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Physiotherapy Treatment for Uterine Blood Flow Improved Dimensional Ultrasound Evaluated With Angiography

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ClinicalTrials.gov Identifier: NCT02437435
Recruitment Status : Unknown
Verified May 2016 by César Gimilio, University of Valencia.
Recruitment status was:  Active, not recruiting
First Posted : May 7, 2015
Last Update Posted : May 17, 2016
Sponsor:
Collaborator:
Instituto Valenciano de Infertilidad, IVI VALENCIA
Information provided by (Responsible Party):
César Gimilio, University of Valencia

Brief Summary:

Ivanovski shows that by studying the vascular impedance can calculate the optimal uterine receptivity in IVF. A reduced vascular resistance and increased blood flow rate improves the chance of pregnancy.

Dr. Luis T. Mercé says: "After evaluating 40 cycles of IVF (In Vitro Fertilization) have found that the pregnancy rates increases with increasing endometrial volume. It has also advocated that the endometrial blood flow better reflects uterine receptivity, since the endometrium is where will take place the embryo implantation. Merce also claims to have found that the pregnancy rate increases with increasing endometrial volume and no pregnancies were achieved with endometrial volume less than 3 ml.

These statements motivate us to perform a research project to monitor changes that occur in the uterine endometrial vascularization and subendomertial vascularization after applying a manual physiotherapic technique in menopausal women.

Various authors report that by osteopathic techniques applied on visceral structures, vascular flow rate of the treated bodies increased.

In the literature there are not articles on the subject at hand, but there are references to the manual techniques in the treatment of women with infertility where they state that the manual action for lymphatic congestion in the pelvic region facilitates pregnancy in women infertile.

The practice of visceral osteopathy offers the possibility of accessing the treatment of uterine functional disorders, as well as structures such as uterine ligaments. They influence the fluidic efficiency of uterine arteriovenous system. According to Salamon E., W. Zhu and Stefano GB., provides enough tools to improve the movement of fluids and uterine vascularization.


Condition or disease Intervention/treatment Phase
Infertility Other: Reproductive Technique Gimilio Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Physiotherapy Treatment to Improve the Flow on Vascular Area of the Endometrial / Subendometrial in Uterus of Infertile Women With Hypoestrogenemia Evaluated by Three-dimensional Ultrasound Angiography.
Study Start Date : April 2015
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Experimental: Reproductive Technique Gimilio

Patient supine, legs in triple flexion, feet on table, controlling legs left hand and right hand bent on uterine body contact.

Both hands catch utero withdrawal into one on another with arms outstretched. Fixed uterus right hand, left hand, with levers legs combines lateroflexion-rotation parameters of lumbar spine to improve uterine ligaments stretch, repeat technique to tissue relaxation. Then perform massage-cranial caudo zigzag with anteroposterior thrust. (overall hemodynamic maneuver). Finally do anteroposterior pumping about uterine body generating positive and negative pressures.

Hand therapist will keep in touch at all times on the suprapubic region of the patient.

Other: Reproductive Technique Gimilio

Patient supine, legs in triple flexion, feet on table, controlling legs left hand and right hand bent on uterine body contact.

Both hands catch utero withdrawal into one on another with arms outstretched. Fixed uterus right hand, left hand, with levers legs combines lateroflexion-rotation parameters of lumbar spine to improve uterine ligaments stretch, repeat technique to tissue relaxation. Then perform massage-cranial caudo zigzag with anteroposterior thrust. (overall hemodynamic maneuver). Finally do anteroposterior pumping about uterine body generating positive and negative pressures.

Hand therapist will keep in touch at all times on the suprapubic region of the patient.

Other Name: Uterine Vascular Technique of Gimilio

Placebo Comparator: Placebo technique
The researcher puts his right hand on the right shoulder of the patient for 20 times Metronome.
Other: Reproductive Technique Gimilio

Patient supine, legs in triple flexion, feet on table, controlling legs left hand and right hand bent on uterine body contact.

Both hands catch utero withdrawal into one on another with arms outstretched. Fixed uterus right hand, left hand, with levers legs combines lateroflexion-rotation parameters of lumbar spine to improve uterine ligaments stretch, repeat technique to tissue relaxation. Then perform massage-cranial caudo zigzag with anteroposterior thrust. (overall hemodynamic maneuver). Finally do anteroposterior pumping about uterine body generating positive and negative pressures.

Hand therapist will keep in touch at all times on the suprapubic region of the patient.

Other Name: Uterine Vascular Technique of Gimilio




Primary Outcome Measures :
  1. Increased uterine vascular flow after application of the Reproductive Physioterapeutic Technique. [ Time Frame: 5 minutes after application of Reproductive Therapy Technique Gimilio ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Women with hypoestrogenemia and menopausia, being estrogen levels below 20 pg / ml (demonstrated by hormone analysis).
  • Women with morphologically normal uterus.
  • Women without hormonal treatment of any kind.

Exclusion criteria:

  • Patients with any disease in which manipulative therapy is contraindicated. (Contraindicated in the description of the technique)
  • Patients with obesity IMC≥30 kg / m2.
  • High pain to abdominal palpation.
  • Pregnant patients.
  • Patients with bleeding disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02437435


Sponsors and Collaborators
University of Valencia
Instituto Valenciano de Infertilidad, IVI VALENCIA
Investigators
Principal Investigator: César M Gimilio Martínez, D. University of Valencia

Publications:

Responsible Party: César Gimilio, Physical Therapy, University of Valencia
ClinicalTrials.gov Identifier: NCT02437435     History of Changes
Other Study ID Numbers: 1406-VLC-044-CG-
1406-VLC-044-CG ( Other Identifier: IVI Valencia )
First Posted: May 7, 2015    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: May 2016

Keywords provided by César Gimilio, University of Valencia:
assisted reproduction
physical therapy
manual therapy
uterine artery
Vascularization Index (VI)
Doppler ultrasonography
vocal

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female