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NCT Number: NCT05873075

Intravascular Laser Irradiation of Blood Use in Poor Ovarian Responders

The aim of this study was to investigate the effects of intravascular laser irradiation of blood on outcomes of in vitro fertilization cycles in poor ovarian responders.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Unrecognized Condition

Age range

30 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan

Kaohsiung City, 886, Taiwan

About this study

Intravascular laser irradiation of blood (ILIB) with He-Ne laser (632.8nm) has been applied on many organs and on the hematologic and immunologic system. Quite a number of both animal and human experiments have demonstrated that ILIB has a wide range of effects, including biostimulation, analgesia, antiallergic effects, immunomodulation, vasodilatation, antihypoxic, anti-oxidant, anti-aging and anti-inflammatory effects.

Poor ovarian responders (PORs) defined as poor or no response to ovarian stimulation had poor prognosis in assisted artificial technique (ART), which is a great challenge in in vitro fertilization (IVF) cycles. Previous studies showed that treatment with anti-oxidants could improve the outcomes of the poor ovarian responders; however, the effect is limited. Since ILIB has anti-aging, anti-oxidant and anti-inflammatory effects, the investigators hypothesize that ILIB may improve ovarian function and oocyte quality in PORs. Therefore, the investigators attempt to explore the effects of ILIB on the IVF outcomes in women with poor ovarian response.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women who undergoes IVF cycles
  • BMI:18-30 kg/m2
  • Diminished ovarian reserve (AFC<5, AMH<1.2 ng/ml)

Exclusion criteria

  • Primary ovarian insufficiency
  • Congenital uterine anomaly
  • Severe intrauterine adhesion
  • Severe male factor (azoospermia)
  • Chromosome anomaly
  • Malignancy
  • Donor cycles

Treatment and study plan

Intravascular laser irradiation of blood

Other

Intravascular laser irradiation of blood via an intravenous catheter for irradiation of the blood under a period of 60 minutes daily for 20 days

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: through study completion, an average of 1 year

    continuous presence of a fetal heartbeat over 12 weeks of a pregnancy

  2. Ovarian reserve marker

    Time frame: through study completion, an average of 1 year

    Anti-mullerian hormone levels

Secondary outcomes

  1. mitochondrial function of cumulus cells

    Time frame: through study completion, an average of 1 year

    Oxygen consumption and adenosine triphosphate production

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

The Effects of Intravascular Laser Irradiation of Blood on Reproductive Outcomes in Poor Ovaria n Responders Undergoing in Vitro Fertilization Cycles

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 24, 2023
Registry last updated
Aug 2, 2024

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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