Clinical trial NCT03081130: Intravenous Laser Irradiation Effect on Treatment Resistant Thin Endometrium
Official title: Effects of Intravenous Laser Irradiation on Treatment Resistant Thin Endometrium in Women Undergoing Frozen Thawed Embryo Transfer Cycles
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometrium
Laser
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2017-03-16
Enrollment: 60
Sex: FEMALE
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will recruit 30 poor ovarian responders and thin endometrium patients

Brief summary: We will recruit 30 poor ovarian responders and thin endometrium patients, aged 35-45 year old, and treat with intravascular 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.

Detailed description: Intravenous laser irradiation of blood (ILIB) is the use of He-Ne laser (632.8 nm) via an intravenous catheter for irradiation of the blood with a lower power of 1-5 milliwatt (mW) and a period of 10-90 minutes to promote functional re-generation mitochondria and pro-oxidant/antioxidant equilibrium in living bodies. ILIB was developed experimentally by the Russian researchers and was introduced into clinical practice in 1981. The treatment with He-Ne laser 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. The aid of treatment of acute cerebral infarction, rheumatoid arthritis, arthrosclerosis of the leg, redifferentiation therapy of malignant tumors has been studies for years and over the past 30 years, there are growing studies that has challenging the therapeutic effect of ILIB.

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.

Eligibility criteria: Inclusion Criteria:

* We will recruit 30 poor ovarian responders and thin endometrium patients

Exclusion Criteria:

* women with underlying medical diseases, such as diabetes or hypertension

Primary outcomes:
measure: Endometrium thickness
timeFrame: after intervention 1 month and treated with estradiol
Secondary outcomes:
measure: pregnancy
timeFrame: 4 weeks after embryo transfer
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital
Study officials:
affiliation: Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital
name: Kuan-Hao Tsui
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.