Comparison of Two Internet Supported Natural Family Planning Methods

September 22, 2015 updated by: Richard J. Fehring, Marquette University

Randomized Comparison of Two Internet Supported Natural Family Planning Methods

The purpose of this research study is to compare the effectiveness of two natural family planning (NFP) methods that are provided over the internet by the Marquette University Institute for Natural Family Planning. One of the NFP methods is the use of a hand held electronic hormonal fertility monitor. The other method involves the self-observation of cervical mucus to track fertility. Both of the methods will involve placing information about fertility into an online charting system that automatically displays the days of fertility and infertility. The investigators are also interested in the influence of mutual motivation by the woman and her partner in using these methods to avoid pregnancy. The investigators hypothesize that there will be lower unintended pregnancy rates among those couples who use the electronic hormonal fertility monitor and among those couples who have a strong motivation to avoid pregnancy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Office of Population Affairs (OPA) of the Department of Human Development recently submitted a call for proposals for research on methods of natural family planning (NFP). The department chairs of OPA have recognized that relatively few women in the United States use natural methods of family planning, especially in the Title X Family Planning programs and clinics. They wanted researchers to develop studies to help increase the use and the efficacy of these methods, and, furthermore, wanted to understand why the methods are not used more. Reasons why only about 0.2% of US women use natural methods of birth control are they are often difficult to use, they are relatively ineffective, and there is a lack of access to properly trained NFP teachers. At Marquette University we have developed simple methods of NFP that utilize an electronic fertility monitor that measures female reproductive hormones, self cervical mucus monitoring that estimates the fertile window, and a simple fertility formula to help estimate the beginning and end of the fertile window. We also have developed a Web site that offers easy access to information on NFP, electronic charting, and professional nurses with specialization in teaching NFP.

The specific purpose of our study is to determine the efficacy, satisfaction, ease of use, and motivation in using an internet based NFP method that utilizes an electronic hormonal fertility monitor plus a simple fertility formula (i.e., EHFM-NFP) within an online professional-nurse supported system. Since there are few studies that compare methods of NFP, another aim of this study is to compare an internet based EFHM-NFP method with an internet based traditional cervical mucus monitoring (CMM) NFP method - both methods were developed at Marquette University. Please note that we have 3 published efficacy studies of the Marquette Method.

The specific research questions that will be asked are:

  1. What are the 3, 6, and 12-month unintended pregnancy rates of an internet-provided EHFM-aided NFP method?
  2. What are the 3, 6, and 12-month unintended pregnancy rates of an internet-provided CMM-only NFP method?
  3. What is the satisfaction, ease of use, and mutual motivation of an internet-based NFP method (either EFHM or CMM) over a 12-month time period, i.e., after 1, 3, 6, and 12 months of use?

Study Type

Interventional

Enrollment (Actual)

358

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53201-1881
        • Marquette University
      • Milwaukee, Wisconsin, United States, 53201-1881
        • Marquette University College of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For Female participants

Inclusion Criteria:

  • be between the age of 18 and 42
  • be in a sexually active committed relationship with a man
  • have a menstrual cycle range of 21-42 days

Exclusion Criteria:

  • have not used Depo (injectable) contraception for the past 6 months
  • have not used oral or patch hormonal contraception for the past 3 months
  • have not breast-fed baby for at least three months
  • have no known fertility problems
  • not be using medications that interfere with fertility
  • not smoke cigarettes; and
  • not be pregnant.

For Male Participants

Inclusion criteria:

  • be between the ages of 18 and 50
  • be in a sexually active committed relationship with his lone woman partner.

Exclusion criteria:

  • have no known fertility problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electronic hormonal fertility monitoring
Use of an electronic hormonal fertility monitor that measures urinary estrogen and LH and provides users with low, high, or peak fertility readings.
Behavioral: Electronic hormonal fertility monitoring
Use of an electronic hormonal fertility monitor that provides three levels of fertility; low, high, and peak. Monitor is based upon urinary levels of E3G (estrogen) and LH. Monitor readings are placed in an electronic charting system on the Internet.
Other Names:
  • ClearBlue Easy Fertility Monitor (Unipath, LTD).
Active Comparator: Cervical mucus monitoring
Self-monitoring of externally observed cervical mucus to determine level of fertility.
Behavioral: Self-monitoring
Self-monitoring of externally observed cervical mucus to determine level of fertility.
Other Names:
  • Ovulation method

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unintended Pregnancies
Time Frame: 1, 3, 6, and 12 months
Survival analysis of based on unintended pregnancies and correct use menstrual cycles (for perfect use analysis) and typical use (based on total number of menstrual cycles) -- to be calculated at 1, 3, 6, and 12 months of use. A Kaplan-Meier survival curve over that time period will be displayed to show change.
1, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
user satisfaction, ease of use, mutual motivation
Time Frame: 1, 3, 6 and 12 months; mutual motivation monthly
To determine if there is significant change from baseline (at 1 month) to 3, 6 and 12 months in the outcome measure of "satisfaction and ease of use" - repeated measure analysis (ANOVA) will be used. Change in motivation to avoid pregnancy from baseline (i.e., before charting the first menstrual cycle) through 12 months of use will also be analyzed for changes by repeated measure analysis. We will also use repeated measure analysis to determine differences in the outcome measures between the two study groups.
1, 3, 6 and 12 months; mutual motivation monthly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marquette University

Investigators

  • Principal Investigator: Richard J Fehring, PhD, Marquette University College of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 12, 2009

First Posted (Estimate)

February 13, 2009

Study Record Updates

Last Update Posted (Estimate)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FPR200801363

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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