- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01678859
Cervical Mucus - the Biochemical and Molecular Properties in Fertile and Subfertile Women (C-MIS Study) (C-MIS)
Cervical Mucus - the Biochemical and Molecular Properties in Fertile and Subfertile Women
Infertility affects approximately one in six couples1. In approximately one third of cases, there is no cause found as to why a couple are unable to conceive2. In order for natural pregnancy to occur, sperm must pass through the cervix (neck of the womb) and swim to the woman's Fallopian tubes so that fertilisation of one of the woman's eggs can occur. It is known that mid-cycle mucus at the cervix is essential for sperm to gain access to the uterus and tubes.
There is evidence that the composition of this mucus in women may affect fertility but this area has not been studied well in recent years, partly because fertility treatments such as IVF bypass the cervix.
Research in sheep and cows in UCD has shown interesting differences in the cervical mucus of fertile and infertile animals. It appears that the mucus not only helps sperm to get to the uterus but may also help the sperm to mature and be ready to fertilise an egg. This mucus may also help prevent bacteria and infection reaching the womb.
In conjunction with colleagues in UCD, under the leadership of Professor S Carrington, the investigators would like to investigate some of the properties of human cervical mucus.The investigators propose to do this by taking samples of cervical mucus around the time of ovulation and also approximately one week later in fertile women and sub-fertile women. Then to monitor ovulation with an ultrasound scan (follicle tracking) of the woman's ovaries and urinary ovulation kits and take blood for oestrogen, progesterone, LH and FSH levels.
The investigators wish to determine if there are differences between the mucus of these women and how it may impact on sperm function and on fertility.
Study Overview
Status
Conditions
Detailed Description
This study will investigate functional, biochemical and molecular properties of cervical mucus at various times of the menstrual cycle in fertile and sub-fertile women. The investigators would aim to also investigate the interaction of cervical mucus with sperm and capacitation and to investigate the impact cervical surgery and differing diagnoses of sub-fertility have on cervical mucus.
Study aims:
- To determine the functional, biochemical and molecular properties of cervical mucus through out the menstrual cycle in fertile women.
- To determine if there is a difference in these properties of cervical mucus in fertile and sub-fertile women.
- To determine whether these properties are influenced by the sub-fertility diagnostic group eg unexplained, endometriosis, tubal factor, sperm factor.
- To examine the interaction between cervical mucus and sperm in women with normal fertility and sub-fertility.
- To examine the impact of cervical surgery on cervical mucus functional, biochemical and molecular properties and sperm interaction.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: fiona m martyn, MB, MRCOG
- Phone Number: 4058 00353-1-6635000
- Email: f_martyn@yahoo.com
Study Contact Backup
- Name: mary wingfield, MD, FRCOG
- Phone Number: 4003 00353-1-6635000
- Email: mbwingfield@gmail.com
Study Locations
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Dublin 2
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Holles streetdublin 2, ireland, Dublin 2, Ireland
- Recruiting
- Merrion fertility clinic/national maternity hospital
-
Contact:
- fiona m martyn, MB,MRCOG
- Phone Number: 4058 00353-1-6635000
- Email: f_martyn@yahoo.com
-
Sub-Investigator:
- fiona m martyn, MB,MRCOG
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Fertile women
- Age 18-42 years
- Regular ovulatory menstrual cycle
- Previous spontaneous pregnancy to term
- No history of subfertility
- No underlying medical condition or immunosuppression
- No history of hormonal medication or pregnancy in past two months
- Capable of giving informed consent to participate in study
- Non fertile women a.Age 18-42 years b.Regular ovulatory menstrual cycle c.Difficulty conceiving for greater than 12 months e.No underlying medical condition or immunosuppression f.No history of hormonal medication in past two months g.Capable of giving informed consent to participate in study
Exclusion Criteria:
- hormonal medication
- pregnancy
- not capable of giving consent
- age <18 years or > 42 years
- underlying medical condition
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The ability of sperm to swim through cervical mucus
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: mary wingfield, MD, FRCOG, Merrion fertility clinic/national maternity hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MFC 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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