Use of Adiana Tubal Occlusive Devices in Women With Hydrosalpinx Prior to In Vitro Fertilization (NCT01224080) | Clinical Trial Compass
UnknownPhase 2
Use of Adiana Tubal Occlusive Devices in Women With Hydrosalpinx Prior to In Vitro Fertilization
United States10 participantsStarted 2010-10
Plain-language summary
A condition called hydrosalpinx occurs when one or both of the fallopian tubes is blocked with fluid. The fluid can leak into the tube and the uterus. The theory is that the fluid can harm the tubes and uterus making implantation more difficult or harm the embryo.
Who can participate
Age range21 Years – 43 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Are willing to participate in this clinical study
* Are able to comprehend and give informed consent for participation in this study
* Have read, understood and signed an informed consent form
* Have been unable to achieve pregnancy after trying for 1 year or greater and who have unilateral or bilateral hydrosalpinges as evidenced by laparoscopy or ultrasound or HSG
* Have a Day #3 serum FSH\<10, and Day #3 Estradiol\<80
* Recipient women undergoing a ovum donor cycle the donor must have a Day 3 serum FSH \< 10 and Day 3 Estradiol \< 80
* Have an antral follicle count 10 or greater for both ovaries combined, if women using ovum donor (follicle count) will be based on eligible donor
* Have a desire to receive treatment for their HS
* Are willing to undergo a hysterosalpingogram (HSG) 3 months after ADIANA placement to confirm proximal tubal occlusion
Exclusion Criteria:
* Active or recent upper or lower pelvic infection
* Known hypersensitivity to nickel as confirmed by skin test
* Known allergy to contrast media
* Pregnancy or suspected pregnancy
* Delivery or termination of pregnancy less than six weeks prior to Adiana placements
* BMI \> 35
* Abnormal pap smear (CIN2 or greater abnormality) within the past year
* Pelvic malignancy
* Severely retroverted uterus
* Evidence of intrauterine abnormalities such as submucous fibroids, polyps, intrauterine adhesions or presence of a uterine septum
* Abnormal Clomid Challenge Test or abnormal lab values on D…
What they're measuring
1
Evaluate the success rate of proximal tubal occlusion with Adiana inserts in women with hydrosalpinx