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
About this trial
This is an interventional treatment trial for Infertility
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
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
NCT ID
NCT02418364
First Posted
March 4, 2015
Last Updated
April 12, 2015
Sponsor
Meir Medical Center
Collaborators
Clalit Health Services, Reidman college
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
background
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
background
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
background
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
background
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The Effect of Reflexology Treatments on IVF Outcome
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