No registrations found.
ID
Source
Health condition
Subfertility, IVF, ART, uterine contractions
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Test reliability of electrohysterographic and automated ultrasound for assessing uterine
contractions 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).
Secondary outcome
1. Identification of prognostic features of electrohysterographic and automated ultrasound for the
success rate of fertility treatment.
2. Identifying the role of sex-hormone blood levels in the characteristics of endometrial waves.
Background summary
Successful embryo implantation depends on multiple factors both embryonic and uterine. Uterine
contractions (also called uterine peristalsis or uterine waves) play a role in this mechanism. Studies
have shown that with monitoring and modulation of the contractions, pregnancy chances could
improve. Yet, the lack of a reliable, objective and user-friendly tool to measure these contractions,
hampers its use in daily practice. We think electrohysterography or automated ultrasound
assessment might be the tool we need to optimally benefit from the knowledge we have of these
uterine contractions and increase pregnancy rates in the future.
Study objective
We think it is possible to measure ans characterize uterine contractions in a non-pregnant uterus, using elektrohysterography (EHG).
Study design
Our goal is to finish Phase I and II in 2017 and Phase III in 2020.
Update 05-10-2018: Phases I, IIa, en IIb are completed. Phases IIIa and IIIb are in progress. We expect
their completion before August 2020.
Intervention
Simultaneous measurements with abdominal electrohysterography and transvaginal ultrasound.
Co-interventions:
In Phase IIa, IIIa and IIIb blood tests are performed to assess hormone levels (estradiol, progesterone,
LH and FSH).
Inclusion criteria
Phase I:
- Age 18-40 years
- Under hormonal fertility treatment
Phase IIa:
- Age ≥18 and premenopausal
- Regular, natural menstrual cycle
Phase IIb:
- Age ≥18 and premenopausal
- Indication for hysterectomy in near future
Phase IIIa:
- Age 18-40
- Regular, natural menstrual cycle
Phase IIIb:
- Age 18-40
- Under hormonal fertility treatment
Exclusion criteria
Phase I:
- Pregnancy
- Mental disability
- Significant language barrier
- Uterine anomalies (congenital or not congenital)
- Uterine pathologies (leiomyomas, adenomyosis, endometriosis)
- Caesarean section in the past
Phase IIa:
- Like in Phase I (Pregnancy, Mental disability, Significant language barrier, Uterine anomalies
(congenital or not congenital), Uterine pathologies (leiomyomas, adenomyosis,
endometriosis), Caesarean section in the past)
- Hormonal medication of any kind
Phase IIb:
- Like in Phase I
Phase IIIa:
- Exclusion criteria of Phase II
- Known infertility
Phase IIIb:
- Exclusion criteria of Phase I
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5035 |
| NTR-old | NTR5264 |
| CCMO | NL52466.100.15 |
| OMON | NL-OMON53115 |