Use of Hyaluronan Enriched Media for Improving Implantation in Intrauterine Insemination

HEMI Trial: Novel use of Hyaluronan Enriched Media for Improving Implantation in Intrauterine Insemination: A Prospective Randomised Controlled Trial - HEMI Trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079256

Enrollment

264

Registered

2025-01-23

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N972- Female infertility of uterine origin

Interventions

Intervention1: Hyaluronate enriched medium: In the intervention arm of the study, 4-5 days following intrauterine insemination 0.5 ml of Hyaluronate enriched medium will be instilled in the endometr

Eligibility

Inclusion criteria

Inclusion criteria: Female partner of couples with unexplained infertility with BMI less than 30. Having normal tubal patency test, regular ovulation and normal husband semen analysis as per WHO 2010 reference ranges

Exclusion criteria

Exclusion criteria: Female partner of couples with unexplained infertility not willing to participate in the trial

Design outcomes

Primary

Measure	Time frame
To assess the effect of intrauterine instillation of hyaluronic acid enriched media during the biological implantation window on clinical pregnancy rate in intrauterine insemination treatment.Timepoint: To assess the effect of intrauterine instillation of hyaluronic acid enriched media during the biological implantation window on clinical pregnancy rate in intrauterine insemination treatment at 7 weeks of gestation	—

Measure

Time frame

To assess the effect of intrauterine instillation of hyaluronic acid enriched media during the biological implantation window on clinical pregnancy rate in intrauterine insemination treatment.Timepoint: To assess the effect of intrauterine instillation of hyaluronic acid enriched media during the biological implantation window on clinical pregnancy rate in intrauterine insemination treatment at 7 weeks of gestation

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Secondary

Measure	Time frame
To evaluate the effect of intrauterine instillation of hyaluronan enriched media during the biological implantation window on the biochemical pregnancy and ongoing pregnancy rate up to 20 weeks of gestation in intrauterine insemination treatmentTimepoint: Overdue menstruation;To the effect of intrauterine instillation of hyaluronan enriched media during the biological implantation window on miscarriage rate in intrauterine insemination treatment.Timepoint: Loss of pregnancy before 24 week gestation	—

Measure

Time frame

To evaluate the effect of intrauterine instillation of hyaluronan enriched media during the biological implantation window on the biochemical pregnancy and ongoing pregnancy rate up to 20 weeks of gestation in intrauterine insemination treatmentTimepoint: Overdue menstruation;To the effect of intrauterine instillation of hyaluronan enriched media during the biological implantation window on miscarriage rate in intrauterine insemination treatment.Timepoint: Loss of pregnancy before 24 week gestation

—

Countries

India

Contacts

Public ContactDr Navdeep Kaur Ghuman

All India Institute of Medical Sciences , Jodhpur

drnavdeepghuman@gmail.com8107096747

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026