We want to stuudy if exogenous hormone administration (oral administration of estrogen and gestagen) starting immediately after successful hysteroscopic adhesiolysis, in patients with M. Asherman reduces or prevents the incidence and severity (ESGE…
ID
Source
Brief title
Condition
- Endocrine disorders of gonadal function
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We aim to answer the following primary question:
Does exogenous hormone administration (oral administration of estrogen and
gestagen) starting immediately after successful hysteroscopic adhesiolysis, in
patients with M. Asherman reduces or prevents the incidence and severity (ESGE
score/classification) of intra-uterine re-adhesions better then the endogen
production of hormones. Presence and extent of adhesions will be evaluated by
hysteroscopy 2 months after the initial procedure, using the ESGE
classification (Appendix 3.)
Secondary outcome
We aim to answer the following secondary questions:
1. Does secondary prevention of M. Asherman with hormonal support post
operative adhesiolysis restore the normal menstrual bloodflow on shorter
(2months) and longterm (6 and 9months) assessed with a *Pictorial Blood Loss
Assement* (PBAC) (Appendix II).
2. Does secondary prevention of M. Asherman with hormonal support post
operative adhesiolysis increase the pregnancy rate. This the hazzard ratio for
any 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) and the course of the
pregnancies will be recorded.
3. The number of performed re-interventions (hysteroscopic
adhesiolysis in the OR or outpatient clinic or adhesiolysis without
hysteroscopy (dilatation) in outpatient clinic setting) during one year per
patient will be closely monitored and recorded.
4. Complication related to postoperative estrogen and gestagen administration
or any side-effec
Background summary
The prevalence of M. Asherman varies widely depending on the trauma caused to
the uterus. The true incidence of this condition is difficult to determine,
ranging from 1.5% of patients referred for fertility testing up to 40% of
women following secondary removal of placental tissue or repeat curettage after
a missed abortion. There is almost universal support that surgical treatment is
the criterion standard in management of Asherman syndrome, and there is no role
for medical treatments. There is no consensus as to the optimal technique of
division of adhesions. The most used technique is according to the methods
described by Broome and Vancaillie in 1999 .
There is a lack of prospective randomized controlled trials on the secondary
prevention of Asherman syndrome. Insertion of an IUD provides a physical
barrier between the uterine walls, separating the endometrial layers after
lysis of intrauterine adhesions the effectivesness has been studied in one
study from 1982 . The addition of medication in period after the surgical
restore is poorly investigated. In 1964, Wood and Pena described estrogen
therapy to stimulate regeneration of the endometrium and promote
reepithelization of the endometrium after surgical treatment of intrauterine
adhesions. Various regimens have been described for postoperative treatment
with estrogens (e.g., a daily dose of 2.5 mg of conjugated equine estrogen)
with or without opposing progesterone for 2 to 3 cycles. No comparative studies
have been performed on effectiveness, dosage, administration, or combination of
hormones in pateintes with m. Asherman. The question is wheather endometrium
stimulations with exogene substitution of oestogen en progesterone is a better
prevention of secondary adhesiolysis after succesvol hysteroscopic adhesiolysis
in patients with M. Asherman than the endogene production of hormones,
Study objective
We want to stuudy if exogenous hormone administration (oral administration of
estrogen and gestagen) starting immediately after successful hysteroscopic
adhesiolysis, in patients with M. Asherman reduces or prevents the incidence
and severity (ESGE score/classification) of intra-uterine re-adhesions better
then the endogen production of hormones.
Study design
Singlecentre randomized controlled trial.
Intervention
Consented patients undergoing hysteroscopic adhesiolysis will be randomly
allocated to receive secondary prevention of M. Asherman with exogene hormonal
support to stimulate the endometrium post operative adhesiolysis (intervention)
group or surgery alone (control) group.
Study burden and risks
Nature and extent of the burden
The patients who are treated at the Spaarne hospital for M. Asherman at this
moment, who had a succesfull adhesiolysis receive a IUD and hormone secudule
post operative. After 3 months they get an appointment for an office
hysteroscopy. The extra burden will be completing teh CRf and questionairs at
2,6-9 and 12 months.
Spaarnepoort 1
Hoofddorp 2130 AT
NL
Spaarnepoort 1
Hoofddorp 2130 AT
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL41190.094.13 |
OMON | NL-OMON24510 |