NCT06591637

Brief Summary

Infertile individuals frequently attempt behavioral changes to enhance the effectiveness of their treatment and improve fertility outcomes. Consequently, this study was designed to assess the impact of fertility supportive behavior education, grounded in Watson's Human Care Theory, on healthy lifestyle behaviors and the success rates of in vitro fertilization (IVF) in women with primary infertility

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

September 8, 2024

Last Update Submit

September 11, 2024

Conditions

Infertility, FemaleIVF

Keywords

FertilityWatson's Human Caring TheoryLifestyleNursing Care

Outcome Measures

Primary Outcomes (1)

  • The Health-Promoting Lifestyle Profile II instrument

    The Health-Promoting Lifestyle Profile II (HPLP-II) is a widely-used instrument for evaluation of health behaviour which has been validated in multiple studies. Based on Pender's Health Promotion Model, it conceptualises an individual's health-promoting lifestyle in terms of the following dimensions; health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations and stress management.

    Both groups completed a Health-Promoting Lifestyle Profile instrument and pre-test measures, at the onset of the study. At the end of treatment after embryo transfer they were administered test measures.After 3 months were administered posttest measure

Secondary Outcomes (1)

  • A quantitative human chorionic gonadotropin (HCG or hCG) blood test

    14 days after embryo transfer

Study Arms (2)

intervention group

EXPERIMENTAL

The intervention group received fertility supportive behavior education based on Watson's Theory of Human Caring and was given a booklet titled 'Fertility-Supporting Health Training' at the onset of treatment. In addition to routine nursing care, the researcher provided detailed intervention and guidance regarding the booklet throughout the treatment period.

Behavioral: Fertility supportive behavior education based on Watson's Theory of Human CareProcedure: Routine nursing careDevice: The booklet "Fertility-Supporting Health Training

control group

OTHER

The control group received routine nursing care and was given a booklet titled 'Fertility-Supporting Health Training' at the onset of treatment, but the researcher did not provide any additional intervention or guidance regarding the booklet.

Procedure: Routine nursing careDevice: The booklet "Fertility-Supporting Health Training

Interventions

Fertility supportive behavior education based on Watson's Theory of Human CareBEHAVIORAL

In this study, Watson's Theory of Human Caring guided the development of a care framework and nursing intervention for women with infertility. The researchers adapted the theory and focused on six of the ten carative factors : 1) Adopting values of humanity and devotion; 4) Developing supportive care relationships; 6) Using problem-solving methods for informed decisions; 7) Tailoring teaching to individual needs; 8) Creating a comfortable, peaceful environment; 9) Assisting with basic needs. The nursing care program, integrated with IVF treatments (14-18 days), involved four transpersonal interviews lasting 45-90 minutes each. These interviews were recorded in notes, used to individualize future sessions. The approach included active listening, empathy, and support, with participants encouraged to keep diaries for discussion. Communication was maintained in person, by phone, or email.

intervention group
Routine nursing carePROCEDURE

Routine nursing care during IVF treatment includes: Pre-Treatment Counseling: Providing information and addressing patient questions. Monitoring and Assessment: Regular checks of health, hormone levels, and ovarian function. Medication Administration: Giving prescribed fertility drugs and other medications. Assisting with Procedures: Preparing and assisting with egg retrieval and embryo transfer. Emotional Support: Offering emotional and psychological support. Education: Instructing on medication use, self-care, and recognizing complications. Follow-Up Care: Scheduling and managing follow-up appointments to monitor progress

control groupintervention group
The booklet "Fertility-Supporting Health TrainingDEVICE

This booklet was prepared in line with the relevant literature and contained educational content aimed at improving healthy lifestyle behaviours . The training booklet included information on the effects of factors such as obesity, weakness, exposure to environmentally harmful substances, smoking and caffeine use on fertility and the methods of coping with these factors. In addition, information on how to use proper nutrition, develop exercise habits and cope with stress was provided. The booklet was distributed to the women at at the onset of the study.

control groupintervention group

Eligibility Criteria

Age18 Years - 32 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women have a diagnosis of primary infertility.
  • Women over the age of 18 and under the age of 32.
  • Women able to read and write in Arabic.
  • The cause of infertility must be a male factor.
  • Women who are undergoing assisted reproductive techniques, specifically İn Vitro Fertilization-Intracytoplasmatic Sperm Injection.
  • Women using the same drugs and protocols for IVF treatment.
  • Only women who receive a fresh embryo transfer during their IVF treatment included in the study.

You may not qualify if:

  • Women who have problems with understanding or perception
  • The presence of tubal, uterine or other infertility factors in women
  • Women undergoing a frozen embryo transfer as part of their IVF treatment
  • Women whose pregnancies do not continue or who are diagnosed with a fetal anomaly by the time the healthy lifestyle behaviors scale is re-administered after 3 months excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albasma a private IVF center

Gaza, Palestinian Territories

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

September 8, 2024

First Posted

September 19, 2024

Study Start

March 5, 2023

Primary Completion

August 15, 2023

Study Completion

September 30, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)