InfertilityNCT03365830
Impact of Reproductive Problems on Couples
An observational study of Infertility, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
Reproduction is in fact the most basic instinct of all living things. The fertility of a woman is both a biological fact and a determinant of gender role in society. Motherhood is still seen as the primary role for women in society. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- FertQol, Beck's Depression Inventory, Beck's Anxiety Inventory
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2017to 30 Jan 2019
- How long will I take part?
- 12 Months
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Couples who takes IVF treatment
Who may be able to join
- Diagnosis of infertility,
- IVF therapy
- At least elementary school graduate,
- Married,
- Communication is not obstacle,
- Couples who agree to participate in the work
Who cannot join
- Other than inclusion criteria
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem Fulya Hospital
Istanbul, Besiktas, 34349
About this study
Official title: Impact of Reproductive Problems on Physical, Emotional, Social Life Areas in Couples Receiving Infertility Treatment
Reproduction is in fact the most basic instinct of all living things. The fertility of a woman is both a biological fact and a determinant of gender role in society. Motherhood is still seen as the primary role for women in society. Infertility, which manifests itself as a sudden and unexpected life crisis, is an unexpected, perhaps unexplained, condition that spreads over a long period of time, creates extreme stress and forces adjustment mechanisms. Infertility can affect the quality of life by adversely affecting the physical, emotional, social and relational living spaces of people.
The present study examines the effects of reproductive problems on the quality of life in women who receive infertility treatment, and in the direction of the results obtained, the treatment recipients of the health workers are planned to help develop a holistic perspective that takes into account not only reproductive problems but also other affected living areas.
Read the detailed description
Infertility is a psychological threat, emotional stress, economically expensive, painful and complex life crisis for the treatment for couples. Infertility has negative effects on social and psychological well-being rather than physical health. Infertile people accept this situation as a serious apology, and as a result of their emotional feeling, they are isolated from their surroundings over time. Therefore, infertility is not a simple gynecologic syndrome, and it is a condition that especially affects the woman very biologically, psychologically and socially, resulting in a decrease in health and quality of life. While infertility is not a life threatening health problem, the couple threatens healthy life with negative effects on mental health and quality of life and is defined as a life crisis by some authors. Studies in infertile couples have shown that women experience more anxiety, depression, stress and hostility in their lives than men, and that sexual life is negatively affected.
Today, unforeseen infertility, often unexplained and unpredictable, is considered to have created a stressful situation that pushes the coping mechanisms for a couple and destroys the sense of health and integrity.
The more a woman's identity is defined by her being a mother, the greater the amount of her psychological distress and disability. The longer the duration of infertility, the more dominance and hopelessness dominate and this can result in a greater depression. Generally, psychosocial effects of infertility also affect the components of quality of life in a negative way. The most affected areas are mental health, emotional behavior, environmental psychology, physical and social functions.
In many studies, it was determined that stress, anxiety and depression scores of infertile couples were higher than the fertile population. Anger, nervousness, decreased self-esteem, poor interpersonal relationships, reduced life satisfaction, anxiety and depression are frequently seen psychological disorders associated with infertility.
As a result, infertility is a stressful event for couples with children, and it is also a condition that affects the relationship of couples. The infertile couples have profoundly affected their marriages and social lives because of the long treatment duration, the destructive effect on the continuing mental health, the complexity of the treatment procedures, the unusual and long steps required and the consequences of the IVF treatment.
- Conditions
- Infertility
- Being tested
- FertQol, Beck's Depression Inventory, Beck's Anxiety Inventory
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FertQol, Beck's Depression Inventory, Beck's Anxiety InventoryDiagnostic test
These 3 scale will be given to patients to fill up who takes infertility treatments
What is being measured
The primary outcome is the main question the study is designed to answer.
Cronbach alpha value of emotions, general health, cognitive skills and performance of activities of daily living, partnership, and social and family relationships
The fertility quality of life (FertiQoL) measure specifically evaluates the impact of fertility problems in various life areas. The aim of this study was to examine the relationship between FertiQoL and Beck's Depression Inventory and Beck's Anxiety Inventory
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start15 Dec 2017 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion30 Jan 2019 (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 InfertilityStudies 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
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Dogan, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365830
- Sponsor's protocol ID
- Ob&Gyn Fulya2
- Status last verified
- Dec 2017
- First submitted
- 29 Nov 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dural O, Yasa C, Keyif B, Celiksoy H, Demiral I, Yuksel Ozgor B, Gungor Ugurlucan F, Bastu E. Effect of infertility on quality of life of women: a validation study of the Turkish FertiQoL. Hum Fertil (Camb). 2016 Sep;19(3):186-91. doi: 10.1080/14647273.2016.1214754. Epub 2016 Aug 2.
PubMed 27486018
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Reproductive Problems on Physical, Emotional, Social Life Areas in Couples Receiving Infertility Treatment
- ClinicalTrials.gov ID
- NCT03365830
- Acronym / sponsor ID
- Ob&Gyn Fulya2
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 15 Dec 2017 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 30 Jan 2019 (estimated)
- First posted
- 7 Dec 2017 (actual)
- 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.
Reproduction is in fact the most basic instinct of all living things. The fertility of a woman is both a biological fact and a determinant of gender role in society. Motherhood is still seen as the primary role for women in society. Infertility, which manifests itself as a sudden and unexpected life crisis, is an unexpected, perhaps unexplained, condition that spreads over a long period of time, creates extreme stress and forces adjustment mechanisms. Infertility can affect the quality of life by adversely affecting the physical, emotional, social and relational living spaces of people.
The present study examines the effects of reproductive problems on the quality of life in women who receive infertility treatment, and in the direction of the results obtained, the treatment recipients of the health workers are planned to help develop a holistic perspective that takes into account not only reproductive problems but also other affected living areas.
Detailed description
Infertility is a psychological threat, emotional stress, economically expensive, painful and complex life crisis for the treatment for couples. Infertility has negative effects on social and psychological well-being rather than physical health. Infertile people accept this situation as a serious apology, and as a result of their emotional feeling, they are isolated from their surroundings over time. Therefore, infertility is not a simple gynecologic syndrome, and it is a condition that especially affects the woman very biologically, psychologically and socially, resulting in a decrease in health and quality of life. While infertility is not a life threatening health problem, the couple threatens healthy life with negative effects on mental health and quality of life and is defined as a life crisis by some authors. Studies in infertile couples have shown that women experience more anxiety, depression, stress and hostility in their lives than men, and that sexual life is negatively affected.
Today, unforeseen infertility, often unexplained and unpredictable, is considered to have created a stressful situation that pushes the coping mechanisms for a couple and destroys the sense of health and integrity.
The more a woman's identity is defined by her being a mother, the greater the amount of her psychological distress and disability. The longer the duration of infertility, the more dominance and hopelessness dominate and this can result in a greater depression. Generally, psychosocial effects of infertility also affect the components of quality of life in a negative way. The most affected areas are mental health, emotional behavior, environmental psychology, physical and social functions.
In many studies, it was determined that stress, anxiety and depression scores of infertile couples were higher than the fertile population. Anger, nervousness, decreased self-esteem, poor interpersonal relationships, reduced life satisfaction, anxiety and depression are frequently seen psychological disorders associated with infertility.
As a result, infertility is a stressful event for couples with children, and it is also a condition that affects the relationship of couples. The infertile couples have profoundly affected their marriages and social lives because of the long treatment duration, the destructive effect on the continuing mental health, the complexity of the treatment procedures, the unusual and long steps required and the consequences of the IVF treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Couples who takes IVF treatment
Key inclusion criteria (6 listed)
- Diagnosis of infertility,
- IVF therapy
- At least elementary school graduate,
- Married,
- Communication is not obstacle,
Key exclusion criteria (1 listed)
- Other than inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FertQol, Beck's Depression Inventory, Beck's Anxiety InventoryThese 3 scale will be given to patients to fill up who takes infertility treatments | Diagnostic test | – |
Primary outcome
Cronbach alpha value of emotions, general health, cognitive skills and performance of activities of daily living, partnership, and social and family relationships
Time frame: 12 months
The fertility quality of life (FertiQoL) measure specifically evaluates the impact of fertility problems in various life areas. The aim of this study was to examine the relationship between FertiQoL and Beck's Depression Inventory and Beck's Anxiety Inventory
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Results publication: PubMed 27486018Dural O, Yasa C, Keyif B, Celiksoy H, Demiral I, Yuksel Ozgor B, Gungor Ugurlucan F, Bastu E. Effect of infertility on quality of life of women: a validation study of the Turkish FertiQoL. Hum Fertil (Camb). 2016 Sep;19(3):186-91. doi: 10.1080/14647273.2016.1214754. Epub 2016 Aug 2.
- FertiQolLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
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 Infertility, run by Acibadem University at 1 site in Turkey (Türkiye).
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 6 inclusion and 1 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 7 Dec 2017. 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 Turkey (Türkiye). 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?
Contact Murat Dogan (00905056139577, muratdogan1984@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cronbach alpha value of emotions, general health, cognitive skills and performance of activities of daily living, partnership, and social and family relationships (time frame: 12 months). 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 NCT03365830, 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 7 Dec 2017.