Intravenous Laser Irradiation Effect on Treatment Resistant Thin Endometrium

NCT03081130 | Unknown

• 1 other identifier: Laser on thin endometrium
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrium; Laser

Outcome Measures

Primary Outcomes (1)

• Endometrium thickness

  endometrium thickness evaluated by transvaginal sonography after intervention

  after intervention 1 month and treated with estradiol

Secondary Outcomes (1)

• pregnancy

  4 weeks after embryo transfer

Study Arms (2)

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.

Procedure: Intravenous laser irradiation treatment

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

Interventions

Intravenous laser irradiation treatment PROCEDURE

control group

Intravenous laser irradiation treatment

Eligibility Criteria

• Age: Up to 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit 30 poor ovarian responders and thin endometrium patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kaohsiung Veterans General Hospital.: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

RECRUITING

Related Publications (8)

• 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.

  PMID: 27129096 BACKGROUND

• 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.

  PMID: 24693854 BACKGROUND

• 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.

  PMID: 23081869 BACKGROUND

• 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.

  PMID: 24664156 BACKGROUND

• 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.

  PMID: 27406711 BACKGROUND

• 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.

  PMID: 27330692 BACKGROUND

• 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.

  PMID: 28234842 BACKGROUND

• 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.

  PMID: 26868033 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

Study Officials

• Kuan-Hao Tsui

  Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital

  STUDY DIRECTOR

Central Study Contacts

Hsiao-Wen Tsai

CONTACT

886-7-3422121; drtsai0627@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Hsiao-Wen Tsai

Study Record Dates

• First Submitted: March 9, 2017
• First Posted: March 16, 2017
• Study Start: February 1, 2017
• Primary Completion: January 31, 2018
• Study Completion: March 31, 2018
• Last Updated: March 16, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)