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The Effect of Reflexology Treatments on IVF Outcome

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo reflexology treatment
Reflexology treatment
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. women age 18 To 42
  2. women who receive IVF treatment
  3. The number of IVF cycles - up to 7 cycles
  4. Signing an informed consent form.
  5. patient is required to receive at least 4 reflexology treatments until the eggs implant.

Exclusion criteria:

  1. Women under 18 or over 42
  2. patients who had 7 cycles of IVF

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    No Intervention

    Experimental

    Arm Label

    placebo reflexology

    control group

    reflexology treatment

    Arm Description

    Placebo reflexology treatment

    Data will be taken from questionnaires

    Reflexology treatment

    Outcomes

    Primary Outcome Measures

    number of pregnant women in women treated with implantation in IVF
    Does reflexology treatment increase the number of pregnant women in women treated with implantation in IVF

    Secondary Outcome Measures

    endometrial thickness
    number of oocytes
    embryo quality
    Embryo quality measured according to the ESHRE score. Grades 1-4

    Full Information

    First Posted
    March 4, 2015
    Last Updated
    April 12, 2015
    Sponsor
    Meir Medical Center
    Collaborators
    Clalit Health Services, Reidman college
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02418364
    Brief Title
    The Effect of Reflexology Treatments on IVF Outcome
    Official Title
    Randomised ,Blind, Placebo Controlled in Meir Center. Study the Potential of Reflexology Treatments to Help Implant Pregnancy in Ivf Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    May 2017 (Anticipated)
    Study Completion Date
    May 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Meir Medical Center
    Collaborators
    Clalit Health Services, Reidman college

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Infertility is expressed as an inability to conceive or carry a healthy pregnancy to the end. It is often said that the couple suffers from infertility if for a year they could not get a normal pregnancy. 30% of the reasons for this unsuccess are attributed to women, 30% are attributed to men, while the other 40% of cases are attributed to the combination between men and women and for unknown reasons. In women, the source of most of the problems of infertility are associated with different failures in ovulation (early ovulation, lack of ovulation or irregular ovulation). Other reasons are Blocked fallopian tubes (due to endometriosis, infection or surgery), problems in the uterus and endometrium. There is a group of women that apparently does not have the failures described above, and they have infertility that does not include pathological findings. Apparently chronic stress is a potential cause among couples who could not get pregnant (despite 6 months of focused sex) so there is a request for various techniques for reducing stress including yoga and meditation. One common option in various conditions of infertility is in vitro fertilization. This technique is also known as artificial insemination and is the most common technique used in Israel. Data from the Ministry of Health from the last years, indicate that the rate of successful pregnancies after embryo transfer is more than a third (in average), this is from an average of 20 treatment cycles. Researches in alternative medicine are not easy to carry out. The placebo group which is usually the control group tend to be a treatment group by itself and gives effective results than a group that does not receive treatment at all. Carrying out a strict study with a good control group such as reflexology research in multiple sclerosis, has brought significant results in various statistical measures examined in this study (movement, sensory mode and urinary tract symptoms). In the control group the calf was chosen as a place of a massage as a dummy treatment (gynecological place), which prevented contact with specific points of the feet like in patients in the treatment group. This study wishes to answer the research question: Does reflexology treatment increase the chances of pregnancy implantation in women without pathological findings that are treated with IVF. Other questions related to measures that could lead to the implant of pregnancy, are whether reflexology treatment affect the endometrial thickness, number of oocytes and embryo quality. Literature indicates the potential of reflexology treatment on ovulation induction (But requires a good control group and large sample size).
    Detailed Description
    The purpose of the study: Does reflexology treatment increase the chance of pregnancy in women treated with IVF? Research design: To the Study will recruited women who come for IVF treatments. Women who are fit to participate and give their consent, will be randomized to one of three treatment groups: Group 1 - placebo reflexology Group 2 - control group that receives no alternative treatment. Data will be taken from questionnaires Group 3 - will be receiving a built-in protocol reflexology treatment Reflexology treatment can begin at any stage up to the stage of the eggs implantation. If the patient is not pregnant, she will start another reflexology treatment cycle. Reflexology treatment will be minimum 4 treatments and up to six treatments for every cycle. Rate treatment will be two or three times a week. The patient can receive reflexology treatment for three cycles of IVF. Research tools and methods Photo of feet before the first treatment and before final treatment Permanent set by 4 parameters Questionnaire: to be transferred at baseline and after treatment and will be in a state of double blinded. There will be no connection between the treatment protocol and questionnaires. At the end of the study, the analysis and cross checking data will form their own measurements. Quality of Life Questionnaire Questionnaire "dhak" Mind-body questionnaire Family support questionnaire Medical tests (measurements taken any way and will be used for the study): blood tests, medical record indicating that there is no pathological findings, ultrasound, endometrial thickness, number of follicles, number of oocytes and embryo quality. Evaluation of Participants: 80 - experimental group 80 - a control group that receives no alternative treatment 80 - a group that receives a placebo treatments Duration of participation in the study: Six months Treatment protocol: The treatment strengthens the natural healing of the body, in that it strengthens the blood flow and the release of endorphins, which can reduce pain, stress relaxation and a general feeling better (wellbeing). Recently a promising theory was added, a theory called Nerve Impulse the suggests that pressure points in the foot improve neural connection to other parts of the body through the autonomic nervous system. The autonomic nervous system, regulates body systems that are under unaware control such as respiratory, heart rate and blood pressure systems which are sensitive to pressure and vibration in accordance with Physical and psychological changes, and able to control the sympathetic system and moderate the fight or flight response. Recent meta-analysis that scanned many articles pointed out that there is no unity in studies about reflexology, that there are a wide range of parameters, methods and measurements of efficacy .Therapeutic Touch are complex and it is difficult to maintain such double-blind trials. Therefore, there is a great need for maintaining the uniformity of treatment. In the investigators' study, will be responsible coordinator of reflexology, Rachel Hoddov, to teach and train coaches participating in the study protocol the standard treatment in a way that will allow a free hand. In addition, Placebo treatment will be in superficial areas in particular, and will be directed to organs and organ systems which are not relevant to the research topic.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infertility

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    240 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    placebo reflexology
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo reflexology treatment
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Data will be taken from questionnaires
    Arm Title
    reflexology treatment
    Arm Type
    Experimental
    Arm Description
    Reflexology treatment
    Intervention Type
    Other
    Intervention Name(s)
    Placebo reflexology treatment
    Intervention Description
    Placebo reflexology treatment will be done in the same rate as the reflexology treatment itself, but will be superficial in particular,and will be directed to organs and organ systems which are not relevant to the research topic.
    Intervention Type
    Other
    Intervention Name(s)
    Reflexology treatment
    Intervention Description
    Reflexology treatment will be done until the eggs implant. If the patient is not pregnant, she will start another reflexology treatment cycle. There will be minimum 4 and up to 6 reflexology treatments in every IVF cycle (maximum three IVF cycles) . Rate treatment will be two or three times a week.
    Primary Outcome Measure Information:
    Title
    number of pregnant women in women treated with implantation in IVF
    Description
    Does reflexology treatment increase the number of pregnant women in women treated with implantation in IVF
    Time Frame
    6 Months
    Secondary Outcome Measure Information:
    Title
    endometrial thickness
    Time Frame
    6 months
    Title
    number of oocytes
    Time Frame
    6 months
    Title
    embryo quality
    Description
    Embryo quality measured according to the ESHRE score. Grades 1-4
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    42 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: women age 18 To 42 women who receive IVF treatment The number of IVF cycles - up to 7 cycles Signing an informed consent form. patient is required to receive at least 4 reflexology treatments until the eggs implant. Exclusion criteria: Women under 18 or over 42 patients who had 7 cycles of IVF
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Liat Edry, PhD
    Phone
    0508520296
    Email
    liatedry@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    7490200
    Citation
    Templeton A. Infertility-epidemiology, aetiology and effective management. Health Bull (Edinb). 1995 Sep;53(5):294-8.
    Results Reference
    background
    PubMed Identifier
    19740047
    Citation
    Ernst E. Is reflexology an effective intervention? A systematic review of randomised controlled trials. Med J Aust. 2009 Sep 7;191(5):263-6. doi: 10.5694/j.1326-5377.2009.tb02780.x.
    Results Reference
    background
    PubMed Identifier
    17459741
    Citation
    Poole H, Glenn S, Murphy P. A randomised controlled study of reflexology for the management of chronic low back pain. Eur J Pain. 2007 Nov;11(8):878-87. doi: 10.1016/j.ejpain.2007.01.006. Epub 2007 Apr 24.
    Results Reference
    background
    PubMed Identifier
    12926840
    Citation
    Siev-Ner I, Gamus D, Lerner-Geva L, Achiron A. Reflexology treatment relieves symptoms of multiple sclerosis: a randomized controlled study. Mult Scler. 2003 Aug;9(4):356-61. doi: 10.1191/1352458503ms925oa.
    Results Reference
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    PubMed Identifier
    18565520
    Citation
    Holt J, Lord J, Acharya U, White A, O'Neill N, Shaw S, Barton A. The effectiveness of foot reflexology in inducing ovulation: a sham-controlled randomized trial. Fertil Steril. 2009 Jun;91(6):2514-9. doi: 10.1016/j.fertnstert.2008.04.016. Epub 2008 Jun 20.
    Results Reference
    background
    PubMed Identifier
    10460981
    Citation
    Sudmeier I, Bodner G, Egger I, Mur E, Ulmer H, Herold M. [Changes of renal blood flow during organ-associated foot reflexology measured by color Doppler sonography]. Forsch Komplementarmed. 1999 Jun;6(3):129-34. doi: 10.1159/000021238. German.
    Results Reference
    background
    PubMed Identifier
    22164810
    Citation
    Hughes CM, Krirsnakriengkrai S, Kumar S, McDonough SM. The effect of reflexology on the autonomic nervous system in healthy adults: a feasibility study. Altern Ther Health Med. 2011 May-Jun;17(3):32-7.
    Results Reference
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    PubMed Identifier
    22261925
    Citation
    Sliz D, Smith A, Wiebking C, Northoff G, Hayley S. Neural correlates of a single-session massage treatment. Brain Imaging Behav. 2012 Mar;6(1):77-87. doi: 10.1007/s11682-011-9146-z.
    Results Reference
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    PubMed Identifier
    24883067
    Citation
    McCullough JE, Liddle SD, Sinclair M, Close C, Hughes CM. The physiological and biochemical outcomes associated with a reflexology treatment: a systematic review. Evid Based Complement Alternat Med. 2014;2014:502123. doi: 10.1155/2014/502123. Epub 2014 May 5.
    Results Reference
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    The Effect of Reflexology Treatments on IVF Outcome

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