EndometriumNCT03081130
Intravenous Laser Irradiation Effect on Treatment Resistant Thin Endometrium
An observational study of Endometrium and Laser, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrium, Laser
- What is being tested?
- Intravenous laser irradiation treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2017to 31 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: We will recruit 30 poor ovarian responders and thin endometrium patients
Who may be able to join
- We will recruit 30 poor ovarian responders and thin endometrium patients
Who cannot join
- women with underlying medical diseases, such as diabetes or hypertension
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital
Kaohsiung City
Kuan-Hao Tsui, M.D., Ph.D., 886-7-3422121, khtsui@vghks.gov.tw
Hsiao-Wen Tsai, M.D.
About this study
Official title: Effects of Intravenous Laser Irradiation on Treatment Resistant Thin Endometrium in Women Undergoing Frozen Thawed Embryo Transfer Cycles
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.
Read the 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.
- Conditions
- Endometrium, Laser
- Being tested
- Intravenous laser irradiation treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous laser irradiation treatmentProcedure or surgery
control group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrium thickness
endometrium thickness evaluated by transvaginal sonography after intervention
Measured: after intervention 1 month and treated with estradiol
Secondary outcomes (1)
pregnancy
pregnancy
Measured: 4 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start1 Feb 2017
- Primary completion31 Jan 2018 (estimated)
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for EndometriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsiao-Wen Tsai, Kaohsiung Veterans General Hospital.
- Investigators
- Kuan-Hao Tsui, Study director, Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081130
- Sponsor's protocol ID
- Laser on thin endometrium
- Status last verified
- Mar 2017
- First submitted
- 9 Mar 2017
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27129096Lebovitz 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.
PubMed 24693854Gleicher 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.
PubMed 23081869Kasius 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.
PubMed 24664156Kazemikhoo 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.
PubMed 27406711Momenzadeh 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.
PubMed 27330692Rikihisa 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.
PubMed 28234842Dahmardehei 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.
PubMed 26868033
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Laser Irradiation on Treatment Resistant Thin Endometrium in Women Undergoing Frozen Thawed Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT03081130
- Acronym / sponsor ID
- Laser on thin endometrium
- Conditions
- Endometrium, Laser
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Jan 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 16 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous laser irradiation treatment | – | Procedure: Intravenous laser irradiation treatmentWe 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. |
| 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 |
Who may qualify
- Ages
- Up to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- We will recruit 30 poor ovarian responders and thin endometrium patients
Key inclusion criteria (1 listed)
- We will recruit 30 poor ovarian responders and thin endometrium patients
Key exclusion criteria (1 listed)
- women with underlying medical diseases, such as diabetes or hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous laser irradiation treatmentcontrol group | Procedure or surgery | Intravenous laser irradiation treatment |
Primary outcome
Endometrium thickness
Time frame: after intervention 1 month and treated with estradiol
endometrium thickness evaluated by transvaginal sonography after intervention
1 secondary outcome
pregnancy
Time frame: 4 weeks after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Background: PubMed 27129096Kudesia 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.
- Background: PubMed 24693854Lebovitz 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.
- Background: PubMed 23081869Gleicher 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.
- Background: PubMed 24664156Kasius 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.
- Background: PubMed 27406711Kazemikhoo 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.
- Background: PubMed 27330692Momenzadeh 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.
- Background: PubMed 28234842Rikihisa 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.
- Background: PubMed 26868033Dahmardehei 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuan-Hao Tsui study director
Department of Obstetrics and Gynecology, Kaohsiung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrium and Laser, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsiao-Wen Tsai (886-7-3422121, drtsai0627@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endometrium thickness (time frame: after intervention 1 month and treated with estradiol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03081130, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.