Quality of Life in Women Using LARC Contraception

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

assessment of quality of life in women using LARC

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life
• Intervention / Treatment: Device: Etonogestrel Implant; Device: Levonorgestrel Intrauterine Device; Device: Copper Intrauterine Device

Detailed Description

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)

• Study Type: Observational
• Enrollment (Estimated): 427

Contacts and Locations

• Study Contact: Name: Aya Mohamed, master; Phone Number: 01024966321; Email: aya.15235669@med.aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Arabic-speaking women using long-acting reversible contraceptives (LARCs) at family planning clinic Assiut university, family planning clinic Diuriut central hospital located in Assiut governorate Egypt during the study period

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Implanon(Etonogest Implant); A hormonal subdermal contraceptive implant releasing etonogestrel (progestin-only). The implant is inserted under the skin of the upper arm and provides continuous contraception for up to 3-5 years. It works by suppressing ovulation, thickening cervical mucus, and thinning the endometrium. This method is commonly used by women seeking long-acting reversible contraception (LARC) with minimal user action. Participants using this method for at least 3 months will be included in this cohort.	Device: Etonogestrel Implant; Insertion of a single etonogestrel-releasing subdermal contraceptive implant in the upper arm by a trained healthcare provider according to standard clinical practice.
LNG-IUD (Levonorgestrel Intrauterine Device); A hormonal intrauterine device (IUD) that releases levonorgestrel locally inside the uterus (e.g., Mirena or Kyleena). The device provides long-term contraception for approximately 3-8 years depending on the model. Its mechanism primarily involves endometrial thinning leading to reduced menstrual bleeding, with partial suppression of ovulation. It is commonly preferred for women who require contraception along with management of heavy menstrual bleeding. Participants using the LNG-IUD for at least 3 months will be included in this cohort.	Device: Levonorgestrel Intrauterine Device; Insertion of a levonorgestrel-releasing intrauterine device into the uterine cavity by a trained healthcare provider for long-acting contraception.
Cu-IUD (Copper Intrauterine Device); A non-hormonal copper intrauterine device (e.g., ParaGard or TCu-380A) used for long-term contraception. The device releases copper ions that are toxic to sperm, creating an inflammatory uterine environment that prevents fertilization and implantation. The contraceptive effect can last 5-12 years depending on the model. This method is commonly chosen by women who prefer hormone-free contraception or require an emergency contraception option. Participants using the copper IUD for at least 3 months will be included in this cohort.	Device: Copper Intrauterine Device; Insertion of a copper intrauterine device into the uterine cavity by a trained healthcare provider as a non-hormonal long-acting contraceptive method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Total Score at 3 Months Post-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	Baseline and 3 months after contraceptive method initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Reporting Dysmenorrhea Assessed by Visual Analogue Scale (VAS) for Pain	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).	Baseline and 3 months after method initiation
Mean Dysmenorrhea Severity Score Assessed by Visual Analogue Scale (VAS)	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).	Baseline and 3 months after method initiation
Change in Female Sexual Function Index (FSFI) Total Score	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.	Baseline and 3 months after method initiation
Change in Depression Subscale Score of the Depression Anxiety Stress Scales-21 (DASS-21)	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	Baseline and 3 months after method initiation

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Elwani Elderemy, Professor, Assiut University; Study Director: Mansour Ahmed, Professor, Assiut University; Study Director: Abdelrahman Mahmoud, lecturer, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: March 15, 2026
• First Submitted That Met QC Criteria: March 28, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: LARC
• Additional Relevant MeSH Terms: Equipment and Supplies; Intrauterine Devices, Medicated; Intrauterine Devices; Contraceptive Devices, Female; Contraceptive Devices; Intrauterine Devices, Copper
• Other Study ID Numbers: LARC-Contraception-QoL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No