Unexplained Infertility Among Asthmatic and Atopic Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Bispebjerg Hospital
Sponsor:
Collaborator:
Danish medical association
Information provided by (Responsible Party):
Elisabeth Juul Gade, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01788735
First received: February 8, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

Unexplained infertility is defined as the lack of thec ability to become pregnant during the first year, although the periods of the woman, the semen from the man and the laparoscopic findings are normal. In Denmark do roughly every fifth to seven couple in the fertile age have problems becoming pregnant for a various kind of reasons, of these are 10-15 % unexplained infertile.

Many factors are pointed out as imported. In particularly lifestyle factors such as the diet, smocking, obesity, lack of physic activity and alcohol. The causal connection is yet to be found, but it is assumed that there is a link between infertility and endocrine, neurological and immunological factors.

Asthma and allergy are some of the most common diseases among young people in western world .The development of these diseases are caused by both hereditary factors, and factors that also seem to be important in infertility.

It is clinically observed that many unexplained infertile patients simultaneously suffer from asthma and allergy. Furthermore this group of patients seems harder to treat in terms of becoming pregnant during fertility treatment then healthy not asthmatic and non allergic persons.

There is limited available data about this subject and the data that is already collected does not show a clear tendency.

Hypothesis: Atopic asthma is characterized by a systemic inflammation and can therefore be the reason for infertility among this group of patients.

The aim:

The aim of this study is to examine whether female asthmatics and allergic are less fertile then healthy females- whether there is there a link between asthma and infertility. Furthermore if an optimal asthma treatment during fertility treatment reduces time to pregnancy.


Condition
Atopics
Unexplained Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Unexplained Infertility Among Asthmatic and Atopic Patients

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Time to pregnancy [ Time Frame: 12 month ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

whole blod, serum


Estimated Enrollment: 396
Study Start Date: December 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

young healthy wemon that are unexplained infetile and have asthma, atopic ezcema or allergy

Criteria

Inclusion Criteria:

  • unexplained infertile

Exclusion Criteria:

  • no other diseases of the lung then asthma
  • non- smoking
  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: NCT01788735

Locations
Denmark
Respiratory Research Unit, Bispebjer Hospital Recruiting
Copenhagen, Denmark, 2400
Contact: Elisabeth Juul Gade, M.D    +4526149695    elisabeth_gade@yahoo.com   
Sponsors and Collaborators
Elisabeth Juul Gade
Danish medical association
Investigators
Principal Investigator: Vibeke Backer, Professor Bispebjerg Hospital
  More Information

No publications provided

Responsible Party: Elisabeth Juul Gade, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01788735     History of Changes
Other Study ID Numbers: AF
Study First Received: February 8, 2013
Last Updated: February 8, 2013
Health Authority: Denmark: The Ministry of the Interior and Health

Keywords provided by Bispebjerg Hospital:
unexplained infertility
asthma
allergy

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

ClinicalTrials.gov processed this record on July 23, 2014