Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000166875
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 progesterone support in luteal phase deficiency help subfertile couples achieve a pregnancy?
Scientific title
In women with unexplained subfertility and luteal phase deficiency, does luteal phase support with progesterone while using a fertility awareness-based charting method when compared to fertility awareness-based charting alone increase the likelihood of pregnancy?
Secondary ID [1] 279856 0
Nil
Universal Trial Number (UTN)
U1111-1120-8785
Trial acronym
Pregnancy Achieving Trial 2 (PATrial 2)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unexplained subfertility 285754 0
Luteal Phase Defect 285755 0
Condition category
Condition code
Reproductive Health and Childbirth 285933 285933 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Progesterone pessaries (400 mg vaginally nightly) during each luteal phase (used for 10 consecutive nights), for up to 8 months/cycles.

Formal instruction in the Sympto-Thermal Method is routinely provided.
Intervention code [1] 284180 0
Treatment: Drugs
Comparator / control treatment
Placebo vaginal pessaries during each luteal phase (used for 10 consecutive nights), for up to 8 months.

Formal instruction in the Sympto-Thermal Method is routinely provided.
Control group
Placebo

Outcomes
Primary outcome [1] 286422 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] 286422 0
Pregnancy test is to be performed in the setting of a clinically missed period (16 days after peak mucus sign or 15 days of sustained temperature shift in this population charting their menstrual cycle) for up to 8 months
Secondary outcome [1] 295830 0
Time to conception
Timepoint [1] 295830 0
Diagnosis of pregnancy for up to 8 months
Secondary outcome [2] 295831 0
DASS 21 scores - screening for depression, anxiety and stress
Timepoint [2] 295831 0
Diagnosis of pregnancy for up to 8 months OR at completion of trial (8 months) if not pregnant
Secondary outcome [3] 295832 0
Acceptability of intervention - by way of an acceptability survey tool
Timepoint [3] 295832 0
Diagnosis of pregnancy for up to 8 months OR at completion of trial (8 months) if not pregnant
Secondary outcome [4] 295833 0
Live birth rate
Timepoint [4] 295833 0
Completion of index pregnancy
Secondary outcome [5] 295834 0
Miscarriage rate
Timepoint [5] 295834 0
Completion of index pregnancy
Secondary outcome [6] 295835 0
Gestation and weight at birth
Timepoint [6] 295835 0
Completion of index pregnancy
Secondary outcome [7] 295836 0
Congenital anomalies
Timepoint [7] 295836 0
Completion of index pregnancy
Secondary outcome [8] 295837 0
Neonatal morbidity composite - nursery admission for any reason, and to include intraventricular haemorrhage, respiratory distress syndrome, necrotising enterocolitis
Timepoint [8] 295837 0
Up to 4 weeks post delivery
Secondary outcome [9] 295838 0
Maternal morbidity composite - to include antepartum haemorrhage, gestational hypertension, pre-eclampsia, gestational diabetes, venothromboembolic events, postnatal depression
Timepoint [9] 295838 0
Conception to 4 weeks post delivery

Eligibility
Key inclusion criteria
1. Luteal phase hormonal defect (based on oestradiol and progesterone serum levels drawn on days 5, 7 and 9 post-ovulation) AND
A. Failing to achieve a pregnancy after 12 months of unprotected random intercourse OR
B. Failing to achieve an ongoing pregnancy (greater than 20 weeks) after 12 months of unprotected random intercourse OR
C. A history of 3 or more miscarriages
Minimum age
18 Years
Maximum age
No limit
Sex
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

Study design
Purpose of the study
Treatment
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.
Participate in standardised Sympto-Thermal Method instruction.
'Script' given, dispensed as blinded therapy at the pharmacy according to randomisation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated variable block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284632 0
Hospital
Name [1] 284632 0
Mater Mothers' Hospital
Country [1] 284632 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] 283545 0
Hospital
Name [1] 283545 0
Mater Mothers' Hospital
Address [1] 283545 0
Raymond Terrace
South Brisbane
Queensland 4101
Country [1] 283545 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286625 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 286625 0
Mater Health Services
Raymond Terrace
South Brisbane
Queensland 4101
Ethics committee country [1] 286625 0
Australia
Date submitted for ethics approval [1] 286625 0
Approval date [1] 286625 0
15/12/2010
Ethics approval number [1] 286625 0
EC00332

Summary
Brief summary
This project aims to assess the effectiveness of progesterone as luteal phase support in unexplained subfertile women with a previously diagnosed luteal phase hormonal deficiency.

All women will be instructed in a fertility awareness-based charting method (the Sympto-Thermal method).

It is hypothesised that progesterone given as luteal phase support increases the likelihood of pregnancy in unexplained subfertile women with a recognised luteal phase hormonal defect.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33721 0
Address 33721 0
Country 33721 0
Phone 33721 0
Fax 33721 0
Email 33721 0
Contact person for public queries
Name 16968 0
Clinical Midwife
Address 16968 0
Fertility Assessment and Research Clinic
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
Queensland 4101
Country 16968 0
Australia
Phone 16968 0
61 7 3163 8437
Fax 16968 0
61 7 3163 2137
Email 16968 0
[email protected]
Contact person for scientific queries
Name 7896 0
Dr Luke McLindon
Address 7896 0
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
Queensland 4101
Country 7896 0
Australia
Phone 7896 0
61 7 3163 8111
Fax 7896 0
Email 7896 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.