Unexplained Infertility Among Asthmatic and Atopic Patients

NCT01788735 | Unknown DMC

• 1 other identifier: AF
• Study Type: observational
• Target: 396
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopics; Unexplained Infertility

Keywords

unexplained infertility; asthma; allergy

Outcome Measures

Primary Outcomes (1)

• Time to pregnancy

  12 month

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• unexplained infertile

You may not qualify if:

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

Sponsors & Collaborators

• Elisabeth Juul Gade: lead
• Danish Medical Association: collaborator

Study Sites (1)

Respiratory Research Unit, Bispebjer Hospital

Copenhagen, 2400, Denmark

RECRUITING

Related Publications (1)

• Gade EJ, Thomsen SF, Lindenberg S, Backer V. Fertility outcomes in asthma: a clinical study of 245 women with unexplained infertility. Eur Respir J. 2016 Apr;47(4):1144-51. doi: 10.1183/13993003.01389-2015. Epub 2016 Feb 11.

  PMID: 26869675 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blod, serum

MeSH Terms

Conditions

Asthma; Hypersensitivity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Vibeke Backer, Professor

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 11, 2013
• Study Start: December 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: October 1, 2014
• Last Updated: February 11, 2013

Record last verified: 2013-02

Locations

DK (1)