No registrations found.
ID
Source
Brief title
Health condition
Asherman Syndrome
Sponsors and support
Intervention
Outcome measures
Primary outcome
Spontaneous recurrence of intra uterine adhesion
Secondary outcome
• Ongoing pregnancy (in those patients willingly to conceive) after one year follow-up. During a follow up of 1 year the number and time to conceive will be recorded. The clinical as well as the ongoing pregnancies (defined as intra-uterine heart activity at 12 weeks gestation)
• The number of performed re-interventions (hysteroscopic adhesiolysis in the OR or outpatient clinic or adhesiolysis without hysteroscopy (dilatation) in outpatient clinic setting)
• Complication related to postoperative estrogen and gestagen administration or any side-effect.
. Long term follow-up over 10 years, re-interventions, fertility outcome, pregnancy outcome, obstetrical outcome and chronicle pelvic pain
Background summary
Evaluation of exogenous hormone administration (oral administration of estrogen and gestagen) starting immediately after successful hysteroscopic adhesiolysis, in patients with Asherman Syndrome (As) reduces or prevents the incidence and severity (ESGE score/classification) of spontaneous re-adhesions better then the endogen production of hormones. Secondly to evaluate the long term outcome of fertility, pregnancy and obstetrical outcome and chronical pelvic pain
Study objective
The hypothesis is that exogenous hormone administration (oral administration of estrogen and gestagen) starting immediately after successful hysteroscopic adhesiolysis, in patients with Asherman Syndrome reduces or prevents the incidence and severity (ESGE score/classification) of spontaneous recurrence of adhesion better then the endogen production of hormones.
Study design
1 year, 3 years, 10 years
Intervention
exogenous hormone administration (oral administration of estrogen and gestagen) starting immediately after successful hysteroscopic adhesiolysis
Inclusion criteria
Consented patients with Asherman Syndrome (AS) who had a successful hysteroscopic adhesiolysis, defined as a restore of the normal uterine cavity, were eligible for inclusion. Patients with AS 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 blood flow.
Exclusion criteria
- Patients with a suspected AS due to tuberculosis or schitsosomiasis.
- Patients with an uncorrected anovulation, amenorrhoe or oligomenorrhoe previous to the AS
- Patients with suspected AS 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9655 |
| CCMO | NL41190.094.13 |
| OMON | NL-OMON45234 |