Intravenous Laser Irradiation Effect on Treatment Resistant Thin Endometrium
NCT ID: NCT03081130
Last Updated: 2017-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2017-02-01
2018-03-31
Brief Summary
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Detailed Description
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The incidence of poor ovarian responders and thin endometrium patients among infertile women has been estimated at 9-24%. It fact, as a result of a lower number of oocytes retrieved, there are fewer embryos to select and transfer and subsequently these patients have lower pregnancy rates per transfer and lower cumulative pregnancy rates. Despite an enormous number of papers on the topic of poor ovarian response and thin endometrium patients have been published in the literature, so far it has been impossible to identify any efficient treatment to improve the ovarian response and the clinical outcome of this group of patients. In most cases the mechanism involved in follicular depletion is still not clear. Previous studies showed that treatment with anti-oxidants could improve the outcomes of the poor ovarian responders and thin endometrium patients, however, the effect is limited. Since ILIB has anti-aging, anti-oxidant and anti-inflammatory effects, we want to know the effect on the poor ovarian responders and thin endometrium women. Through the lower power of He-Ne laser to promote functional re-generation mitochondria and pro-oxidant/antioxidant equilibrium, poor ovarian responders and thin endometrium women may gain the power to improve the ovarian function and endometrium function and higher the pregnancy rates.
We will recruit 30 poor ovarian responders and thin endometrium patients and treat with intravenous laser irradiation of blood (ILIB) via an intravenous catheter for irradiation of the blood under a period of 60 minutes for 10 days. We will evaluate the number and the quality of oocyte retrieved, endometrium thickness and pregnancy rate. The goal of the study is to evaluate whether ILIB is the efficient treatment to improve the ovarian response and the clinical outcome of the poor ovarian responders and thin endometrium patients.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Intravenous laser irradiation treatment
We will recruit 30 poor ovarian responders and thin endometrium patients and treat with intravenous laser irradiation of blood (ILIB) via an intravenous catheter for irradiation of the blood under a period of 60 minutes for 10 days.
Intravenous laser irradiation treatment
control group
control
We will recruit 30 poor ovarian responders and thin endometrium patients and treat with oral estradiol 8 mg per day and oestrogen gel 4 g per day for 14 days
No interventions assigned to this group
Interventions
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Intravenous laser irradiation treatment
control group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
45 Years
FEMALE
Yes
Sponsors
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Kaohsiung Veterans General Hospital.
OTHER
Responsible Party
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Hsiao-Wen Tsai
Dr. Hsiao-Wen Tsai
Principal Investigators
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Kuan-Hao Tsui
Role: STUDY_DIRECTOR
Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital
Locations
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Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Kudesia R, Kuokkanen S. Thin endometrium after radiation therapy as an unresolved treatment challenge: a case report. Gynecol Endocrinol. 2016 Sep;32(9):701-703. doi: 10.1080/09513590.2016.1177813. Epub 2016 Apr 29.
Lebovitz O, Orvieto R. Treating patients with "thin" endometrium - an ongoing challenge. Gynecol Endocrinol. 2014 Jun;30(6):409-14. doi: 10.3109/09513590.2014.906571. Epub 2014 Apr 2.
Gleicher N, Kim A, Michaeli T, Lee HJ, Shohat-Tal A, Lazzaroni E, Barad DH. A pilot cohort study of granulocyte colony-stimulating factor in the treatment of unresponsive thin endometrium resistant to standard therapies. Hum Reprod. 2013 Jan;28(1):172-7. doi: 10.1093/humrep/des370. Epub 2012 Oct 18.
Kasius A, Smit JG, Torrance HL, Eijkemans MJ, Mol BW, Opmeer BC, Broekmans FJ. Endometrial thickness and pregnancy rates after IVF: a systematic review and meta-analysis. Hum Reprod Update. 2014 Jul-Aug;20(4):530-41. doi: 10.1093/humupd/dmu011. Epub 2014 Mar 23.
Kazemikhoo N, Sarafnejad AF, Ansari F, Mehdipour P. Modifying effect of intravenous laser therapy on the protein expression of arginase and epidermal growth factor receptor in type 2 diabetic patients. Lasers Med Sci. 2016 Nov;31(8):1537-1545. doi: 10.1007/s10103-016-2012-x. Epub 2016 Jul 12.
Momenzadeh S, Akhyani V, Razaghi Z, Ebadifar A, Abbasi M. Evaluation of the Effects of Intravenous and Percutaneous Low Level Laser Therapy in the Management of Shoulder Myofascial Pain Syndrome. J Lasers Med Sci. 2016 Winter;7(1):16-20. doi: 10.15171/jlms.2016.04. Epub 2016 Jan 7.
Rikihisa N, Watanabe S, Satoh K, Saito Y, Sakai H. Photosensitizer Effects of Artificial Red Cells on Dye Laser Irradiation in an Animal Model Assuming Port-Wine Stain Treatment. Plast Reconstr Surg. 2017 Mar;139(3):707e-716e. doi: 10.1097/PRS.0000000000003082.
Dahmardehei M, Kazemikhoo N, Vaghardoost R, Mokmeli S, Momeni M, Nilforoushzadeh MA, Ansari F, Amirkhani A. Effects of low level laser therapy on the prognosis of split-thickness skin graft in type 3 burn of diabetic patients: a case series. Lasers Med Sci. 2016 Apr;31(3):497-502. doi: 10.1007/s10103-016-1896-9. Epub 2016 Feb 11.
Other Identifiers
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Laser on thin endometrium
Identifier Type: -
Identifier Source: org_study_id
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