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NCT Number: NCT06935968

Effect of Levonorgestrel Intrauterine System on Hemoglobin Level

To study the effect of LNG-IUS on improving iron status in reproductive-aged women presenting for contraception.

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Key information

Conditions

Hemoglobin; Deficiency

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Women come to family planning clinic to insert levonorgestrel intrautrine system and take a blood sample from her to analyse hemoglobin level

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The study will include married women attending the outpatient clinics of the forementioned health facilities for contraception counseling
  • Age between 18 and 45 years
  • Women who choose LNG_IUS for contraception
  • Any parity including nulliparous

Exclusion criteria

  • 1.Women with any inherited hemoglobinopathy (thalassemia, sickle cell anemia) or acquired hemolytic anemia 2.Women with sever iron deficiency anemia requiring immediate treatment 3.Women with any contraindication to Mirena insertion (pelvic inflammatory disease, cervical or vaginal infection, cervical cancer) 4. Any uterine abnormality making LNG_IUS insertion difficult (septate uterus or fibroid distorting the cavity) 5. Women within 6 months of delivery

Treatment and study plan

Levonorgestrel intrautrine system

Device

Insertion of levonorgestrel intrautrine system and take a blood sample from the women to analyse it

Other names: Take a blood sample

Primary outcomes

  1. Change of blood haemoglobin level from time of insertion to 6 months after insertion

    Time frame: 6 months

    To know the effect of LNG-IUDs on hemoglobin level after insertion

Secondary outcomes

  1. Change of serum ferritin level from time of insertion to 6 months after insertionPrevalence of iron deficiency and iron deficiency anemia in women requiring contraception in our community

    Time frame: 6 months

    To know the effect of LNG-IUDs in serum ferritin

Study contacts

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

Essam eldeen Rashad

CONTACT

Mariam Melad

CONTACT

[email protected]

01020214925

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Levonorgestrel Intrautrine System on Hemoglobin Level and Iron Profile on Women Requiring Contraception

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
Apr 20, 2025

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.

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