InfertilityC-MISNCT01678859
Cervical Mucus - the Biochemical and Molecular Properties in Fertile and Subfertile Women (C-MIS Study)
An observational study of Infertility, run by Merrion Fertility Clinic at 1 site in Ireland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 90 participants
- Where
- 1 siteIreland
- Study dates
- Aug 2012to Aug 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: gyanecological outpatient department
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- hormonal medication
- pregnancy
- not capable of giving consent
- age <18 years or > 42 years
- underlying medical condition
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Merrion fertility clinic/national maternity hospital
Holles Streetdublin 2, Ireland, Dublin 2
fiona m martyn, MB,MRCOG, 00353-1-6635000 ext. 4058, f_martyn@yahoo.com
fiona m martyn, MB,MRCOG
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Infertility
- Keywords
- infertility, cervical, mucus, sperm, interaction
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of sperm to swim through cervical mucus
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merrion Fertility Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University College Dublin
- Responsible party
- Sponsor
- Investigators
- mary wingfield, MD, FRCOG, Principal investigator, merrion fertility clinic/National Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678859
- Sponsor's protocol ID
- MFC 1
- Acronym
- C-MIS
- Status last verified
- Sep 2013
- First submitted
- 31 Aug 2012
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Mucus - the Biochemical and Molecular Properties in Fertile and Subfertile Women
- ClinicalTrials.gov ID
- NCT01678859
- Acronym / sponsor ID
- C-MIS / MFC 1
- Conditions
- Infertility
- Keywords
- infertility, cervical, mucus, sperm, interaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Merrion Fertility ClinicUniversity, hospital or other
- Collaborators
- University College Dublin
- Study start
- Aug 2012
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- gyanecological outpatient department
Key inclusion criteria (9 listed)
- Fertile women
- 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
Key exclusion criteria (5 listed)
- hormonal medication
- pregnancy
- not capable of giving consent
- age <18 years or > 42 years
- underlying medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The ability of sperm to swim through cervical mucus
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mary wingfield, MD, FRCOG principal investigator
merrion fertility clinic/National Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Merrion Fertility Clinic at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fiona m martyn, MB, MRCOG (00353-1-6635000 ext. 4058, f_martyn@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ability of sperm to swim through cervical mucus (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2013.