We think it is possible to measure ans characterize uterine contractions in a non-pregnant uterus, using elektrohysterography (EHG).
ID
Bron
Aandoening
Subfertility, IVF, ART, uterine contractions
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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).
Achtergrond van het onderzoek
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.
Doel van het onderzoek
We think it is possible to measure ans characterize uterine contractions in a non-pregnant uterus, using elektrohysterography (EHG).
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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).
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5035 |
| NTR-old | NTR5264 |
| CCMO | NL52466.100.15 |
| OMON | NL-OMON53115 |