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WAVES studie

Endometrial peristalsis and fertility

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON29437
Enrollment
135
Registered
2015-06-25
Start date
2015-08-03
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subfertility, IVF, ART, uterine contractions

Interventions

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,

Sponsors

Catharina Ziekenhuis, Eindhoven
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Contacts

Public ContactN.P.M. Kuijsters

-

nienkekuijsters@live.nl-

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)