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Secondary Prevention of Morbus Asherman Evaluation of endometrium stimulation with estrogen gestagen post hysteroscopic adhesiolysis

Recruiting
Conditions
M.Asherman uterine synechiae or intrauterine adhesions
10014701
10046828
Registration Number
NL-OMON45234
Lead Sponsor
Spaarne Ziekenhuis
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
110
Inclusion Criteria

Consented patients with M. Asherman who had a successful hysteroscopic adhesiolysis, defined as a restore of the normal uterine cavity, are eligible for inclusion. Patients with M. Asherman should be defined as patients with any diminishing of blood flow (secondary amenorrhoea or secondary hypomenorrhoe) after trauma to the uterine cavity due to pregnancy related surgical procedure with the presence of intrauterine adhesions with a previous history of normal menstrual bloodflow.

Exclusion Criteria

- - Patients with a suspected M. Asherman due to tuberculosis or schitsosomiasis.
- Patients with an uncorrected anovulation, amenorrhoe or oligomenorrhoe previous to the M. Asherman syndrome
- Patients with suspected M. Asherman due to hysteroscopic surgery with the use of electrocoagulation (used in fibroid or polyp surgery)
- Patients with congenital uterine anomalies
- Patients with contraindications for a surgical adhesiolysis
- Patients who do not master the Dutch or English language.
- Patients who are younger than 18 years of age or mentally incompetent.
- Patients with contraindications for estrogen and or gestagen
-Patients who use hormonal suppletion

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>We aim to answer the following primary question:<br /><br>Does exogenous hormone administration (oral administration of estrogen and<br /><br>gestagen) starting immediately after successful hysteroscopic adhesiolysis, in<br /><br>patients with M. Asherman reduces or prevents the incidence and severity (ESGE<br /><br>score/classification) of intra-uterine re-adhesions better then the endogen<br /><br>production of hormones. Presence and extent of adhesions will be evaluated by<br /><br>hysteroscopy 2 months after the initial procedure, using the ESGE<br /><br>classification (Appendix 3.)</p><br>
Secondary Outcome Measures
NameTimeMethod
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