Educational and Supportive Care to Depressed Infertile Females

NCT06022640 | Completed

• 1 other identifier: AR200111
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Infertility affects married adults, and In Vitro Fertilization (IVF) is an Assisted Reproductive Technology (ART) that can be treated. Women undergoing IVF are more likely to experience depression. There is a need to reduce depression by supporting and advising sufferers. The aim of this study is to evaluate pharmacist counseling's impact on pregnancy rates in depressed infertile females during IVF treatment.

Conditions

Infertility, Female; Depression; IVF

Keywords

Education; Supportive care; Pharmacist

Outcome Measures

Primary Outcomes (1)

• Pregnancy rate

  The outcome of IVF cycles, as measured by clinical pregnancy rates, was recorded after the intervention

  Baseline, 1-month, 3-month, and 6-month marks following the commencement of treatment.

Secondary Outcomes (2)

• Fertility Quality of Life.

  Baseline, 1-month, 3-month, and 6-month marks following the commencement of treatment.

• Depression status

  Baseline, 1-month, 3-month, and 6-month marks following the commencement of treatment.

Study Arms (2)

Group 1

EXPERIMENTAL

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.

Behavioral: Educational and supportive care

Group 2

NO INTERVENTION

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.

Interventions

Educational and supportive care BEHAVIORAL

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.

Group 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: To be an infertile lady
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Al-Rasheed University College: lead

Study Sites (1)

College of Pharmacy, Mustansiriyah University

Baghdad, 10011, Iraq

Location

Related Publications (3)

• Maleki-Saghooni N, Amirian M, Sadeghi R, Latifnejad Roudsari R. Effectiveness of infertility counseling on pregnancy rate in infertile patients undergoing assisted reproductive technologies: A systematic review and meta-analysis. Int J Reprod Biomed. 2017 Jul;15(7):391-402.

  PMID: 29177241 BACKGROUND

• Al-Homaidan HT. Depression among Women with Primary Infertility attending an Infertility Clinic in Riyadh, Kingdom of Saudi Arabia: Rate, Severity, and Contributing Factors. Int J Health Sci (Qassim). 2011 Jul;5(2):108-15.

  PMID: 23267288 BACKGROUND

• Nkansah N, Mostovetsky O, Yu C, Chheng T, Beney J, Bond CM, Bero L. Effect of outpatient pharmacists' non-dispensing roles on patient outcomes and prescribing patterns. Cochrane Database Syst Rev. 2010 Jul 7;2010(7):CD000336. doi: 10.1002/14651858.CD000336.pub2.

  PMID: 20614422 BACKGROUND

MeSH Terms

Conditions

Infertility, Female; Depression

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Abeer A Rashid, FIBMS

  Al-Mustansiriyah University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2023
• First Posted: September 5, 2023
• Study Start: January 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: September 5, 2023

Record last verified: 2023-08

Locations

IR (1)