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Study of Time to Pregnancy in Normal Fertility

Utah System of Higher Education (USHE) logo

Utah System of Higher Education (USHE)

Status and phase

Completed
Phase 2

Conditions

Fertility
Pregnancy

Treatments

Behavioral: Preconception advice
Behavioral: Instruction in the Creighton Model Fertility Care System

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00161395
K23HD001479

Details and patient eligibility

About

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.

Full description

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.

Enrollment

143 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

143 participants in 2 patient groups

1
Active Comparator group
Description:
Preconception advice.
Treatment:
Behavioral: Preconception advice
2
Experimental group
Description:
Instruction in the Creighton Model Fertility Care System.
Treatment:
Behavioral: Instruction in the Creighton Model Fertility Care System

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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