Endometrial Waves and Fertility and Benign Uterine Disorders

Recruiting

Conditions: Uterine contractions
uterine peristalsis
10013356

Registration Number: NL-OMON53115

Lead Sponsor: Catharina-ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 240

Inclusion Criteria

- Phase I: Age 18-40 years, patients under hormonal fertility treatment
- Phase IIa: Age 18-40 years, healthy women with regular natural cycle.
- Phase IIb: Age >18 years, hysterectomy
- Phase IIc: Age 18-40 years, diagnosed with at least one of the following:
adenomyosis, leiomyoma, uterine anomaly
- Optional: under hormonal fertility treatment in the context of IVF
- Phase III:
- Age 18-40 years
- Regular menstrual cycle
- Diagnosed with at least one of the following: adenomyosis, leiomyoma,
(congenital) uterine anomaly, placental remnant AND/OR:
- Wish for intrauterine contraceptive device
- Under hormonal fertility treatment in the context of IVF

Exclusion Criteria

General:
- Pregnancy
- Mental disability
- Significant language barrier
Phase Ia:
- Uterine anomalies (congenital or not congenital)
- Uterine pathologies (leiomyomas, adenomyosis, endometriosis)
- Cesarian section in the past, Phase IIa:
- Exclusion criteria of Phase I
- Hormonal medication of any kind,
Phase IIb:
- General + Phase I
- Phase IIc, III: General exclusion criteria

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. reliability of the EHG during different phases of the normal menstrual cycle<br /><br>in a prospective selected cohort<br /><br>2. Determine objective changes in electric activity and subsequent endometrial<br /><br>wave patterns in relation to phase of menstrual cycle (characterization of<br /><br>waves).<br /><br>3. Assess the influence of the vaginal microbiome on uterine peristalsis in<br /><br>infertile and fertile women<br /><br><br /><br>Outcomes Phase IIc:<br /><br>- Uterine contraction parameters (frequency, amplitude, coordination,<br /><br>direction) pre and post hormonal therapy, and/or prior to embryo transfer<br /><br><br /><br>Outcomes Phase III:<br /><br>- Uterine contraction parameters (frequency, amplitude, coordination,<br /><br>direction) prior to placement/removal of IUDs or placental remnants<br /><br></p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Identification of prognostic factors for fertility in relation to changes in<br /><br>electric myometrial during the menstrual cycle.<br /><br>2. Identifying the role of sex-hormone bloodlevels in the characteristics of<br /><br>endometrial waves.</p><br>