AtopicsNCT01788735
Unexplained Infertility Among Asthmatic and Atopic Patients
An observational study of Atopics and Unexplained Infertility, run by Elisabeth Juul Gade at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Atopics, Unexplained Infertility
- How many people
- 396 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2011to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: young healthy wemon that are unexplained infetile and have asthma, atopic ezcema or allergy
Who may be able to join
- unexplained infertile
Who cannot join
- no other diseases of the lung then asthma
- non- smoking
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Respiratory Research Unit, Bispebjer Hospital
Copenhagen, 2400
Elisabeth Juul Gade, M.D, +4526149695, elisabeth_gade@yahoo.com
About this study
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.
Read more
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.
Read the detailed description
Introduction:
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.
The design:
The project is divided into 3 parts:
- A Study of Population. In the first part of this project the aim is to evaluate the occurrence of asthmatic and allergic diseases among women with respectively normal fertility and infertility. This is done through data already collected in The Danish twin Study from 1998- 2002 concerning questions about asthma, hay fever, atopic eczema and number of children.
- A Prospective Study In the second part of this project the aim is to examine clinically, whether female asthmatics in general have more difficulties becoming pregnant then non- asthmatic females. Furthermore we aim to evaluate whether it is allergic or non allergic asthma that affects the fertility the most.
- Casual study In the third part of this project we only include 40 of the unexplained infertile females collected earlier- 10 females with asthma, 10 females with allergy, 10 females with both asthma and allergy, 10 without any atopic disease.These women have, in addition to the initial asthma and allergy diagnosis, made a suction of the mucus in the uterus, when they are ovulating. This in order to determine whether the environment in the uterus is different in terms of inflammation in atopics. The aim of this study is to find an explanation for a possible decreased pregnancy rate and a longer time to pregnancy in atopics.
Material :
396 unexplained infertile females are included, when starting treatment at a fertility clinic. Among these are 197 healthy unexplained infertile females and 197 are females with the combination asthma and unexplained infertility. They are all included due to specific inclusion and exclusion criteria.
Methods:
All subjects are by inclusion tested for asthma with bronchial provocation tests. The pulmonary function is measured and the severity of their possible asthma is examined by NO in the expired air. Blood samples (RAS test) and prick test are performed to evaluate their possible allergy status. All subjects are to fill out questionnaires concerning asthma, allergy and their infertility. Due to the test mentioned above the subjects are divided in to groups, asthmatic , allergics, atopics and non- atopics.
The female asthmatics are treated due to the international guidelines. All groups are followed till achieved pregnancy; where after time to pregnancy can be compared.¨
In the third part of the study a suction of the mucus in the uterus is made at time of ovulation, to determinate the level of inflammation in atopics versus non atopics at time of fertilization.The mucus is examined fore inflammatory markers related to atopy such as TNF alpha, IL4,5,6,8and 33.
- Conditions
- Atopics, Unexplained Infertility
- Keywords
- unexplained infertility, asthma, allergy
- Medical subject headings
- Asthma, Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to pregnancy
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startDec 2011
- Primary completionDec 2013 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtopicsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elisabeth Juul Gade
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Medical Association
- Responsible party
- Sponsor-investigator, Elisabeth Juul Gade, Bispebjerg Hospital
- Investigators
- Vibeke Backer, Professor, Principal investigator, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788735
- Sponsor's protocol ID
- AF
- Status last verified
- Feb 2013
- First submitted
- 8 Feb 2013
- Last updated
- 11 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26869675
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unexplained Infertility Among Asthmatic and Atopic Patients
- ClinicalTrials.gov ID
- NCT01788735
- Acronym / sponsor ID
- AF
- Conditions
- Atopics, Unexplained Infertility
- Keywords
- unexplained infertility, asthma, allergy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- Elisabeth Juul GadeUniversity, hospital or other
- Collaborators
- Danish Medical Association
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction:
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.
The design:
The project is divided into 3 parts:
- A Study of Population. In the first part of this project the aim is to evaluate the occurrence of asthmatic and allergic diseases among women with respectively normal fertility and infertility. This is done through data already collected in The Danish twin Study from 1998- 2002 concerning questions about asthma, hay fever, atopic eczema and number of children.
- A Prospective Study In the second part of this project the aim is to examine clinically, whether female asthmatics in general have more difficulties becoming pregnant then non- asthmatic females. Furthermore we aim to evaluate whether it is allergic or non allergic asthma that affects the fertility the most.
- Casual study In the third part of this project we only include 40 of the unexplained infertile females collected earlier- 10 females with asthma, 10 females with allergy, 10 females with both asthma and allergy, 10 without any atopic disease.These women have, in addition to the initial asthma and allergy diagnosis, made a suction of the mucus in the uterus, when they are ovulating. This in order to determine whether the environment in the uterus is different in terms of inflammation in atopics. The aim of this study is to find an explanation for a possible decreased pregnancy rate and a longer time to pregnancy in atopics.
Material :
396 unexplained infertile females are included, when starting treatment at a fertility clinic. Among these are 197 healthy unexplained infertile females and 197 are females with the combination asthma and unexplained infertility. They are all included due to specific inclusion and exclusion criteria.
Methods:
All subjects are by inclusion tested for asthma with bronchial provocation tests. The pulmonary function is measured and the severity of their possible asthma is examined by NO in the expired air. Blood samples (RAS test) and prick test are performed to evaluate their possible allergy status. All subjects are to fill out questionnaires concerning asthma, allergy and their infertility. Due to the test mentioned above the subjects are divided in to groups, asthmatic , allergics, atopics and non- atopics.
The female asthmatics are treated due to the international guidelines. All groups are followed till achieved pregnancy; where after time to pregnancy can be compared.¨
In the third part of the study a suction of the mucus in the uterus is made at time of ovulation, to determinate the level of inflammation in atopics versus non atopics at time of fertilization.The mucus is examined fore inflammatory markers related to atopy such as TNF alpha, IL4,5,6,8and 33.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- young healthy wemon that are unexplained infetile and have asthma, atopic ezcema or allergy
Key inclusion criteria (1 listed)
- unexplained infertile
Key exclusion criteria (2 listed)
- no other diseases of the lung then asthma
- non- smoking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to pregnancy
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2013.
- Derived from this study: PubMed 26869675Gade 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vibeke Backer, Professor principal investigator
Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopics and Unexplained Infertility, run by Elisabeth Juul Gade at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to pregnancy (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01788735, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2013.