Impact of Reproductive Problems on Couples

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03365830
Recruitment Status : Not yet recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Information provided by (Responsible Party):
Murat Dogan, Acibadem University

Brief 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. 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.

Condition or disease Intervention/treatment
Infertility Diagnostic Test: FertQol, Beck's Depression Inventory, Beck's Anxiety Inventory

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 Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Impact of Reproductive Problems on Physical, Emotional, Social Life Areas in Couples Receiving Infertility Treatment
Estimated Study Start Date : December 15, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : January 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Infertility

Intervention Details:
  • Diagnostic Test: FertQol, Beck's Depression Inventory, Beck's Anxiety Inventory
    These 3 scale will be given to patients to fill up who takes infertility treatments

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Couples who takes IVF treatment

Inclusion Criteria:

  1. Diagnosis of infertility,
  2. IVF therapy
  3. At least elementary school graduate,
  4. Married,
  5. Communication is not obstacle,
  6. Couples who agree to participate in the work

Exclusion Criteria:

  • Other than inclusion criteria

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 identifier (NCT number): NCT03365830

Contact: Murat Dogan 00905056139577
Contact: Ercan BAstu 00905059582999

Acibadem Fulya Hospital
Istanbul, Besiktas, Turkey, 34349
Sponsors and Collaborators
Acibadem University

Additional Information:
Publications of Results:
Responsible Party: Murat Dogan, primer investigator, Acibadem University Identifier: NCT03365830     History of Changes
Other Study ID Numbers: Ob&Gyn Fulya2
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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