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The effect of uterine bathing on implantation in endometriosis patients undergoing IVF/ICSI: a randomized controlled pilot trial


- candidate number15510
- NTR NumberNTR4198
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-okt-2013
- Secondary IDs2013.424 METc VUmc
- Public TitleThe effect of uterine bathing on implantation in endometriosis patients undergoing IVF/ICSI: a randomized controlled pilot trial
- Scientific TitleThe effect of uterine bathing on implantation in endometriosis patients undergoing IVF/ICSI: a randomized controlled pilot trial
- ACRONYMTUBIE trial
- hypothesisThe primary hypothesis is that mechanical stress on the endometrium, induced by uterine bathing, results in higher live birth rates after IVF/ICSI treatment in patients with endometriosis (ASRM stage I-IV), compared to a placebo procedure.
- Healt Condition(s) or Problem(s) studiedSubfertility, IVF, Implementation, Endometriosis
- Inclusion criteria1. Age between 18 and 41 years old
2. Undergoing a IVF/ICSI treatment
3. Minimal to mild endometriosis
- Exclusion criteria1. Women aged over 41 years
2. Women who are unable to undergo IVF/ICSI
3. Uterus anomalies (bicornis/didelphys/septa)
4. If not willing or able to sign the consent form.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate1-jan-2019
- Target number of participants184
- Interventions 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 GIS will be performed by our local protocol. During the intervention a flexible catheter is placed beyond the ostium internum and will be connected to a syringe with approximately 10cc Gel, which will be infused in the uterine cavity. A transvaginal ultrasound will be made to check uterine distension. The Sham procedure is exactly performed like the GIS, with the exception of cervical insertion of the catheter. The catheter will be placed intravaginally. 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). After the procedure IVF/ICSI treatment will be continued according to our local protocol. Live birth rate after the first fresh embryo transfer will be our primary outcome. If patients are pregnant, after 9 months a questionnaire will be send to collect the data.
- Primary outcomeOngoing pregnancy rate after fresh embryo transfer
- Secondary outcomeImplantation rate – Positive pregnancy test two weeks after fresh embryo transfer.
Clinical pregnancy rate – Ultrasound visible gestational sac with or without heartbeat.
Live birth rate – Questionnaire 9 months after embryo transfer.
- TimepointsOngoing pregnancy rate after fresh embryo (primary outcome): Vital intrauterine pregnancy 12 weeks after embryo transfer,
- Trial web site-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMsc Marit Lier
- CONTACT for SCIENTIFIC QUERIESMsc Marit Lier
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryIn 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. The purpose of this randomized controlled pilot study is to evaluate the effect of uterine bathing in improving the results of IVF/ICSI treatment in patients with endometriosis ASRM stage I-IV.
- Main changes (audit trail)11-apr-2014: METc approval - AB 12-apr-2017: Changes:
Inclusion criteria:
1. Age between 18 and 41 years old
2. Undergoing IVF/ICSI treatment
3. Endometriosis ASRM stage I-IV

Exclusion criteria:
1. Women aged over 41 years
2. Women who are unable to undergo IVF/ICSI treatment
3. Uterus anomalies (bicornis/didelphys/septa)
4. Pregnancy or malignancy
5. Not willing or able to sign the consent form
6. Previous participation in the trial

Interventions: 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 GIS will be performed by our local protocol. During the intervention a flexible catheter is placed beyond the ostium internum and will be connected to a syringe with approximately 10cc Gel, which will be infused in the uterine cavity. A transvaginal ultrasound will be made to check uterine distension. The Sham procedure is exactly performed like the GIS, with the exception of cervical insertion of the catheter. The catheter will be placed intravaginal. The intervention will be performed in the ‘luteal phase’ of the cycle preceding the IVF/ICSI treatment, on the same day the GnRH analogue treatment is started. After the procedure IVF/ICSI treatment will be continued according to our local protocol. Live birth rate after the first fresh embryo transfer will be our primary outcome. If patients are pregnant, after 9 months a questionnaire will be send to collect the data.

Primary outcome: Live birth rate after fresh embryo transfer

Secondary outcomes: - Implantation rate, clinical pregnancy rate, ongoing pregnancy rate after fresh embryo transfer. - Multiple pregnancy, miscarriage and ectopic pregnancy rate after fresh embryo transfer. - Endometrial thickness at the day of Pregnyl®. - Adverse events defined as: intrauterine infection and severe bleeding after the intervention.

Timepoints: - Ongoing pregnancy rate after fresh embryo (secondary outcome): Vital intrauterine pregnancy 12 weeks after embryo transfer. – Live birth rate after fresh embryo transfer (primary outcome): Live birth 9 months after embryo transfer (questionnaire).

- RECORD7-okt-2013 - 12-apr-2017


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