Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07509138

Quality of Life in Women Using LARC Contraception

assessment of quality of life in women using LARC

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Quality of Life

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

About this study

The ability to control one's fertility is a cornerstone of reproductive health and personal autonomy, fundamentally influencing women's educational, economic, and social trajectories. Modern contraception provides this control, offering a diverse range of methods that allow women and couples to plan if and when to have children. The choice of contraceptive method is a deeply personal decision, often guided by a complex interplay of medical history, lifestyle, personal values, and an individual's priorities regarding efficacy, convenience, and potential side effects (Bangar & Bansal, 2023).

Long-Acting Reversible Contraception (LARC) emerged as a highly effective and increasingly popular category. LARC methods are distinguished by their requirement for administration by a healthcare provider but offer protection against pregnancy for an extended period, ranging from three to ten years, without any ongoing user action. Their "forget-and-forget" nature eliminates the need for daily, weekly, or monthly adherence, resulting in typical-use effectiveness rates that rival those of permanent sterilization. (Francis et al., 2024).

While the clinical effectiveness of LARC in preventing pregnancy is well-established, a comprehensive understanding of its impact must extend beyond this singular outcome to encompass the broader concept of quality of life (QoL). Quality of life is a multidimensional construct that includes physical well-being, psychological state, social relationships, and environmental factors. For a woman using contraception, QoL is affected not only by her confidence in avoiding an unintended pregnancy but also by her experience with method-related side effects (such as changes in bleeding patterns, mood, or weight), the convenience of use, and the overall sense of control over her reproductive health. (Alsammani & Ahmed, 2023)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women aged 18 to 45 years,

women used LARC contraception,

women agreed to participate.

Exclusion criteria

  • women using non LARC contraception,

women had any psychiatric disorder

Treatment and study plan

Etonogestrel Implant

Device

Insertion of a single etonogestrel-releasing subdermal contraceptive implant in the upper arm by a trained healthcare provider according to standard clinical practice.

Levonorgestrel Intrauterine Device

Device

Insertion of a levonorgestrel-releasing intrauterine device into the uterine cavity by a trained healthcare provider for long-acting contraception.

Copper Intrauterine Device

Device

Insertion of a copper intrauterine device into the uterine cavity by a trained healthcare provider as a non-hormonal long-acting contraceptive method.

Primary outcomes

  1. Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Total Score at 3 Months Post-Method Initiation

    Time frame: Baseline and 3 months after contraceptive method initiation

    Assessment of quality of life using the WHOQOL-BREF, a 26-item questionnaire with four domains (physical health, psychological well-being, social relationships, environmental factors).

    Raw domain scores are transformed to a 0-100 scale using the formula: [(raw score - lowest possible)/range] × 100.

    Scale range: 0 to 100 per domain; higher scores indicate better quality of life.

    Primary analysis will compare mean change in overall QoL score from baseline to 3 months between LARC and non-LARC groups

Secondary outcomes

  1. Proportion of Participants Reporting Dysmenorrhea Assessed by Visual Analogue Scale (VAS) for Pain

    Time frame: Baseline and 3 months after method initiation

    Dysmenorrhea incidence defined as VAS score ≥1/10 at 3-month follow-up. Scale: Visual Analogue Scale (VAS), 0 cm = "no pain" to 10 cm = "worst imaginable pain." Reporting: Percentage of participants with VAS ≥1 (binary outcome: yes/no).

  2. Mean Dysmenorrhea Severity Score Assessed by Visual Analogue Scale (VAS)

    Time frame: Baseline and 3 months after method initiation

    Dysmenorrhea incidence defined as VAS score ≥1/10 at 3-month follow-up. Scale: Visual Analogue Scale (VAS), 0 cm = "no pain" to 10 cm = "worst imaginable pain." Reporting: Percentage of participants with VAS ≥1 (binary outcome: yes/no).

  3. Change in Female Sexual Function Index (FSFI) Total Score

    Time frame: Baseline and 3 months after method initiation

    FSFI is a 19-item questionnaire across six domains (desire, arousal, lubrication, orgasm, satisfaction, pain).

    Scale range: Total score 2 to 36; higher scores indicate better sexual function.

    Sexual dysfunction defined as total score ≤26.55. Reporting: Mean change in FSFI total score from baseline to 3 months; domain scores reported separately if clinically relevant.

  4. Change in Depression Subscale Score of the Depression Anxiety Stress Scales-21 (DASS-21)

    Time frame: Baseline and 3 months after method initiation

    DASS-21 depression subscale: 7 items, each rated 0-3; raw sum doubled to align with DASS-42 metric.

    Scale range: 0 to 42; higher scores indicate worse depressive symptoms. Severity cutoffs: Normal (0-9), Mild (10-13), Moderate (14-20), Severe (21-27), Extremely Severe (28+).

    Reporting: Mean change in depression score; proportion exceeding clinical cutoffs

Study contacts

Contact information is provided by the study sponsor or research team.

Aya Mohamed, master

CONTACT

[email protected]

01024966321

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Quality of Life in Women Using LARC Contraception: Cross-Sectional Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.