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Trial registered on ANZCTR


Registration number
ACTRN12612000164897
Ethics application status
Approved
Date submitted
3/02/2012
Date registered
6/02/2012
Date last updated
11/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Does monitoring fertile times of the menstrual cycle help subfertile couples achieve a pregnancy?
Scientific title
In women with unexplained subfertility, does a fertility awareness-based charting method compared to generic fertility instruction increase the likelihood of pregnancy?
Secondary ID [1] 279857 0
Nil
Universal Trial Number (UTN)
U1111-1120-7666
Trial acronym
Pregnancy Achieving Trial – PATrial 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unexplained subfertility 285742 0
Condition category
Condition code
Reproductive Health and Childbirth 285928 285928 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Instruction (presented as a face-to-face session for approximately 40 minutes) in the Sympto-Thermal charting Method lasting, documented on a temperature/mucus chart for up to 8 months.
This will occur in addition to the instruction in fertility awareness (group session for 20 minutes) that both trial arms will receive.
Intervention code [1] 284175 0
Other interventions
Comparator / control treatment
Instruction in fertility awareness (presented as a group session for approximately 20 minutes); the first day of each menstrual cycle documented on a calendar for up to 8 months.
Control group
Active

Outcomes
Primary outcome [1] 286417 0
Positive pregnancy test.

This is defined as HCG > 25 mIU/L. This test is either a quantitative serum level or a qualitative urine point of care test (which becomes positive at a level of 25 mIU/L).
Timepoint [1] 286417 0
Pregnancy test is to be performed in the setting of a clinically missed period (for those charting this is 16 days after peak mucus sign or 15 days of sustained temperature shift) for up to 8 months
Secondary outcome [1] 295813 0
Time to conception
Timepoint [1] 295813 0
Diagnosis of pregnancy for up to 8 months
Secondary outcome [2] 295814 0
Live birth rate
Timepoint [2] 295814 0
Completion of index pregnancy
Secondary outcome [3] 295815 0
Miscarriage rate
Timepoint [3] 295815 0
Completion of index pregnancy
Secondary outcome [4] 295816 0
Gestation and weight at birth
Timepoint [4] 295816 0
Completion of index pregnancy
Secondary outcome [5] 295817 0
Accuracy of method in determining expected date of confinement
Timepoint [5] 295817 0
Completion of index pregnancy
Secondary outcome [6] 295818 0
DASS 21 scores - screening tool for depression, anxiety and stress
Timepoint [6] 295818 0
Diagnosis of pregnancy for up to 8 months OR at completion of trial at 8 months if not pregnant
Secondary outcome [7] 295819 0
Acceptability of intervention - by way of an acceptability survey tool
Timepoint [7] 295819 0
Diagnosis of pregnancy for up to 8 months OR at completion of trial at 8 months if not pregnant

Eligibility
Key inclusion criteria
1. Women with a normal hormonal profile in the luteal phase of the menstrual cycle AND
A. Women failing to achieve a pregnancy after 12 months of unprotected random intercourse OR
B. Women failing to achieve an ongoing pregnancy (greater than 20 weeks) after 12 months of unprotected random intercourse OR
c. Women with a history of 3 or more miscarriages
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Subfertility is due to tubal causes (defined as abnormal hysterosalpingography and/or laparoscopy & dye insufflation, and/or hysterosalpingography with contrast by sonography (HyCoSy))
2. Subfertility is due to male factor (absence of a normal /effective seminal fluid analysis within last six months (WHO criteria))
3. Women who are exclusively breastfeeding
4. Currently using contraception
5. Currently pregnant
6. Currently using any prescribed fertility-enhancing medications or supplements, including Vitex agnus
7. Women who have ever used a fertility awareness-based method

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Standardised preconception care clinic, Standardised subfertility medical work-up.
Unexplained subfertility determined, informed of trial, luteal phase serial assessment, meet criteria.
Consented, enrolled, participate in standardised group anatomy, physiology and fertility awareness instruction then allocation by sealed opaque envelopes.
Standardised instruction in STM charting or menstrual cycle awareness.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated variable block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)

Funding & Sponsors
Funding source category [1] 284630 0
Hospital
Name [1] 284630 0
Mater Mothers' Hospital
Address [1] 284630 0
Mater Health Services
Raymond Terrace
South Brisbane
Queensland 4101
Country [1] 284630 0
Australia
Primary sponsor type
Individual
Name
Dr Luke McLindon
Address
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
Queensland 4101
Country
Australia
Secondary sponsor category [1] 283543 0
Hospital
Name [1] 283543 0
Mater Mothers' Hospital
Address [1] 283543 0
Raymond Terrace
South Brisbane
Queensland 4101
Country [1] 283543 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286621 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 286621 0
Mater Health Services
Raymond Terrace
South Brisbane
Queensland 4101
Ethics committee country [1] 286621 0
Australia
Date submitted for ethics approval [1] 286621 0
Approval date [1] 286621 0
15/12/2010
Ethics approval number [1] 286621 0
EC00332

Summary
Brief summary
This project will assess the effectiveness of a fertility awareness-based charting method in increasing the likelihood of pregnancy in a population with unexplained subfertility.

It is hypothesised that the Sympto-Thermal Method increases the likelihood of pregnancy in the unexplained ovulating subfertile population.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33722 0
Address 33722 0
Country 33722 0
Phone 33722 0
Fax 33722 0
Email 33722 0
Contact person for public queries
Name 16969 0
Clinical Midwife
Address 16969 0
Fertility Assessment and Research Clinic
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
Queensland 4101
Country 16969 0
Australia
Phone 16969 0
61 7 3163 8437
Fax 16969 0
61 7 3163 2137
Email 16969 0
naturalfertility@mater.org.au
Contact person for scientific queries
Name 7897 0
Dr Luke McLindon
Address 7897 0
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
Queensland 4101
Country 7897 0
Australia
Phone 7897 0
61 7 3163 8111
Fax 7897 0
Email 7897 0
lucas.mclindon@mater.org.au

No information has been provided regarding IPD availability
Summary results
No Results