Status:
UNKNOWN
Use of Adiana Tubal Occlusive Devices in Women With Hydrosalpinx Prior to In Vitro Fertilization
Lead Sponsor:
Reproductive Science Center
Conditions:
Women Suffering From Unilateral or Bilateral Tubal Occlusion Due to Hydrosalpinx
Eligibility:
FEMALE
21-43 years
Phase:
PHASE2
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01224080
Start Date
October 1 2010
Last Update
October 19 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Reproductive Science Center
San Ramon, California, United States, 94583