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Trial registered on ANZCTR


Registration number
ACTRN12612000174886
Ethics application status
Approved
Date submitted
3/02/2012
Date registered
8/02/2012
Date last updated
11/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Does progesterone given as luteal phase support and amoxycillin as cervical mucus enhancer increase the likelihood of pregnancy in subfertile women receiving clomiphene citrate for anovulation?
Scientific title
In anovulatory women receiving clomiphene citrate does progesterone given as luteal phase support and amoxycillin given as a cervical mucus enhancer compared to placebo increase the likelihood of pregnancy?
Secondary ID [1] 279860 0
Nil
Universal Trial Number (UTN)
U1111-1120-8883
Trial acronym
Pregnancy Achieving Trial 3 (PATrial 3)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subfertility 285756 0
Anovulation 285757 0
Condition category
Condition code
Reproductive Health and Childbirth 285934 285934 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Periovulatory placebo (one orally three times daily) days 11-16 AND progesterone pessaries (400 mg vaginally at night) during each luteal phase (used for 10 consecutive nights) for up to 8 cycles
OR
Arm 2: Periovulatory amoxycillin (500mg orally three times daily) days 11-16 AND progesterone pessaries (400 mg vaginally at night) during each luteal phase (used for 10 consecutive nights) for up to 8 cycles

All participants will be instructed in the Sympto-Thermal Method.
All participants will be administered Clomiphene citrate orally (+/- metformin orally) at a dose necessary to induce ovulation
Intervention code [1] 284182 0
Treatment: Drugs
Comparator / control treatment
Periovulatory placebo (one orally three times daily) days 11-16 AND placebo vaginal pessaries during each luteal phase (used for 10 consecutive nights) for up to 8 cycles

All participants will be instructed in the Sympto-Thermal Method.
All participants will be administered Clomiphene citrate orally (+/- metformin orally) at a dose necessary to induce ovulation
Control group
Placebo

Outcomes
Primary outcome [1] 286426 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] 286426 0
Pregnancy test is to be performed in the clinical setting of a missed period on any cycle within the trial period for up to 8 months. (usually defined as 16 days after peak mucus sign or 15 days of sustained temperature shift in this population charting their menstrual cycle).
Secondary outcome [1] 295843 0
Time to conception
Timepoint [1] 295843 0
Diagnosis of pregnancy for up to 8 months
Secondary outcome [2] 295844 0
DASS 21 Scores - screening for depression, anxiety and stress
Timepoint [2] 295844 0
Diagnosis of pregnancy for up to 8 months OR at the completion of trial at 8 months if not pregnant
Secondary outcome [3] 295845 0
Acceptability of intervention - by completion of an acceptability survey tool
Timepoint [3] 295845 0
Diagnosis of pregnancy for up to 8 months OR at the completion of trial at 8 months if not pregnant
Secondary outcome [4] 295846 0
Cost effectiveness - looking at time, resources, medications, clinical setting costs
Timepoint [4] 295846 0
Diagnosis of pregnancy for up to 8 months OR at the completion of trial at 8 months if not pregnant
Secondary outcome [5] 295847 0
Live birth rate
Timepoint [5] 295847 0
Completion of index pregnancy
Secondary outcome [6] 295848 0
Miscarriage rate
Timepoint [6] 295848 0
Completion of index pregnancy
Secondary outcome [7] 295849 0
Gestation and weight at birth
Timepoint [7] 295849 0
Completion of index pregnancy
Secondary outcome [8] 295850 0
Congenital anomalies
Timepoint [8] 295850 0
Completion of index pregnancy
Secondary outcome [9] 295851 0
Neonatal morbidity composite - nursery admission (for any reason and including intraventricular haemorrhage, necrotising enterocolitis, respiratory distress syndrome)
Timepoint [9] 295851 0
Up to 4 weeks post delivery
Secondary outcome [10] 295852 0
Maternal morbidity composite - to include antepartum haemorrhage, gestational hypertension, pre-eclampsia, gestational diabetes, venothrombo-embolism, postnatal depression
Timepoint [10] 295852 0
Conception to 4 weeks post delivery

Eligibility
Key inclusion criteria
1. Anovulation (based on prolonged and hormonally quiescent 'cycles') 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
7. Women who have a penicillin allergy

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.
Anovulatory subfertility determined, informed of trial, clomiphene (+/- metformin) given to achieve ovulation, meet criteria.
Consented, enrolled, participate in standardised anatomy, physiology and fertility awareness instruction.
Participate in standardised Sympto-Thermal Method instruction.
'Script' given, dispensed as blinded therapy at the pharmacy according to the 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
Three arm trial;
Periovulatory placebo, Luteal placebo
Periovulatory placebo, Luteal progesterone
Periovulatory amoxycillin, luteal progesterone
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284634 0
Hospital
Name [1] 284634 0
Mater Mothers' Hospital
Country [1] 284634 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] 283547 0
Hospital
Name [1] 283547 0
Mater Mothers' Hospital
Address [1] 283547 0
Raymond Terrace
South Brisbane
Queensland 4101
Country [1] 283547 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286627 0
Mater Health Services Human Research Ethics Committee
Ethics committee address [1] 286627 0
Mater Health Services
Raymond Terrace
South Brisbane
Queensland 4101
Ethics committee country [1] 286627 0
Australia
Date submitted for ethics approval [1] 286627 0
Approval date [1] 286627 0
15/12/2010
Ethics approval number [1] 286627 0
EC00332

Summary
Brief summary
This project aims to assess the effectiveness of progesterone (as luteal phase support) and amoxycillin (as a cervical mucus enhancer) for pregnancy achievement, in previously anovulatory women currently ovulating on clomiphene citrate (+/- metformin).

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

It is hypothesised that:
1. Progesterone given as luteal phase support increases the likelihood of pregnancy in subfertile women receiving clomiphene citrate for anovulation.
2. Amoxycillin (as cervical mucus enhancer) plus progesterone (as luteal phase support) increases the likelihood of pregnancy in subfertile women receiving clomiphene citrate for anovulation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33725 0
Address 33725 0
Country 33725 0
Phone 33725 0
Fax 33725 0
Email 33725 0
Contact person for public queries
Name 16972 0
Clinical Midwife
Address 16972 0
Fertility Assessment and Research Clinic
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
Queensland 4101
Country 16972 0
Australia
Phone 16972 0
61 7 3163 8437
Fax 16972 0
Email 16972 0
[email protected]
Contact person for scientific queries
Name 7900 0
Dr Luke McLindon
Address 7900 0
Mater Mothers' Hospital
Raymond Terrace
South Brisbane
Queensland 4101
Country 7900 0
Australia
Phone 7900 0
61 7 3163 8111
Fax 7900 0
Email 7900 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

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