Cervical Mucus - the Biochemical and Molecular Properties in Fertile and Subfertile Women (C-MIS Study) (C-MIS)
|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 evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01678859|
Recruitment Status : Unknown
Verified September 2013 by Merrion Fertility Clinic.
Recruitment status was: Recruiting
First Posted : September 5, 2012
Last Update Posted : September 6, 2013
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.
|Condition or disease|
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.
- 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 :||Observational|
|Estimated Enrollment :||90 participants|
|Observational Model:||Case Control|
|Official Title:||Cervical Mucus - the Biochemical and Molecular Properties in Fertile and Subfertile Women|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||August 2014|
- The ability of sperm to swim through cervical mucus [ Time Frame: 2 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678859
|Contact: fiona m martyn, MB, MRCOG||00353-1-6635000 ext firstname.lastname@example.org|
|Contact: mary wingfield, MD, FRCOG||00353-1-6635000 ext email@example.com|
|Merrion fertility clinic/national maternity hospital||Recruiting|
|Holles streetdublin 2, ireland, Dublin 2, Ireland|
|Contact: fiona m martyn, MB,MRCOG 00353-1-6635000 ext 4058 firstname.lastname@example.org|
|Sub-Investigator: fiona m martyn, MB,MRCOG|
|Principal Investigator:||mary wingfield, MD, FRCOG||merrion fertility clinic/National Maternity Hospital|