Cervical Surgery and the Fertility Effect (c-SAFE)

NCT01944241 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2013-09-17

No results posted yet for this study

Summary

Over the last 20 years, cervical screening programs have had huge success in reducing cervical cancer rates. These programs have done this by screening women at risk of developing cancer with regular smear tests. Women with abnormal smears are followed up in colposcopy clinics, and where needed, cervical surgery is performed to remove pre-cancerous areas on the cervix.

Surgery to the cervix can include LLETZ (Large loop excision of the transformation zone) treatment or cone biopsy. Many studies in the last few years have looked at the impact that this necessary surgery can have on the function of the cervix. These studies have mainly found an association between LLETZ treatment and an increased risk of preterm labour. There have been no large studies investigating the effect cervical surgery may have on fertility.

The investigators would like to examine the impact that cervical surgery may have on a woman's future fertility. It has been postulated that cervical surgery may cause the cervix to close, preventing sperm getting through or that it may cause changes in the secretions of the cervix, secretions that are necessary for normal interaction with sperm.

The investigators would like to send a questionnaire to women who have attended colposcopy. The investigators will ask these women a series of questions relating to fertility desires and divide the women in to two groups depending on whether the women needed cervical surgery for pre-cancerous lesions or not.

Hypothesis: That cervical surgery has an impact on the function of the cervix and on fertility.

Conditions

Sponsors & Collaborators

  • University College Dublin

    collaborator OTHER
  • Merrion Fertility Clinic

    lead OTHER

Principal Investigators

  • mary wingfield, MRCOG,MD · Merrion Fertility Clinic, National Maternity Hospital

Eligibility

Min Age
25 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Ireland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01944241 on ClinicalTrials.gov