Trial record 9 of 357 for:    nichd Infertility/Fertility OR Fertility/Infertility

Cervical Mucus - the Biochemical and Molecular Properties in Fertile and Subfertile Women (C-MIS Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Merrion Fertility Clinic
Sponsor:
Collaborator:
University College Dublin
Information provided by (Responsible Party):
Merrion Fertility Clinic
ClinicalTrials.gov Identifier:
NCT01678859
First received: August 31, 2012
Last updated: September 5, 2013
Last verified: September 2013
  Purpose

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
Infertility

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cervical Mucus - the Biochemical and Molecular Properties in Fertile and Subfertile Women

Resource links provided by NLM:


Further study details as provided by Merrion Fertility Clinic:

Primary Outcome Measures:
  • The ability of sperm to swim through cervical mucus [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

cervical mucus serum


Estimated Enrollment: 90
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
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:

  1. To determine the functional, biochemical and molecular properties of cervical mucus through out the menstrual cycle in fertile women.
  2. To determine if there is a difference in these properties of cervical mucus in fertile and sub-fertile women.
  3. To determine whether these properties are influenced by the sub-fertility diagnostic group eg unexplained, endometriosis, tubal factor, sperm factor.
  4. To examine the interaction between cervical mucus and sperm in women with normal fertility and sub-fertility.
  5. To examine the impact of cervical surgery on cervical mucus functional, biochemical and molecular properties and sperm interaction.
  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

gyanecological outpatient department

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678859

Contacts
Contact: fiona m martyn, MB, MRCOG 00353-1-6635000 ext 4058 f_martyn@yahoo.com
Contact: mary wingfield, MD, FRCOG 00353-1-6635000 ext 4003 mbwingfield@gmail.com

Locations
Ireland
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    f_martyn@yahoo.com   
Sub-Investigator: fiona m martyn, MB,MRCOG         
Sponsors and Collaborators
Merrion Fertility Clinic
University College Dublin
Investigators
Principal Investigator: mary wingfield, MD, FRCOG merrion fertility clinic/National Maternity Hospital
  More Information

No publications provided

Responsible Party: Merrion Fertility Clinic
ClinicalTrials.gov Identifier: NCT01678859     History of Changes
Other Study ID Numbers: MFC 1
Study First Received: August 31, 2012
Last Updated: September 5, 2013
Health Authority: Ireland:Ethics committee, NMH

Keywords provided by Merrion Fertility Clinic:
infertility
cervical
mucus
sperm
interaction

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 23, 2014