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Unexplained Infertility Among Asthmatic and Atopic Patients

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ClinicalTrials.gov Identifier: NCT01788735
Recruitment Status : Unknown
Verified February 2013 by Elisabeth Juul Gade, Bispebjerg Hospital.
Recruitment status was:  Recruiting
First Posted : February 11, 2013
Last Update Posted : February 11, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Atopics Unexplained Infertility

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 396 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Unexplained Infertility Among Asthmatic and Atopic Patients
Study Start Date : December 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Infertility
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Time to pregnancy [ Time Frame: 12 month ]

Biospecimen Retention:   Samples Without DNA
whole blod, serum

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

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): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elisabeth Juul Gade, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01788735     History of Changes
Other Study ID Numbers: AF
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: February 2013

Keywords provided by Elisabeth Juul Gade, Bispebjerg Hospital:
unexplained infertility
asthma
allergy

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