InfertilityNCT02638441
Psychological Profile of Women With Infertility in Egypt: A Comparative Study
An observational study of Infertility, run by Ain Shams Maternity Hospital.
Trial summary
The aim of this study is to determine the prevalence of psychological affection in infertile egyptian women Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- hospital anxiety and depression scale
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jul 2016
- 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
- Women only
- Healthy volunteers accepted
- Adult
Study population: This study will be conducted at the department of Obstetrics and Gynecology of Ain shams university and Zagazig university and some private centres for the treatment of infertility. It will include 400 women, divided into two groups (control group and clinical group) starting from January 2016.
Who may be able to join
- Control group:
- Pregnant women.
- At least one live birth.
- Age group 20-40 years.
- Clinical group:
- Infertile women either primary or secondary according to (WHO,2013).
Show all 10Show fewer
- Age group 20-40ys.
- Different levels of education.
- Different methods of treatment of infertility (medical or IVF)
- Half of them from rural area the other half from urban area.
Who cannot join
- Male factor of infertility.
- The women with psychiatric disorders.
- The women with physical and medical disorders.
- The women whose current pregnancy has any problems (e.g. growth retardation, macrosomia, placenta previa, threatened abortion, or preterm labour).
- The women with history of intrauterine fetal death.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to determine the prevalence of psychological affection in infertile egyptian women
Read the detailed description
Comparative cross sectional study
- Conditions
- Infertility
- Being tested
- hospital anxiety and depression scale
- Keywords
- psychological health, women, anxiety, depression
- Medical subject headings
- Infertility, Psychological Well-Being, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hospital anxiety and depression scaleOther
Also called emotional distress of women with infertility
Detection of infertility effect on emotional status
What is being measured
The primary outcome is the main question the study is designed to answer.
determination of the prevalence of depression among infertile women
questionnaire will be used to collect qualititiative data from women
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Bahaa El Din, Ain Shams Maternity Hospital
- Investigators
- sherif a akl, Study director, professor of obstetric and gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638441
- Sponsor's protocol ID
- ADin
- Status last verified
- Dec 2015
- First submitted
- 15 Dec 2015
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Profile of Women With Infertility in Egypt: A Comparative Study
- ClinicalTrials.gov ID
- NCT02638441
- Acronym / sponsor ID
- ADin
- Conditions
- Infertility
- Keywords
- psychological health, women, anxiety, depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 23 Dec 2015 (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.
The aim of this study is to determine the prevalence of psychological affection in infertile egyptian women
Detailed description
Comparative cross sectional study
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will be conducted at the department of Obstetrics and Gynecology of Ain shams university and Zagazig university and some private centres for the treatment of infertility. It will include 400 women, divided into two groups (control group and clinical group) starting from January 2016.
Key inclusion criteria (10 listed)
- Pregnant women.
- At least one live birth.
- Age group 20-40 years.
- Infertile women either primary or secondary according to (WHO,2013).
- Age group 20-40ys.
Key exclusion criteria (5 listed)
- Male factor of infertility.
- The women with psychiatric disorders.
- The women with physical and medical disorders.
- The women whose current pregnancy has any problems (e.g. growth retardation, macrosomia, placenta previa, threatened abortion, or preterm labour).
- The women with history of intrauterine fetal death.
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 |
|---|---|---|
| hospital anxiety and depression scaleAlso: emotional distress of women with infertilityDetection of infertility effect on emotional status | Other | – |
Primary outcome
determination of the prevalence of depression among infertile women
Time frame: 6 months
questionnaire will be used to collect qualititiative data from women
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Individual participant dataSharing planned: Yes
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
sherif a akl study director
professor of obstetric and gynecology
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Ain Shams Maternity Hospital.
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 10 inclusion and 5 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 23 Dec 2015. 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 ahmed m bahaa, MD (01099517965 ext. 02, hindlaban@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
determination of the prevalence of depression among infertile women (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2015.