Educational and Supportive Care to Depressed Infertile Females
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ClinicalTrials.gov Identifier: NCT06022640 |
Recruitment Status :
Completed
First Posted : September 5, 2023
Last Update Posted : September 5, 2023
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Condition or disease | Intervention/treatment | Phase |
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Infertility, Female Depression IVF | Behavioral: Educational and supportive care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | The study included 75 patients in the intervention group who received an educational and supportive program designed by a clinical pharmacist. The intervention group received support through five visits: at admission, monitoring medication, monitoring ovulation, monitoring harmful effects, providing emotional support, and following up after egg retrieval during embryo transfer. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Assessment of Educational and Supportive Care to the Depressed Infertile Females Undergo In Vitro Fertilization Procedure by Clinical Pharmacist: Randomized Clinical Trial |
Actual Study Start Date : | January 1, 2022 |
Actual Primary Completion Date : | July 1, 2022 |
Actual Study Completion Date : | July 1, 2022 |
Arm | Intervention/treatment |
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Experimental: Group 1
The study included 75 patients in the intervention group who received an educational and supportive program designed by a clinical pharmacist. The intervention group received support through five visits: at admission, monitoring medication, monitoring ovulation, monitoring harmful effects, providing emotional support, and following up after egg retrieval during embryo transfer.
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Behavioral: Educational and supportive care
The trial had a total of 75 participants assigned to the intervention group, whereby they were provided with an educative and supporting program specifically developed by a clinical pharmacist. The intervention group was provided with assistance via a series of five visits, which included an initial visit upon admission, subsequent visits for monitoring medication, ovulation, and negative effects, as well as visits dedicated to giving emotional support. Additionally, a follow-up visit was conducted after the egg collecting process and embryo transfer. |
No Intervention: Group 2
The control group included 75 infertile married ladies attending the hospital for the same purpose and managed in the traditional protocol followed by the hospital system. The study assessed the fertility quality of life and depression status of the patients at the beginning and end of the IVF cycle. All patients received frozen embryo transfers (fertilized eggs), not fresh embryos.
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- Pregnancy rate [ Time Frame: Baseline, 1-month, 3-month, and 6-month marks following the commencement of treatment. ]The outcome of IVF cycles, as measured by clinical pregnancy rates, was recorded after the intervention
- Fertility Quality of Life. [ Time Frame: Baseline, 1-month, 3-month, and 6-month marks following the commencement of treatment. ]The assessment of Fertility Quality of Life by: FertiQoL during the start and end times of IVF procedure. The scaled scores range is 0 to 100. Higher scores mean higher quality of life
- Depression status [ Time Frame: Baseline, 1-month, 3-month, and 6-month marks following the commencement of treatment. ]The assessment of depression will be measured by the Center for Epidemiologic Studies Depression Scale (CES-D). Possible range of scores is zero to 60, with the higher scores indicating the presence of more symptomatology
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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | To be an infertile lady |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- To be an infertile lady who spent at least one year after marriage failing to get pregnant and who should then undergo the IVF cycle.
- To be within the reproductive age (18-45 years old); the success rates of IVF tend to decline with increasing age[4].
- To have the ability to read and understand.
- Have depression
Exclusion Criteria:
- Patient with previous failure of I.V.F. procedure.
- Very obese (BMI > 40)[37].
- Patient with psychiatric problems (psychiatric hospital admission, addiction, neurological or other progressive disease, and psychiatric drug use).
- A patient who has a situation that prevents communication (language and hearing problems).
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 ClinicalTrials.gov identifier (NCT number): NCT06022640
Iraq | |
College of Pharmacy, Mustansiriyah University | |
Baghdad, Iraq, 10011 |
Study Director: | Abeer A Rashid, FIBMS | Al-Mustansiriyah University |
Responsible Party: | Al-Rasheed University College |
ClinicalTrials.gov Identifier: | NCT06022640 |
Other Study ID Numbers: |
AR200111 |
First Posted: | September 5, 2023 Key Record Dates |
Last Update Posted: | September 5, 2023 |
Last Verified: | August 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Education Supportive care Pharmacist |
Infertility Infertility, Female Genital Diseases Urogenital Diseases |
Genital Diseases, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |