Infertility Clinical Trial
Official title:
A Large Prospective Randomized Trial Comparing Trans-abdominal Ultrasound-guided Embryo Transfer (UGET) With a Novel, Modified Trans-vaginal Ultrasound-guided Embryo Transfer Technique (mTVET) Based on Previous Uterine Length Measurement
Verified date | August 2015 |
Source | University of Turin, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
One thousand, six hundred forty-eight IVF patients undergoing ET with fresh embryos, randomized to receive mTVET (n=828) or UGET (n=820). The transfer in uteri of 1-2 embryos on day 2-3 of culture was performed using a soft catheter either under trans-abdominal US guidance (UGET group) or after measurement of uterine cavity by transvaginal US and calculation of the discharge site (mTVET). Mai outcome measures was the clinical pregnancy rate (CPR), secondary outcomes were the implantation rate (IR), and the patient's discomfort during ET procedure.
Status | Completed |
Enrollment | 1648 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 43 Years |
Eligibility |
Inclusion Criteria: - patients undergoing autologous IVF - ending IVF cycle with the transfer of fresh embryos - treated at the investigators'r IVF Unit between Jan 2012 to Dec 2014 Exclusion Criteria: - patients undergoing donor IVF - ending IVF cycle without embryo transfer - transferring frozen-thawed embryos - treated elsewhere |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Physiopathology of Reproduction and IVF Unit, S. Anna Hospital | Torino |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical pregnancy rate per embryo transfer (CPR/ET) | 3 years | No | |
Primary | implantation rate | 3 weeks (until the pregnancy test is performed) | No | |
Secondary | proportion of patients feeling moderate-to-severe discomfort during ET | 3 years | No |
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