Quality of LifeNCT07509138
Quality of Life in Women Using LARC Contraception
An observational study of Quality of Life, run by Assiut University.
Trial summary
assessment of quality of life in women using LARC Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Etonogestrel Implant, Levonorgestrel Intrauterine Device and Copper Intrauterine Device
- Type of treatment
- Medical device
- How many people
- 427 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- women aged 18 to 45 years,
- women used LARC contraception,
- women agreed to participate.
Who cannot join
- women using non LARC contraception,
- women had any psychiatric disorder
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Quality of Life in Women Using LARC Contraception: Cross-Sectional Study
assessment of quality of life in women using LARC
Read the 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)
- Conditions
- Quality of Life
- Being tested
- Etonogestrel Implant, Levonorgestrel Intrauterine Device, Copper Intrauterine Device
- Keywords
- LARC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Etonogestrel ImplantDevice
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 DeviceDevice
Insertion of a levonorgestrel-releasing intrauterine device into the uterine cavity by a trained healthcare provider for long-acting contraception.
Copper Intrauterine DeviceDevice
Insertion of a copper intrauterine device into the uterine cavity by a trained healthcare provider as a non-hormonal long-acting contraceptive method.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Etonogestrel Implant | |
| 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. Receives: Device: Levonorgestrel Intrauterine Device | |
| 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. Receives: Device: Copper Intrauterine Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 3 months after contraceptive method initiation
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: Baseline and 3 months after method initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 427 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohamed Abdelazeim, Assiut University
- Investigators
- Elwani Elderemy, Professor, Study director, Assiut UniversityMansour Ahmed, Professor, Study director, Assiut UniversityAbdelrahman Mahmoud, lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509138
- Sponsor's protocol ID
- LARC-Contraception-QoL
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Women Using LARC Contraception: Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07509138
- Acronym / sponsor ID
- LARC-Contraception-QoL
- Conditions
- Quality of Life
- Keywords
- LARC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 427 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
assessment of quality of life in women using LARC
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 design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Implanon(Etonogest Implant) | – | Device: Etonogestrel ImplantA 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. |
| LNG-IUD (Levonorgestrel Intrauterine Device) | – | Device: Levonorgestrel Intrauterine DeviceA 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. |
| Cu-IUD (Copper Intrauterine Device) | – | Device: Copper Intrauterine DeviceA 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- women aged 18 to 45 years,
- women used LARC contraception,
- women agreed to participate.
Key exclusion criteria (2 listed)
- women using non LARC contraception,
- women had any psychiatric disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Etonogestrel ImplantInsertion of a single etonogestrel-releasing subdermal contraceptive implant in the upper arm by a trained healthcare provider according to standard clinical practice. | Device | Implanon(Etonogest Implant) |
| Levonorgestrel Intrauterine DeviceInsertion of a levonorgestrel-releasing intrauterine device into the uterine cavity by a trained healthcare provider for long-acting contraception. | Device | LNG-IUD (Levonorgestrel Intrauterine Device) |
| Copper Intrauterine DeviceInsertion of a copper intrauterine device into the uterine cavity by a trained healthcare provider as a non-hormonal long-acting contraceptive method. | Device | Cu-IUD (Copper Intrauterine Device) |
Primary outcome
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
4 secondary outcomes
Proportion of Participants Reporting Dysmenorrhea Assessed by Visual Analogue Scale (VAS) for Pain
Time frame: Baseline and 3 months after method initiation
Mean Dysmenorrhea Severity Score Assessed by Visual Analogue Scale (VAS)
Time frame: Baseline and 3 months after method initiation
Change in Female Sexual Function Index (FSFI) Total Score
Time frame: Baseline and 3 months after method initiation
Change in Depression Subscale Score of the Depression Anxiety Stress Scales-21 (DASS-21)
Time frame: Baseline and 3 months after method initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elwani Elderemy, Professor study director
Assiut University
Mansour Ahmed, Professor study director
Assiut University
Abdelrahman Mahmoud, lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aya Mohamed, master (01024966321, aya.15235669@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.