Infertility Clinical Trial
— C-MISOfficial 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.
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility |
Inclusion Criteria: 1. Fertile women 1. Age 18-42 years 2. Regular ovulatory menstrual cycle 3. Previous spontaneous pregnancy to term 4. No history of subfertility 5. No underlying medical condition or immunosuppression 6. No history of hormonal medication or pregnancy in past two months 7. Capable of giving informed consent to participate in study 2. 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: 1. hormonal medication 2. pregnancy 3. not capable of giving consent 4. age <18 years or > 42 years 5. underlying medical condition |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Ireland | Merrion fertility clinic/national maternity hospital | Holles streetdublin 2, ireland | Dublin 2 |
Lead Sponsor | Collaborator |
---|---|
Merrion Fertility Clinic | University College Dublin |
Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The ability of sperm to swim through cervical mucus | 2 years | No |
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