Essure® intratubal device placement for Hydrosalpinx in patients undrgoing IVF treatment. A randomized comparison with laparoscopic removal of the hydrosalpinx.
Recruiting
- Conditions
- Hydrosalpinx, IVF, Essure, Laparoscopy, salpingectomy
- Registration Number
- NL-OMON24394
- Lead Sponsor
- VUmc, afdeling Voortplantingsgeneeskunde.
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
1. 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;
Exclusion Criteria
1. Female age > 40 years at the time of randomization;
2. Pregnancy or suspected pregnancy;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical pregnancy rate (defined by the demonstration of fetal heart activity on ultrasound).
- Secondary Outcome Measures
Name Time Method 1. Success rate of proximal tubal occlusion with Essure® devices (demonstrated by HSG);<br /><br>2. Miscarriage rate;<br /><br>3. Implantation rate (defined as number of gestational sacs on ultrasound/ number of embryo¡¯s transferred);<br /><br>4. Ectopic pregnancy rate;<br /><br>5. Multiple pregnancy rate;<br /><br>6. Complications rate;<br /><br>7. Ovarian reserve pre- vs. postsurgery (determined by early follicular serum FSH/AMH as well as antral follicle counts).<br>