Intravascular Laser Irradiation of Blood Use in Poor Ovarian Responders

Not Applicable

Active, not recruiting

• Conditions: Unrecognized Condition

• Registration Number: NCT05873075
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-04-27
• Study First Submitted: 2023-05-15
• Study First Submitted QC: 2023-05-15
• Study First Posted: 2023-05-24
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Ovarian reserve marker	through study completion, an average of 1 year	Anti-mullerian hormone levels
Ongoing pregnancy rate	through study completion, an average of 1 year	continuous presence of a fetal heartbeat over 12 weeks of a pregnancy

Secondary Outcome Measures

Name	Time	Method
mitochondrial function of cumulus cells	through study completion, an average of 1 year	Oxygen consumption and adenosine triphosphate production

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan; 🇨🇳 Kaohsiung, Taiwan