Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000040066
Ethics application status
Approved
Date submitted
10/12/2009
Date registered
14/01/2010
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Seminal fluid and reproductive health in women
Scientific title
Seminal fluid as a determinant of reproductive health in healthy women: a study to investigate the effects of seminal fluid on cytokine gene expression and protein synthesis in cervical and endometrial tissue
Secondary ID [1] 1207 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
the effect of seminal fluid on female endometrial tissue 252377 0
Condition category
Condition code
Reproductive Health and Childbirth 256556 256556 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be involved in this study for 2 menstrual cycles only,comprising a control cycle and an intervention cycle. Arm 1 of this study is the intervention cycle during which participants will be randomised to have either (group a) intercourse at least once using condoms, (group b)intercourse at least once without condoms, or (group c) abstain from sexual intercourse. Intercourse will be timed to occur (group a and b) or not (group c) at time of Lutenising Hormone (LH) surge in menstrual cycle and endometrial biopsy will collected 10 - 12 hours after intercourse. During the cycle up to the time of randomisation and group allocation they will be required to abstain from intercourse or use a condom, to prevent contamination of the endometrium with seminal fluid. Arm 2 of the study is the control cycle during which an endometrial biopsy will be collected at time of LH surge, with out seminal fluid present. To aviod contamination of the endometrium with seminal fluid participants will be be able to chose to abstain from sexual intercourse or wear condoms for the duration of the cycle. There is no requirement for a washout period between cycles but there can be no longer than 3 months between intervention and control cycle. Total duration of participation in the study is 8 weeks (2 x 4week cycles)
Intervention code [1] 255678 0
Other interventions
Intervention code [2] 255712 0
Lifestyle
Comparator / control treatment
All participants will have a control cycle in which they will abstain from intercourse or use a condom prior to having an endometrial biopsy collected at time of LH (Lutenising Hormone) surge
Control group
Active

Outcomes
Primary outcome [1] 257445 0
determine a similar but distinct inflammatory cytokine response in cervical cells and endometrium after sexual intercourse for histochemical analysis. A sample will also be placed into RNAlater for extraction of ribonucleic acid (RNA) for quantative reverse transcription (qRT) polymerase chain reaction (PCR) and Affymetrix microarray analysis.
Timepoint [1] 257445 0
10 - 12 hours following intercourse at the time of the LH surge during a menstrual cycle
Secondary outcome [1] 262582 0
A blood sample will be collected at the time of endometrial biopsy to determine any effect of seminal fluid on number and phenotype of circulating T lymphocyte populations.
Timepoint [1] 262582 0
10 - 12 hours following intercourse at the time of the LH surge during a menstrual cycle

Eligibility
Key inclusion criteria
healthy volunteer women
having regular menstrual cycles (26-32 days)
have undergone or planning to have a tubal ligation
have a partner with proven fertility, (paternity in another relationship is allowed)
be currently sexually active
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
women using steroidal contraceptives, an intrauterine device contraception during the preceding two months. Barrier contraception is allowed.
women with active symptoms of infection
women whose partners are vasectomised or azoospermic

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All subjects will be enrolled for the intervention and control cycle.
There will be no allocation concealment procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomisation schedule will be used to allow allocation of intervention sexual intercourse with or without condoms or abstain during the intrevention cycle.
Subjects will have the intervention cycle first followed by the control cycle.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256164 0
Government body
Name [1] 256164 0
National Health and Medical research Council
Country [1] 256164 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Medical School North
Frome Road
Adelaide 5000
South Australia
Country
Australia
Secondary sponsor category [1] 251508 0
None
Name [1] 251508 0
Address [1] 251508 0
Country [1] 251508 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258269 0
Children's Youth and Women's Health Service (CYWHS) Research Ethics Committee
Ethics committee address [1] 258269 0
Ethics committee country [1] 258269 0
Australia
Date submitted for ethics approval [1] 258269 0
Approval date [1] 258269 0
23/11/2009
Ethics approval number [1] 258269 0
12/07/2191

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30604 0
Address 30604 0
Country 30604 0
Phone 30604 0
Fax 30604 0
Email 30604 0
Contact person for public queries
Name 13851 0
Helen Alvino
Address 13851 0
Medical School North
Frome Road
Adelaide 5000
SA
Country 13851 0
Australia
Phone 13851 0
+61 419843418
Fax 13851 0
+61 8 8303 4099
Email 13851 0
[email protected]
Contact person for scientific queries
Name 4779 0
Professor Sarah Robertson
Address 4779 0
Medical School North
Frome Road
Adelaide 5000
SA
Country 4779 0
Australia
Phone 4779 0
+61 8 8303 4094
Fax 4779 0
+61 8 8303 4099
Email 4779 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.