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Trial registered on ANZCTR


Registration number
ACTRN12611000072910
Ethics application status
Approved
Date submitted
8/12/2010
Date registered
19/01/2011
Date last updated
18/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
e-learning for Fertility Awareness
Scientific title
For women aged 18-38, is e-learning of Fertility Awareness successful when compared to a WHO trial of face to face teaching of the Billings Method?
Secondary ID [1] 253263 0
V2010 123 (Australian Catholic University, Human Research Ethics Committee (HREC) Register Number)
Universal Trial Number (UTN)
U1111-1118-4579
Trial acronym
FM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fertility Awareness 258794 0
Condition category
Condition code
Reproductive Health and Childbirth 258937 258937 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a pilot study.
The e-learning application guides the woman to oberve and report her natural fertility symptoms each day. It interprets these symptoms according to the Billings Method, reports her fertility status in Billings Method chart format, and maintains a complete record. After 100 days the particpant will submit her records to the investigators for analysis.
Intervention code [1] 257728 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259797 0
Women being able to enter their fertility symptoms adequately under the guidance from the application. Their descriptions of fertility symptoms will be deemed to be adequate if the pattern recognition algorithm in the e-learning application is able to recognise the Peak of fertiltiy (approximate time of ovulation) in an ovulatory cycle.

The outcome will be assessed by a qualified instructor of the Billings Method at the end of the trial period, using questionnaire, interview and analysis of the reports generated by the application.
Timepoint [1] 259797 0
Continuous during the trial
Secondary outcome [1] 268595 0
Women being able to enter their fertility symptoms adequately under the guidance of the application and to learn to understand their cycles as effectively as they would if under instruction from a Billings Method fertility educator.
The woman will submit a questionnaire and be interviewed by a fertility educator at the end of the trial. An evaluation of her understanding of her patterns of fertility and infertility will be made.


The outcome will be assessed by a qualified instructor of the Billings Method at the end of the trial period, using questionnaire, interview and analysis of the reports generated by the application.
Timepoint [1] 268595 0
Accumulated knowledge over duration of the trial

Eligibility
Key inclusion criteria
proficient in the English language,
Minimum age
18 Years
Maximum age
38 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
pregnant;
using contraceptive medication (e.g. the pill, hormonal implant, hormonal IUD or ovarian stimulant) or devices;

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3506 0
3000 -3999
Recruitment postcode(s) [2] 3507 0
2000-2999

Funding & Sponsors
Funding source category [1] 258186 0
Commercial sector/Industry
Name [1] 258186 0
Webmatics Pty Ltd
Address [1] 258186 0
76 Hawkesbury Cres
Farrer
ACT 2607
Country [1] 258186 0
Australia
Primary sponsor type
Individual
Name
John L Smith
Address
76 Hawkesbury Cres
Farrer
ACT 2607
Country
Australia
Secondary sponsor category [1] 257362 0
None
Name [1] 257362 0
Address [1] 257362 0
Country [1] 257362 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260179 0
Australian Catholic University - Human Research Ethics Committee
Ethics committee address [1] 260179 0
Australian Catholic University Limited
St Patricks Campus
Level 5, 250 Victoria Parade, Fitzroy VIC 3065
Locked Bag 4115, Fitzroy VIC 3065
Ethics committee country [1] 260179 0
Australia
Date submitted for ethics approval [1] 260179 0
15/11/2010
Approval date [1] 260179 0
06/12/2010
Ethics approval number [1] 260179 0
V2010 123

Summary
Brief summary
The hypothesis is that a woman can be guided by an interactive computer application to adequately recognise and record her natural fertility symptoms and that the application can use this knowledge to inform her about fertility awareness according to the Billings Method of natural family planning.

Method:
Women in the age bracket 18-38 will be recruited by advertising.
Participants will download the application software to their PC and follow the guidance system to make thier fertility observations and receive feedback for the next 100 days.
At the end of the 100 day period participants will submit their fertility data for analysis and subsequent interview.
A pilot study involving about 30 participants will be initially undertaken.
Trial website
www.fertilitymentor.org
Trial related presentations / publications
This was a pilot trial and no presentations/publications are anticipated.
Public notes

Contacts
Principal investigator
Name 32003 0
Prof Nicholas Tonti-Filippini
Address 32003 0
John Paul II Institute 278 Victoria Pde East Melbourne VIC 3002
Country 32003 0
Australia
Phone 32003 0
+61 3 9317 4349
Fax 32003 0
Email 32003 0
ntonti-filippini@jp2institute.org
Contact person for public queries
Name 15250 0
Dr John L Smith
Address 15250 0
76 Hawkesbury Cres
Farrer
ACT 2607
Country 15250 0
Australia
Phone 15250 0
+61 2 6286 1720
Fax 15250 0
+61 2 6286 7340
Email 15250 0
JLSMITH@APEX.NET.AU
Contact person for scientific queries
Name 6178 0
Prof Nicholas Tonti-Filippini
Address 6178 0
John Paul II Institute
278 Victoria Pde
East Melbourne
VIC 3002
Country 6178 0
Australia
Phone 6178 0
+61 3 9317 4349
Fax 6178 0
+61 3 9417 2107
Email 6178 0
ntonti-filippini@jp2institute.org

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary