Measurement and characterization of contractions in a non-pregnant uterus by noninvasive electrophysiological measurements of the uterine muscle activity using a small electrode matrix placed on the abdomen. Simultaneous vaginal ultrasonography…
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. reliability of the EHG during different phases of the normal menstrual cycle
in a prospective selected cohort
2. Determine objective changes in electric activity and subsequent endometrial
wave patterns in relation to phase of menstrual cycle (characterization of
waves).
3. Assess the influence of the vaginal microbiome on uterine peristalsis in
infertile and fertile women
Outcomes Phase IIc:
- Uterine contraction parameters (frequency, amplitude, coordination,
direction) pre and post hormonal therapy, and/or prior to embryo transfer
Outcomes Phase III:
- Uterine contraction parameters (frequency, amplitude, coordination,
direction) prior to placement/removal of IUDs or placental remnants
Secondary outcome
1. Identification of prognostic factors for fertility in relation to changes in
electric myometrial during the menstrual cycle.
2. Identifying the role of sex-hormone bloodlevels in the characteristics of
endometrial waves.
Background summary
In spite of major efforts to improve ART (assisted reproductive technology)
over the past 20 years, the overall effectiveness remains below 25-30% per
treatment cycle, even for IVF (in vitro fertilization) which is the most
advanced technique. Most IVF failures remain unexplained. The emotional,
social, and economical implications of a series of repeated IVF failures are
tremendous.
There is significant evidence for major involvement of uterine contractions in
IVF failure. Precise interventions on contractions are possible and might
increase the success rate of IVF. Unfortunately, so far there is no method
suitable for objective, complete, and continuous characterization of uterine
activity during the normal ovulatory cycle.
Developing a method for continuous and objective assessment of uterine
contraction characteristics is an essential step to boost IVF success rates. It
would allow an understanding of the impact of contractions on IVF failure and
would be a necessary prerequisite for tailoring specific treatments.
It is becoming generally accepted that women with benign uterine disorder most
likely have aberrant uterine contractions. This could be an explanation for
fertility issues and other symptoms in these women, however research is scarce.
It is known that symptoms respond well to hormonal therapy, which may have
something to do with changes in uterine contractions. If more was known if/how
these contraction function these could be a potential aetiological mechanism
and/or treatment target.
Furthermore, recent literature has suggested a potential effect of
vaginal/uterine microbiome on uterine contractions. This is been little
researched in IVF patients but is a trending topic, let alone being researched
using an objective quantitative method.
Study objective
Measurement and characterization of contractions in a non-pregnant uterus by
noninvasive electrophysiological measurements of the uterine muscle activity
using a small electrode matrix placed on the abdomen. Simultaneous vaginal
ultrasonography recordings will be performed.
Objectives Phase IIc:
Measurement and characterisation of uterine contraction via transvaginal
ultrasound in benign uterine disorders(adenomyosis, leiomyomas, congenital
uterine anomalies), before and after hormonal treatment, and/or in the context
of IVF
Phase III:
Measurement and characterisation of uterine contractions via transvaginal
ultrasound in women with intrauterine IUDs or placental remnants prior to
removal/placement.
Study design
An observational prospective study in a selected cohort
Study burden and risks
There are no risks associated with participation.
Michelangelolaan 2
Eindhoven 5623EJ
NL
Michelangelolaan 2
Eindhoven 5623EJ
NL
Listed location countries
Age
Inclusion criteria
- Phase I: Age 18-40 years, patients under hormonal fertility treatment
- Phase IIa: Age 18-40 years, healthy women with regular natural cycle.
- Phase IIb: Age >18 years, hysterectomy
- Phase IIc: Age 18-40 years, diagnosed with at least one of the following:
adenomyosis, leiomyoma, uterine anomaly
- Optional: under hormonal fertility treatment in the context of IVF
- Phase III:
- Age 18-40 years
- Regular menstrual cycle
- Diagnosed with at least one of the following: adenomyosis, leiomyoma,
(congenital) uterine anomaly, placental remnant AND/OR:
- Wish for intrauterine contraceptive device
- Under hormonal fertility treatment in the context of IVF
Exclusion criteria
General:
- Pregnancy
- Mental disability
- Significant language barrier
Phase Ia:
- Uterine anomalies (congenital or not congenital)
- Uterine pathologies (leiomyomas, adenomyosis, endometriosis)
- Cesarian section in the past, Phase IIa:
- Exclusion criteria of Phase I
- Hormonal medication of any kind,
Phase IIb:
- General + Phase I
- Phase IIc, III: General exclusion criteria
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL52466.100.15 |
| OMON | NL-OMON29437 |