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

NCT02437435 | Completed DMC

• 2 other identifiers: 1406-VLC-044-CG-1406-VLC-044-CG
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

assisted reproduction; physical therapy; manual therapy; uterine artery; Vascularization Index (VI); Doppler ultrasonography; vocal

Outcome Measures

Primary Outcomes (1)

• Increased uterine vascular flow after application of the Reproductive Physioterapeutic Technique.

  5 minutes after application of Reproductive Therapy Technique Gimilio

Study Arms (2)

Reproductive Technique Gimilio

EXPERIMENTAL

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

Placebo Intervention

PLACEBO COMPARATOR

The researcher puts his right hand on the right shoulder of the patient for 20 times Metronome.

Other: Placebo Intervention

Interventions

Reproductive Technique Gimilio OTHER

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.

Also known as: Uterine Vascular Technique of Gimilio

Reproductive Technique Gimilio

Placebo Intervention OTHER

Patient supine, legs in triple flexion, feet on table. Physical Therapist take contact with his right hand in patient's belly for 5 minutes, without any movement.

Also known as: Placebo Intervention technique

Placebo Intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead
• Instituto Valenciano de Infertilidad, IVI VALENCIA: collaborator

Study Sites (1)

Catholic University of Valencia

Torrent, Valencia, 46900, Spain

Location

Related Publications (19)

• Jones HW Jr, Cooke I, Kempers R, Brinsden P, Saunders D. International Federation of Fertility Societies Surveillance 2010: preface. Fertil Steril. 2011 Feb;95(2):491. doi: 10.1016/j.fertnstert.2010.08.011.

  PMID: 20813358 BACKGROUND

• Faddy MJ, Gosden RG, Gougeon A, Richardson SJ, Nelson JF. Accelerated disappearance of ovarian follicles in mid-life: implications for forecasting menopause. Hum Reprod. 1992 Nov;7(10):1342-6. doi: 10.1093/oxfordjournals.humrep.a137570.

  PMID: 1291557 BACKGROUND

• Budak E, Garrido N, Soares SR, Melo MA, Meseguer M, Pellicer A, Remohi J. Improvements achieved in an oocyte donation program over a 10-year period: sequential increase in implantation and pregnancy rates and decrease in high-order multiple pregnancies. Fertil Steril. 2007 Aug;88(2):342-9. doi: 10.1016/j.fertnstert.2006.11.118. Epub 2007 Feb 28.

  PMID: 17335819 BACKGROUND

• Remohi J, Gallardo E, Guanes PP, Simon C, Pellicer A. Donor-recipient synchronization and the use of gonadotrophin-releasing hormone agonists to avoid the premature luteinizing hormone surge in oocyte donation. Hum Reprod. 1995 Dec;10 Suppl 2:84-90. doi: 10.1093/humrep/10.suppl_2.84.

  PMID: 8745305 BACKGROUND

• El-Mazny A, Abou-Salem N, Elshenoufy H. Three-dimensional power Doppler study of endometrial and subendometrial microvascularization in women with intrauterine device-induced menorrhagia. Fertil Steril. 2013 Jun;99(7):1912-5. doi: 10.1016/j.fertnstert.2013.01.151. Epub 2013 Mar 7.

  PMID: 23465819 BACKGROUND

• Wurn BF, Wurn LJ, King CR, Heuer MA, Roscow AS, Scharf ES, Shuster JJ. Treating female infertility and improving IVF pregnancy rates with a manual physical therapy technique. MedGenMed. 2004 Jun 18;6(2):51.

  PMID: 15266276 BACKGROUND

• Mercier J, Miller K. Mercier therapy helps infertile women achieve pregnancy. Midwifery Today Int Midwife. 2013 Spring;(105):40, 68. No abstract available.

  PMID: 23581202 BACKGROUND

• Nelson KE, Sergueef N, Glonek T. The effect of an alternative medical procedure upon low-frequency oscillations in cutaneous blood flow velocity. J Manipulative Physiol Ther. 2006 Oct;29(8):626-36. doi: 10.1016/j.jmpt.2006.08.007.

  PMID: 17045096 BACKGROUND

• Ivanovski M, Damcevski N, Radevska B, Doicev G. Assessment of uterine artery and arcuate artery blood flow by transvaginal color Doppler ultrasound on the day of human chorionic gonadotropin administration as predictors of pregnancy in an in vitro fertilization program. Akush Ginekol (Sofiia). 2012;51(2):55-60.

  PMID: 23234017 BACKGROUND

• Raine-Fenning NJ, Campbell BK, Clewes JS, Kendall NR, Johnson IR. The reliability of virtual organ computer-aided analysis (VOCAL) for the semiquantification of ovarian, endometrial and subendometrial perfusion. Ultrasound Obstet Gynecol. 2003 Dec;22(6):633-9. doi: 10.1002/uog.923.

  PMID: 14689538 BACKGROUND

• Ely JW, Kennedy CM, Clark EC, Bowdler NC. Abnormal uterine bleeding: a management algorithm. J Am Board Fam Med. 2006 Nov-Dec;19(6):590-602. doi: 10.3122/jabfm.19.6.590.

  PMID: 17090792 BACKGROUND

• Maulik D, Yarlagadda P, Youngblood JP, Ciston P. Comparative efficacy of umbilical arterial Doppler indices for predicting adverse perinatal outcome. Am J Obstet Gynecol. 1991 Jun;164(6 Pt 1):1434-9; discussion 1439-40. doi: 10.1016/0002-9378(91)91421-r.

  PMID: 2048589 BACKGROUND

• Erskine RL, Ritchie JW. Umbilical artery blood flow characteristics in normal and growth-retarded fetuses. Br J Obstet Gynaecol. 1985 Jun;92(6):605-10. doi: 10.1111/j.1471-0528.1985.tb01399.x.

  PMID: 4005201 BACKGROUND

• Koster K, Poulsen Nautrup C, Gunzel-Apel AR. A Doppler ultrasonographic study of cyclic changes of ovarian perfusion in the Beagle bitch. Reproduction. 2001 Sep;122(3):453-61. doi: 10.1530/rep.0.1220453.

  PMID: 11597310 BACKGROUND

• Oldenhave A, Netelenbos C. Pathogenesis of climacteric complaints: ready for the change? Lancet. 1994 Mar 12;343(8898):649-53. doi: 10.1016/s0140-6736(94)92641-7. No abstract available.

  PMID: 7906816 BACKGROUND

• Khaw KT. Epidemiology of the menopause. Br Med Bull. 1992 Apr;48(2):249-61. doi: 10.1093/oxfordjournals.bmb.a072546.

  PMID: 1450870 BACKGROUND

• Grattarola R, Secreto G, Recchione C. Correlation between urinary testosterone or estrogen excretion levels and interstitial cell-stimulating hormone concentrations in normal postmenopausal women. Am J Obstet Gynecol. 1975 Feb 1;121(3):380-1. doi: 10.1016/0002-9378(75)90016-2.

  PMID: 1115152 BACKGROUND

• Gambrell RD Jr. The menopause: benefits and risks of estrogen-progestogen replacement therapy. Fertil Steril. 1982 Apr;37(4):457-74. doi: 10.1016/s0015-0282(16)46149-2.

  PMID: 7040116 BACKGROUND

• Ng EH, Chan CC, Tang OS, Yeung WS, Ho PC. Changes in endometrial and subendometrial blood flow in IVF. Reprod Biomed Online. 2009 Feb;18(2):269-75. doi: 10.1016/s1472-6483(10)60265-9.

  PMID: 19192349 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• César M Gimilio Martínez, D.

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapy

Study Record Dates

• First Submitted: April 15, 2015
• First Posted: May 7, 2015
• Study Start: August 1, 2018
• Primary Completion: June 1, 2019
• Study Completion: January 20, 2020
• Last Updated: December 1, 2022

Record last verified: 2022-11

Locations

ES (1)