MedDataX Logo

Study of Time to Pregnancy in Normal Fertility

NCT ID: NCT00161395

Last Updated: 2008-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fertility Pregnancy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

fertility pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Preconception advice.

Group Type ACTIVE_COMPARATOR

Preconception advice

Intervention Type BEHAVIORAL

Preconception advice for diet and frequency of intercourse.

2

Instruction in the Creighton Model Fertility Care System.

Group Type EXPERIMENTAL

Instruction in the Creighton Model Fertility Care System

Intervention Type BEHAVIORAL

Instruction in the Creighton Model Fertility Care System.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Instruction in the Creighton Model Fertility Care System

Instruction in the Creighton Model Fertility Care System.

Intervention Type BEHAVIORAL

Preconception advice

Preconception advice for diet and frequency of intercourse.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fertility awareness instruction.

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

University of Utah

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joseph B Stanford, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Utah, Dept. Family and Preventive Medicine

Salt Lake City, Utah, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Stanford JB, Smith KR, Varner MW. Impact of instruction in the Creighton model fertilitycare system on time to pregnancy in couples of proven fecundity: results of a randomised trial. Paediatr Perinat Epidemiol. 2014 Sep;28(5):391-9. doi: 10.1111/ppe.12141.

Reference Type DERIVED
PMID: 25225008 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K23HD001479

Identifier Type: NIH

Identifier Source: org_study_id

View Link