Use of Adiana Tubal Occlusive Devices in Women With Hydrosalpinx Prior to In Vitro Fertilization

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 Day #3 serum FSH and
Estradiol

- Antral follicle count less than 10 (both ovaries combined)

- Poor general or gynecologic health

- Inability or refusal to provide informed consent