La Paz University Hospital
Madrid, 28046, Spain
NCT Number: NCT03173404
This is a prospective randomized open-label trial. Women scheduled for their first or second in-vitro fertilization/intracytoplasmatic Sperm Injection (IVF/ICSI) cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. In the first group (group I) 31 patients underwent hysteroscopy examination before IVF cycle while in the second group (group II) 37 patients underwent direct cycle without previous hysteroscopy
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Notify Me18 year–40 year
Female
Interventional
Not applicable
Madrid, 28046, Spain
This is a prospective randomized open-label trial. Women scheduled for their first or second IVF/ICSI cycle and with no abnormality detected in transvaginal ultrasound examination, were randomized to two groups. In the first group (group I) 31 patients underwent hysteroscopy examination before IVF cycle while in the second group (group II) 37 patients underwent direct cycle without previous hysteroscopy. Then IVF cycle was performed with habitual protocol. Beta Corionic Gonatropic hormone (BhCG) test two weeks after embryo transfer was done. If test was positive, patients were followed up for detection pregnancy by transvaginal ultrasound two weeks later. Another transvaginal ultrasound at 12 weeks of gestation was done to confirm ongoing pregnancy. Biochemical pregnancy, implantation, on-going pregnancy and livebirth rates were compared in both groups.
Miscarriage, complications rate and hysteroscopy tolerability were also analyzed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The hysteroscopy is the visualization of the cervical canal and uterine cavity with a camera. Patients randomized to group I underwent hysteroscopy prior to the IVF cycle.
Time frame: 12 months
Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment comparing both groups.
Time frame: 12 months
Percentage of endocervical canal and uterine cavity pathology and the impact of treatment of these pathologies in the rate of pregnancy and livebirth.
Time frame: 1 month.
The tolerance of the procedure was evaluate in the patients randomized to the group I of the study.
Time frame: 2 months
We evaluate the complication of the hysteroscopy during and after the procedure. Includes blooding, infections, uterine perforation, etc.
Instituto de Investigación Hospital Universitario La Paz
Other
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