To evaluate the effect of uterine bathing in improving the results of IVF/ICSI treatment in patients with endometriosis ASRM stage I-IV.
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Live birth rate after fresh embryo transfer.
Secondary outcome
Implantation rate, clinical pregnancy rate, ongoing pregnancy rate,
miscarriages rate, ectopic pregnancy rate, multiple pregnancy rate.
Background summary
In patients with endometriosis, IVF/ICSI ongoing pregnancy rates are decreased
compared to patients without endometriosis. This could be the result of an
impaired implantation due to an immunological altered endometrium. In
endometriosis patients, uterine bathing with Lipiodol seems to improve IVF/ICSI
pregnancy rates. The mechanism of this observed improvement is still unclear,
but could be related to the mechanical pressure on the endometrium induced by
intrauterine infusion of fluids. More invasively, local endometrial injury is
shown to positively influence ongoing pregnancy rates in patients with
recurrent implantation failure undergoing IVF/ICSI. This is probably based on
the provocation of an inflammatory reaction, which stimulates endometrial
regeneration and proliferation, which is necessary for successful implantation.
To a lesser extent this might be induced by mechanical stress, which is a less
invasive procedure than local endometrial injury. However, this has not been
investigated yet in endometriosis patients.
Study objective
To evaluate the effect of uterine bathing in improving the results of IVF/ICSI
treatment in patients with endometriosis ASRM stage I-IV.
Study design
Prospective randomized controlled pilot trial, parallel, two-arm study.
Intervention
Patients will be randomized to undergo uterine bathing through a GIS
(intervention group) or a sham procedure (control group) before treatment with
IVF/ICSI. The intervention will be performed in the *follicular phase* just
before starting the GnRH analogue treatment (between the end of menses and
cycle day 12).
Study burden and risks
A Gel Infusion Sonography (GIS) is routinely performed in patients during the
fertility work up to rule out intracavitary pathology. During GIS some women
experience minor discomfort in their lower abdomen. Furthermore bacteria in the
vagina may enter the uterine cavity during GIS. This rarely happens, but if
some bacteria enter the uterine cavity, this seldom leads to an intrauterine
infection. Following a GIS procedure some patients will have light vaginal
bleeding, which will cease within one or two days. All possible side effects
and severe adverse events will be monitored and evaluated. The intervention
will be performed at a routine visit, so there will be no more visits during
participation. Since randomization is performed every participant has an equal
chance to profit from possible benefits.
De Boelelaan 1118
Amsterdam 1081 HZ
NL
De Boelelaan 1118
Amsterdam 1081 HZ
NL
Listed location countries
Age
Inclusion criteria
- Woman between 18 and 41 years old.
- Indication for IVF/ICSI (first, second or third attempt)
- Endometriosis ASRM stage I-IV
- Signed informed consent.
Exclusion criteria
- Women aged over 41 years
- Women who are unable to undergo IVF/ICSI
- Uterusanomalies (bicornis/didelphys/septa)
- Pregnancy
- Malignancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46661.029.13 |