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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | Patients underwent hysteroscopy examination before IVF cycle. |
|
| Group II | No Intervention | Patients underwent direct IVF cycle without previous hysteroscopy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hysteroscopy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment | Percentage of biochemical, clinical, on-going pregnancy and livebirth of IVF treatment comparing both groups. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of endocervical canal and uterine cavity pathology and the impact of treatment of these pathologies. | Percentage of endocervical canal and uterine cavity pathology and the impact of treatment of these pathologies in the rate of pregnancy and livebirth. | 12 months |
| Rate of hysteroscopy tolerance |
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Inclusion Criteria:
Exclusion Criteria:
Patients included in the study must be female with uterus.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Paz University Hospital | Madrid | 28046 | Spain |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015907 | Hysteroscopy |
| ID | Term |
|---|---|
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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Randomized open-label clinical 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.
The second group (group II): 37 patients underwent direct cycle without previous hysteroscopy.
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The tolerance of the procedure was evaluate in the patients randomized to the group I of the study. |
| 1 month. |
| Hysteroscopy complication rate. | We evaluate the complication of the hysteroscopy during and after the procedure. Includes blooding, infections, uterine perforation, etc. | 2 months |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |