Endometrial Injury and IVF Outcome Parameters in Patients With Failed IVF Cycles
Phase 2
Completed
- Conditions
- Repeated Implantation Failures
- Registration Number
- NCT01798862
- Lead Sponsor
- National and Kapodistrian University of Athens
- Brief Summary
The iatrogenic induction of local endometrial injury caused through hysteroscopy or pipelle sampling in the preceding non- transfer cycle improves the IVF outcome parameters in patients with previous IVF failures.
- Detailed Description
Endometrial injury was preformed either through hysteroscope during office hysteroscopy through the non touch technique or through pipelle biopsy in the early follicular phase (days 5 to 9) in the preceding cycle of the IVF treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
Inclusion Criteria
- Personal history of 2 or more failed IVF/ICSI cycles (RIF)
- Age</= 42 years
- Good response with good quality embryos in previous attempts (>2)
Exclusion Criteria
- Personal history of endometrial tuberculosis/ antituberculous treatment
- Sonographically detected hydrosalpinges
- Intramural fibroids distorting the endometrial cavity, submucous myomas or Asherman's syndrome
- Thrombophilia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method positive bHCG rate through study completion, an average of 2 years
- Secondary Outcome Measures
Name Time Method clinical pregnancy rate 2 years Pregnancy complications (preterm birth, placental abnormalities, bleeding throughout pregnancy, pregnancy related hypertensive disorders, IUGR and SGA) 2 years Ectopic pregnancy rate 2 years Miscarriage rate 2 years Ongoing pregnancy rate 2 years live birth rate 2 years
Trial Locations
- Locations (2)
Assisted Reproduction Unit 3rd Department of Obstetrics & Gynecology, Attikon University Hospital
🇬🇷Athens, Attica, Greece
Assisted Reproduction Unit
🇬🇷Alexandroupolis, Thrace, Greece
Assisted Reproduction Unit 3rd Department of Obstetrics & Gynecology, Attikon University Hospital🇬🇷Athens, Attica, Greece