Comparison of Two Internet Supported Natural Family Planning Methods
Condition: Pregnancy
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

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?
    

Intervention name(s): Electronic hormonal fertility monitoring; Self-monitoring
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; Self-monitoring of externally observed cervical mucus to determine level of fertility.
Other intervention name(s): ClearBlue Easy Fertility Monitor (Unipath, LTD).; Ovulation method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: fertility monitoring; contraception