Burden, InfertilityNCT06664086
Economic and Psychological Burden of Infertility Among Women Attending Women Health Hospital, Assiut University
An observational study of Burden, Infertility, run by Assiut University.
Trial summary
Rational of the study: Infertility is a significant reproductive health issue for couples worldwide. The effects of infertility are wide-ranging-from mental health issues such as anxiety and depression to social and economic issues such as ostracization and economic problems. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women only
- Conditions the study is for
- Burden, Infertility
- What is being tested?
- economic and psychological burden
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to Jun 2026
- 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 15 to 49 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Data will be collected through a semi-structured interviewer administered questionnaire. From IVF unit and outpatient gynecological clinic at women health hospital, Assiut university .
Who may be able to join
- • reproductive age group 15 - 49
- Duration of marriage not less than 1 year.
- Has regular sexual intercourse without the functional use of contraceptive methods.
- Free from any other debilitating chronic illness.
Who cannot join
- Women who have any previous psychological disease or treatment
Trial locations and contacts
No sites are listed yet.
About this study
Rational of the study:
Infertility is a significant reproductive health issue for couples worldwide. The effects of infertility are wide-ranging-from mental health issues such as anxiety and depression to social and economic issues such as ostracization and economic problems. Although infertility affects both men and women, the woman in a couple is most often blamed for the inability to bear children.
Read the detailed description
Infertility is a disease of the male or female reproductive system, defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse (WHO).
Large numbers of people are affected by infertility in their lifetime, according to a new report published by World Health Organization. Around 17.5% of the adult population - roughly 1 in 6 worldwide - experience infertility. The inability to conceive children is experienced as a stressful situation by individuals and couples all around the world. The consequences of infertility are manifold and may include societal repercussions and personal emotional suffering. The infertile couple experienced greater dissatisfaction with themselves and their marriages. Females experienced greater discontent over time and had greater emotional problems than males because infertility had traditionally been viewed as a women problem and women have been expected to suffer greater emotional problems due to infertility. Treatment for infertility provides an opportunity for women and men to become parents. The evolution of assisted reproductive technology (ART) for the treatment of infertile couples is considered an extraordinary restorative accomplishment throughout the world. However accessibility of treatments such as IVF is limited to only those who can afford to pay out of pocket (OOP). Even among those who have the ability to pay, their willingness and financial ability to undergo multiple cycles of ART often depends on OOP payments incurred. However, due to the desire for a child, couples are often ready to make significant financial sacrifices often beyond their means. Couples are frequently willing to suffer catastrophic financial hardship instead of forgoing infertility care, resulting in negative economic consequences. Evidence suggests that in the absence of mechanisms for risk protection, OOP payments can push households into poverty.
- Conditions
- Burden, Infertility
- Being tested
- economic and psychological burden
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
economic and psychological burdenBehavioural
measuring the economic and psychological burden of infertility
| Study group | Role | What they receive |
|---|---|---|
| infertile women | women suffering from infertility Receives: Behavioral: economic and psychological burden | |
| fertile women | women having children not suffering from infertility. Receives: Behavioral: economic and psychological burden |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of psychological disorders as: anxiety, depression and stress among infertile women.
measuring prevalence of psychological disorders as: anxiety, depression and stress among infertile women using DASS scale
Measured: baseline
Financial and economic suffering of infertile couples
Financial and economic suffering of infertile couples
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Burden, InfertilityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Abdelmalek Abdallah, Assiut University
- Investigators
- Omaima ELGibaly, Professor, Study director, Professor at Public Health and Community Medicine Faculty of Medicine- Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664086
- Sponsor's protocol ID
- burden of infertility on women
- Status last verified
- Oct 2024
- First submitted
- 27 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Poddar S, Sanyal N, Mukherjee U. Psychological profile of women with infertility: A comparative study. Ind Psychiatry J. 2014 Jul-Dec;23(2):117-26. doi: 10.4103/0972-6748.151682.
PubMed 25788801Dyer SJ, Sherwood K, McIntyre D, Ataguba JE. Catastrophic payment for assisted reproduction techniques with conventional ovarian stimulation in the public health sector of South Africa: frequency and coping strategies. Hum Reprod. 2013 Oct;28(10):2755-64. doi: 10.1093/humrep/det290. Epub 2013 Jul 21.
PubMed 23878180
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic and Psychological Burden of Infertility Among Women Attending Women Health Hospital, Assiut University
- ClinicalTrials.gov ID
- NCT06664086
- Acronym / sponsor ID
- burden of infertility on women
- Conditions
- Burden, Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Oct 2024 (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.
Rational of the study:
Infertility is a significant reproductive health issue for couples worldwide. The effects of infertility are wide-ranging-from mental health issues such as anxiety and depression to social and economic issues such as ostracization and economic problems. Although infertility affects both men and women, the woman in a couple is most often blamed for the inability to bear children.
Detailed description
Infertility is a disease of the male or female reproductive system, defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse (WHO).
Large numbers of people are affected by infertility in their lifetime, according to a new report published by World Health Organization. Around 17.5% of the adult population - roughly 1 in 6 worldwide - experience infertility. The inability to conceive children is experienced as a stressful situation by individuals and couples all around the world. The consequences of infertility are manifold and may include societal repercussions and personal emotional suffering. The infertile couple experienced greater dissatisfaction with themselves and their marriages. Females experienced greater discontent over time and had greater emotional problems than males because infertility had traditionally been viewed as a women problem and women have been expected to suffer greater emotional problems due to infertility. Treatment for infertility provides an opportunity for women and men to become parents. The evolution of assisted reproductive technology (ART) for the treatment of infertile couples is considered an extraordinary restorative accomplishment throughout the world. However accessibility of treatments such as IVF is limited to only those who can afford to pay out of pocket (OOP). Even among those who have the ability to pay, their willingness and financial ability to undergo multiple cycles of ART often depends on OOP payments incurred. However, due to the desire for a child, couples are often ready to make significant financial sacrifices often beyond their means. Couples are frequently willing to suffer catastrophic financial hardship instead of forgoing infertility care, resulting in negative economic consequences. Evidence suggests that in the absence of mechanisms for risk protection, OOP payments can push households into poverty.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| infertile women | – | Behavioral: economic and psychological burdenwomen suffering from infertility |
| fertile women | – | Behavioral: economic and psychological burdenwomen having children not suffering from infertility. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Data will be collected through a semi-structured interviewer administered questionnaire. From IVF unit and outpatient gynecological clinic at women health hospital, Assiut university .
Key inclusion criteria (4 listed)
- • reproductive age group 15 - 49
Key exclusion criteria (1 listed)
- Women who have any previous psychological disease or treatment
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 |
|---|---|---|
| economic and psychological burdenmeasuring the economic and psychological burden of infertility | Behavioural | fertile women, infertile women |
Primary outcome
Prevalence of psychological disorders as: anxiety, depression and stress among infertile women.
Time frame: baseline
measuring prevalence of psychological disorders as: anxiety, depression and stress among infertile women using DASS scale
Financial and economic suffering of infertile couples
Time frame: baseline
Financial and economic suffering of infertile couples
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 25788801Poddar S, Sanyal N, Mukherjee U. Psychological profile of women with infertility: A comparative study. Ind Psychiatry J. 2014 Jul-Dec;23(2):117-26. doi: 10.4103/0972-6748.151682.
- Background: PubMed 23878180Dyer SJ, Sherwood K, McIntyre D, Ataguba JE. Catastrophic payment for assisted reproduction techniques with conventional ovarian stimulation in the public health sector of South Africa: frequency and coping strategies. Hum Reprod. 2013 Oct;28(10):2755-64. doi: 10.1093/humrep/det290. Epub 2013 Jul 21.
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.
Omaima ELGibaly, Professor study director
Professor at Public Health and Community Medicine Faculty of Medicine- Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Burden, Infertility, run by Assiut University.
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 4 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 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Marwa Orabi, Assistant lecturer (01063495239, Marwa.ma72@aun.med.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of psychological disorders as: anxiety, depression and stress among infertile women. (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT06664086, which also lists 2 linked publications.
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 29 Oct 2024.