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Investigating the effects of adding visceral manual therapy to routine pelvic physiotherapy compared to pharmacotherapy in improving uterine blood supply, and pregnancy outcomes in women with recurrent failure of implantation (RIF) with increased uterine artery resistance: a randomized clinical trial.

Protocol summary

Study aim
Determine the effect of adding visceral manual therapy to the routine pelvic physiotherapy program compared to pharmacotherapy in improving uterine artery blood flow and pregnancy outcomes in women with a history of recurrent implantation failure (RIF).
Design
A three-arm, with control group, with parallel-group, single-blind and randomized clinical trial on 33 infertile women
Settings and conduct
On the tenth day of menstruation the variables will be checked. After performing the mentioned interventions on the 10th day of menstruation in all three groups, the variables will be checked again. After embryo implantation, chemical pregnancy rate, the number of gestational sacs, abortion, ectopic pregnancy and fetal growth up to 12 weeks of pregnancy will be recorded. Blinding: The laboratory expert, sonographer and statistical analystwill be blinded to the allocation of the intervention groups.
Participants/Inclusion and exclusion criteria
Having age between 20- 40 years, history of at least 2 failed transfers, 2 embryo grade A or B ,uterine artery resistance above 1.76.
Intervention groups
-Control group (C): only the Estrogen. -Common pelvic physiotherapy (PT) :pharmacotherapy and usual pelvic physiotherapy including electrotherapy, TECAR therapy, and pelvic floor exercises -Visceral manual therapy along with usual pelvic physiotherapy(VM/PT): pharmacotherapy, pelvic physiotherapy and manual visceral therapy -Embryo implantation: 2 or 3 grade A or B embryos will be transferred to the uterus in the cleavage stage.
Main outcome variables
Primary outcomes: arterial resistance and plasticity index, peak systolic velocity, end diastolic velocity, endometrial thickness. Secondary consequences: Endometrial pattern, sexual function, depression, quality of life, successful pregnancy, implantation rate, number of gestational sacs and fetal growth up to 12 weeks of pregnancy.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230206057338N2
Registration date: 2024-08-19, 1403/05/29
Registration timing: prospective

Last update: 2024-08-19, 1403/05/29
Update count: 0
Registration date
2024-08-19, 1403/05/29
Registrant information
Name
Zahra Chakeri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3252 5343
Email address
z.chakeri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-10, 1403/06/20
Expected recruitment end date
2024-11-10, 1403/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of adding visceral manual therapy to routine pelvic physiotherapy compared to pharmacotherapy in improving uterine blood supply, and pregnancy outcomes in women with recurrent failure of implantation (RIF) with increased uterine artery resistance: a randomized clinical trial.
Public title
Investigating the effect of visceral manual therapy in improving uterine blood supply and pregnancy outcomes in infertile women with the problem of increased resistance of uterine vessels
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-40 years Having at least two history of failed transfers Having 2 grade A or B embryo for transfers Having uterine artery resistance above 1.76
Exclusion criteria:
Having any of the cases of congenital anomaly of the uterus Having fibroids or any intrauterine lesions Having severe endometriosis Having uterine myomas Having uterine adenomyosis Having ovarian cysts and antral follicles larger than 12 mm in size having severe ovulation disorder including long-term oligoamenorrhea, premature ovarian failure, and hypothalamic amenorrhea Having any internal diseases related to blood flow disorders such as diabetes and dyslipidemia, anorexia, smoking and alcohol consumption. Having special diets such as vegetarianism Having autoimmune disease Having hypertension and coagulation disorders Having intrauterine adhesions (Asherman's syndrome) Having organic injuries Having uterine dysplasia Having mental illnesses Having mental disorders Having severe depression Having contraindications for estrogen therapy Having anemia Having hyperthyroidism Having heart disease Having liver disease Having kidney disease Having others diseases that lead to decreased menstruation. If the embryos are not Grade A or B after resuscitation, if the thickness of the endometrium is less than 6 mm on the day of transfer, or if they do not follow the prescribed treatment (such as a mistake in taking or omitting intervention or examination sessions) they are not included in the study.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 33
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: Block randomization method will be used for randomization. Random blocks with variable block size (block size 3-6-9) will be used. Central randomization will be performed using a secure, web-based randomization system with an allocation ratio of 1:1:1. The allocation sequence will be created by a person who is not involved in the study process and using random numbers generated by the computer.The selection of blocks will continue until the division of 33 patients into three groups (pelvic physiotherapy intervention group (PT), visceral manual therapy intervention group with pelvic physiotherapy (VM/PT) and conventional pharmacotherapy control group (C)).The selected blocks will be recorded in order and in the created sequence, each PT, VM/PT and C letter will be assigned a number from 1 to 33. Due to the unpredictability of the sequence created by the block randomization method, all researchers except the allocator will remain unaware of the size and order of the blocks. Grouping: In order to hide the allocation[4], the type of intervention received will be written on sheets and put into sealed envelopes by a person who is not involved in the study. Envelopes will be numbered consecutively. The envelopes will be opened by the infertility gynecologist in the order in which the participants enter the study, and the type of intervention will be determined and prescribed for the participants. The letter (PT) indicates the allocation in the pelvic physiotherapy intervention group, the letter (VM/PT) indicates the allocation in the intervention group of visceral manual therapy along with pelvic physiotherapy, and the letter (C) indicates the allocation of the conventional pharmacotherapy control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the nature of the study, it was impossible to blind the participants, the gynecologist and the therapist who applied manual visceral therapy. However, the laboratory expert, the sonographer and statistical analyst will be blinded to the allocation of the intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, 29 Bahman Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2024-07-10, 1403/04/20
Ethics committee reference number
IR.TBZMED.REC.1403.276

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97.2
ICD-10 code description
Female infertility of uterine origin

Primary outcomes

1

Description
Investigating the state of uterine blood supply (arterial resistance index, arterial pulse index, peak systolic velocity, end-diastolic velocity)
Timepoint
before intervention (10th day of of menstruation), after intervention (10th day of of menstruation)
Method of measurement
Transvaginal ultrasound

2

Description
Endometrial thickness
Timepoint
before intervention (10th day of of menstruation), after intervention (10th day of of menstruation)
Method of measurement
Transvaginal ultrasound

3

Description
Successful pregnancy
Timepoint
14 days after embryo transfer in cleavage stage and 12 days after embryo transfer in blastocyst stage
Method of measurement
Measuring serum BHCG level and checking the ratio of cases with a positive result (BHCG level ≥ 25 [10]mIU/ml) to all transferred cases

4

Description
Implantation rate
Timepoint
Fifth week of pregnancy
Method of measurement
The ratio of the number of intrauterine gestational sacs observed by vaginal ultrasound in the fifth week of pregnancy divided by the number of embryos transferred

5

Description
Fetal growth
Timepoint
Up to the 12th week of pregnancy
Method of measurement
Ultrasound

Secondary outcomes

1

Description
Endometrial pattern
Timepoint
At the beginning of the intervention (day 10 of menstruation), at the end of the intervention (day 10 of menstruation)
Method of measurement
Using transvaginal ultrasound

2

Description
sexual performance index
Timepoint
At the beginning of the intervention (day 10 of menstruation), at the end of the intervention (day 10 of menstruation)
Method of measurement
FSFI index

3

Description
level of depression
Timepoint
At the beginning of the intervention , at the end of the intervention
Method of measurement
BDI questionnaire

4

Description
quality of life
Timepoint
At the beginning of the intervention , at the end of the intervention
Method of measurement
SQOL-F questionnaire

Intervention groups

1

Description
Control group: pharmacotherapy group (C): Group C receives only the usual pharmacotherapy. Estrogen in the form of estradiol 2 mg tablets will start on the second day of the menstrual cycle. On the second day of the cycle, 2 tablets and from the third day of the cycle, 3 tablets of estradiol will be prescribed per day.
Category
Treatment - Drugs

2

Description
Intervention group: Pelvic Physiotherapy Routine Treatment (PT): For this group, in addition to pharmacotherapy, routine pelvic physiotherapy treatment including electrotherapy, TECAR therapy and pelvic floor exercises will be performed. Pelvic floor physiotherapy will be performed twice a week for one menstrual cycle by a pelvic physiotherapist who is blinded to group allocation. For electrotherapy, electric current with a carrier frequency of 150 Hz, a closed frequency of 2 Hz, a pulse duration of 250 milliseconds and a variable amplitude between 0 and 90 will be used for 30 minutes.Electrical stimulation will be done using a vaginal electrode. The patient is placed in a supine position with bent knees. The pelvic floor physiotherapist pours the required amount of lubricating gel on the vaginal electrode and inserts the electrode into the vagina. Then the device is turned on with the mentioned settings and the intensity of the current is increased to the threshold of the patient's tolerance. For the TECAR therapy, heat is provided using capacitor electrodes with a frequency of 300 kHz for 20 minutes. For this, we first cover the abdomen and sacrum using a layer of special cream for the device. Then, a passive metal electrode is placed in the sacrum area and the active unipolar electrode with a diameter of 0.5 cm is moved around the uterus and ovaries by the pelvic floor physiotherapist.Pelvic floor exercises are divided into four phases. The proprioceptive phase in the first week includes proprioceptive exercises to adequately understand the exercises and perform fast and slow contractions. The simple phase in the second week aims to improve the control of fast and slow contractions during simple performance activities. The advanced phase in the third week, in which functional exercises with a greater range are performed. The strength phase is done in the last week to increase the strength of the contraction. In all sessions, contractions will be performed for slow and fast fibers.
Category
Treatment - Devices

3

Description
Intervention group: visceral manual therapy along with usual pelvic physiotherapy treatment (VM/PT): drug treatment and pelvic physiotherapy will also be done for this group. Then, another therapist skilled in manual therapy evaluates the pelvic area, spine, thoracolumbar fascia, viscera, and uterus and records the results. He then begins manual visceral therapy procedures for the VM/PT intervention group. Touch treatment begins with the hearing hand and touching the area and checking the motility and mobility of the uterus, ovaries, bladder, intestine and ligaments related to the uterus (broad ligament, suspensory ligament). By observing tissue resistance or pain in each part, visceral manual therapy is performed on the visceral fascia of the abdomen and pelvis, using slow and deep mobilization. Treatment techniques include uterine fundus technique, treatment of the ovaries and broad ligament, mobilization of the uterus using the lower limbs, release of the abductor hole, fallopian tube motility, release of the bladder and sacrum, release of the pubovesical ligament, stretching of the ureter in the sitting position, and release of the umbilical ligament. is Each of the techniques is performed for 4 to 5 minutes according to the needs of the patient. The visceral manual therapy will be performed 2 times a week, each time for 40 to 50 minutes during a menstrual cycle.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Teaching Hospital, Tabriz
Full name of responsible person
Zahra Chakeri
Street address
29 Bahman Blvd, Tabriz University of Medical Sciences, Faculty of Rehabilitation
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 914 159 0104
Email
z.chakeri@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Street address
29 Bahman Blvd, Tabriz University of Medical Sciences, Faculty of Rehabilitation
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 912 565 4971
Email
faribaghaderi.pt@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Chakeri
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
29 Bahman Blvd, Faculty of Rehabilitation, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 914 692 7861
Email
z.chakeri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University of Medical Sciences, Faculty of Rehabilitation, 29 bahman Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 2072
Email
faribaghaderi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Chakeri
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University of Medical Sciences, Faculty of Rehabilitation, 29 bahman Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 914 692 7861
Email
z.chakeri@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Only part of the information related to the main outcome can be shared.
When the data will become available and for how long
Access starts 6 months after the publication of the article
To whom data/document is available
The data will only be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Additional analyses
From where data/document is obtainable
email addresses: z.chakeri@gmail.com
What processes are involved for a request to access data/document
2 to 3 weeks after the request email
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