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WAVES studie


- candidate number22385
- NTR NumberNTR5264
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-jun-2015
- Secondary IDsNL52466.100.15 
- Public TitleWAVES studie
- Scientific TitleEndometrial peristalsis and fertility
- ACRONYM
- hypothesisWe think it is possible to measure ans characterize uterine contractions in a non-pregnant uterus, using elektrohysterography (EHG).
- Healt Condition(s) or Problem(s) studiedSubfertility, IVF, ART
- Inclusion criteriaPhase I:
- Age 18-40 years
- Under hormonal fertility treatment

Phase II:
- Age 18-40 years
- Regular, natural menstrual cycle

Phase IIIa:
- Age 18-40
- Regular, natural menstrual cycle

Phase IIIb:
- Age 18-40
- Under hormonal fertility treatment

- Exclusion criteriaPhase I:
- Pregnancy
- Mental disability
- Significant language barrier
- Uterine anomalies (congenital or not congenital)
- Uterine pathologies (leiomyomas, adenomyosis, endometriosis)
- Caesarean section in the past

Phase II:
- Exclusion criteria of Phase I
- Hormonal medication of any kind

Phase IIIa:
- Exclusion criteria of Phase II
- Known infertility

Phase IIIb:
- Exclusion criteria of Phase I
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 3-aug-2015
- planned closingdate3-aug-2020
- Target number of participants135
- InterventionsMeasuring elektrical activity of the uterine muscle using abdominal EHG.

Co- interventions:
To validate the results of the abdominal EHG we perform transvaginal ultrasound, transvaginal EHG and, in a selected group of patients, intrauterine EHG. Because of the influence of hormones on contractions, bloodlevels of progesteron, oestradiol, FSH and LH are checked with every measurement.
- Primary outcome1. Test reliability of the EHG in measuring 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 outcome1. 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.
- TimepointsOur goal is to finish Phase I and II in 2017 and Phase III in 2020.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES N.P.M. Kuijsters
- CONTACT for SCIENTIFIC QUERIES N.P.M. Kuijsters
- Sponsor/Initiator Catharina Hospital Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
HTSM Grant
- Publications
- Brief summarySuccessful 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.
- Main changes (audit trail)7-okt-2018 -IK:

INCLUSION CRITERIA:
"Phase II:
- Age 18-40 years
- Regular, natural menstrual cycle"

replaced by

"Phase IIa:
- Age ≥18 and premenopausal
- Regular, natural menstrual cycle
Phase IIb:
- Age ≥18 and premenopausal
- Indication for hysterectomy in near future"


EXCLUSION CRITERIA:
"Phase II:
- Exclusion criteria of Phase I
- Hormonal medication of any kind"

replaced by

"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"


TARGET NUMBER OF PARTICIPANTS:
Phase I: 10
Phase IIa: 10
Phase IIb: 20
Phase IIIa: 35
Phase IIIb: 60
Total = 135


INTERVENTIONS:
"Measuring elektrical activity of the uterine muscle using abdominal EHG.
Co- interventions:
To validate the results of the abdominal EHG we perform transvaginal ultrasound, transvaginal EHG and, in a selected group of patients, intrauterine EHG. Because of the influence of hormones on contractions, bloodlevels of progesteron, oestradiol, FSH and LH are checked with every measurement."

replaced by

"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)."


PRIMARY OUTCOME:
"1. Test reliability of the EHG in measuring 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)."

replaced by

"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 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."

replaced by

"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."


TIMEPOINTS:
"Our goal is to finish Phase I and II in 2017 and Phase III in 2020."

replaced by

"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."
- RECORD25-jun-2015 - 7-okt-2018


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