WAVES studie
- Conditions
- Subfertility, IVF, ART, uterine contractions
- Registration Number
- NL-OMON29437
- Lead Sponsor
- Catharina Ziekenhuis, Eindhoven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 135
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
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Test reliability of electrohysterographic and automated ultrasound for assessing uterine<br>contractions during different phases of the normal menstrual cycle in a prospective selected cohort.<br>2. Determine objective changes in electric activity and subsequent endometrial wave patterns in<br>relation to phase of menstrual cycle (characterization of waves).
- Secondary Outcome Measures
Name Time Method 1. Identification of prognostic features of electrohysterographic and automated ultrasound for the<br>success rate of fertility treatment.<br>2. Identifying the role of sex-hormone blood levels in the characteristics of endometrial waves.