All participants will keep a daily fertility chart and use a computerized device called the Fertility Monitor with urine dipsticks to monitor hormones of the menstrual cycle. The primary outcome is time to pregnancy.

Official Title
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Randomized Trial of Fertility Awareness and Time to Pregnancy in Couples of Normal Fertility

Conditions
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Fertility, Pregnancy

Intervention / Treatment
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* Behavioral: Instruction in the Creighton Model Fertility Care System
* Behavioral: Preconception advice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: couple with prior pregnancy within the past 8 years Exclusion Criteria: any history that suggests subfertility any history that suggests a medical contraindication for pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Preconception advice. | Behavioral: Preconception advice<br>* Preconception advice for diet and frequency of intercourse.<br>|
| Experimental: 2<br>Instruction in the Creighton Model Fertility Care System. | Behavioral: Instruction in the Creighton Model Fertility Care System<br>* Instruction in the Creighton Model Fertility Care System.<br>* Other names: Fertility awareness instruction.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Pregnancy |  | Up to one year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of coitus within fertile days of menstrual cycle |  | Seven menstrual cycles. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fertility, pregnancy