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Essure® intratubal device placement for Hydrosalpinx in patients undrgoing IVF treatment. A randomized comparison with laparoscopic removal of the hydrosalpinx.


- candidate number6628
- NTR NumberNTR2073
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-okt-2009
- Secondary IDs2008-337 METC Vumc Amsterdam
- Public TitleEssure® intratubal device placement for Hydrosalpinx in patients undrgoing IVF treatment. A randomized comparison with laparoscopic removal of the hydrosalpinx.
- Scientific TitleProspective randomized trial to evaluate and to compare the impact of hysteroscopic and laparoscopic salpingectomy on IVF-ET outcomes of patients with hydrosalpinx.
- ACRONYMDutch Essure® versus Salpingectomy for Hydrosalpinx
- hypothesisThe hypothesis of this study is that hysteroscopic treatment of hydrosalpinges with essure devices is as effective as laparoscopic salpingectomy with respect to subsequent IVF-ET outcomes but is related to less burden (in contrast to laparoscopic treatment, hysteroscopic treatment can be performed in an outpatient setting, without use of general anaesthesia, with shorter procedure times and a quicker recovery) and possibly also less interventional and/or anaesthesiologic risk for the patient.
- Healt Condition(s) or Problem(s) studiedIn vitro fertilization (IVF), Laparoscopy, Salpinectomy
- Inclusion criteria1. Presence of uni- or bilateral hydrosalpinges prior to IVF-ET. A hydrosalpinx is defined as: a distally occluded fallopian tube which was pathologically dilated or became pathologically dilated when patency was tested by hysterosalpingography and/or laparoscopy. The hydrosalpinx should be visible on ultrasound performed midcyclically as these have been associated with the poorest prognosis regarding IVF-ET outcomes [5];
2. Female age ¡Ü 40 years at the time of randomization;
3. Patient suitable for IVF-ET treatment;
4. Patient suitable for laparoscopic surgery;
5. Concomitant male factor requiring intracytoplasmatic sperm injection (ICSI) is accepted provided that a centre has an established ICSI programme with results equivalent to conventional IVF.
- Exclusion criteria1. Female age > 40 years at the time of randomization;
2. Pregnancy or suspected pregnancy;
3. Recent or active pelvic infection;
4. Previous tubal ligation;
5. Evidence of proximal tubal occlusion in the hydrosalpinx seen at HSG or at laparoscopy;
6. Patient not suitable for IVF-ET;
7. Patient not suitable for laparoscopic surgery;
8. Concomitant male factor not suitable for ICSI;
9. Uterine fibroids interfering with IVF-ET, ICSI or placement of Essure ® devices;
10. Presence of any malignancy.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 24-sep-2009
- planned closingdate24-sep-2011
- Target number of participants80
- InterventionsEssure® intratubal device placement (new treatment) and laparoscopic salpingectomy (standard treatment) on IVF-ET outcomes of patients with hydrosalpinx.
- Primary outcomeClinical pregnancy rate (defined by the demonstration of fetal heart activity on ultrasound).
- Secondary outcome1. Success rate of proximal tubal occlusion with Essure® devices (demonstrated by HSG);
2. Miscarriage rate;
3. Implantation rate (defined as number of gestational sacs on ultrasound/ number of embryo¡¯s transferred);
4. Ectopic pregnancy rate;
5. Multiple pregnancy rate;
6. Complications rate;
7. Ovarian reserve pre- vs. postsurgery (determined by early follicular serum FSH/AMH as well as antral follicle counts).
- Timepoints1. Baseline;
2. 3 months;
3. After first IVF.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESdr. V. Mijatovic
- CONTACT for SCIENTIFIC QUERIESdr. V. Mijatovic
- Sponsor/Initiator VU University Medical Center, Department of Reproductive medicine
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center, Department of Obstetrics and Gynaecology
- PublicationsN/A
- Brief summaryThe primary objective is to evaluate and compare the impact of hysteroscopic Essure® intratubal device placement (new treatment) and laparoscopic salpingectomy (standard treatment) on IVF-ET outcomes of patients with hydrosalpinx.

Laparoscopic salpingectomy for hydrosalpinx may compromise ovarian reserve in women undergoing IVF-ET by partly disrupting the blood flow to the ovary. Therefore, our secondary objective is to evaluate ovarian reserve through measurements of early follicular phase serum FSH & AMH levels as well as antral follicle counts (transvaginal ultrasound) presurgery and 3 months postsurgery in both study groups.
- Main changes (audit trail)
- RECORD21-okt-2009 - 4-nov-2009


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