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| ID | Type | Description | Link |
|---|---|---|---|
| 2016/1235 | Other Identifier | Ghent University Hospital |
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Due to the slow recruitment of patients
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This is a two-arm parallel group randomized controlled trial at the Department of Reproductive Medicine at Ghent University Hospital. Women >=18 and <37 years of age undergoing their first or second IVF/ICSI treatment, with at least 2 good quality blastocysts remaining after fresh embryo transfer will be randomized to either transfer of a cryopreserved blastocyst selected based on morphology (standard treatment arm) or transfer of a cryopreserved blastocyst selected based on PGS and morphology (intervention treatment arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PGS (genetic screening) | Experimental | Intent to transfer single cryopreserved embryo, selection based on euploid status (after preimplantation genetic screening) and standard morphological assessment |
|
| no PGS (no genetic screening) | No Intervention | Intent to transfer single cryopreserved embryo, selection based on standard morphological assessment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preimplantation Genetic Screening | Diagnostic Test |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy | Rate of clinical pregnancy (a pregnancy diagnosed by ultrasonic visualisation of one or more gestational sacs with fetal heart beat) after transfer of embryo in PGS arm versus in no PGS arm. | At 7 - 8 gestational weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical pregnancy | Rate of biochemical pregnancy (a pregnancy diagnosed only by either serum or urine β-hCG, and the serial results decrease to negative; no ultrasonic visualisation of one or more gestational sacs) after transfer of embryo in PGS arm versus in no PGS arm. | At 7 -8 gestational weeks |
| Clinical miscarriage |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Petra De Sutter, M.D; PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital - Department of Reproductive Medicine | Ghent | 9000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32898291 | Derived | Cornelisse S, Zagers M, Kostova E, Fleischer K, van Wely M, Mastenbroek S. Preimplantation genetic testing for aneuploidies (abnormal number of chromosomes) in in vitro fertilisation. Cochrane Database Syst Rev. 2020 Sep 8;9(9):CD005291. doi: 10.1002/14651858.CD005291.pub3. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D019836 | Preimplantation Diagnosis |
| ID | Term |
|---|---|
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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RCT (randomized controlled trial)
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Rate of clinical miscarriage (intrauterine pregnancy demise confirmed by ultrasound or histology) after transfer of embryo in PGS arm versus in no PGS arm. |
| At 7 - 16 gestational weeks |
| Live birth | Rate of live birth (> 24 weeks gestation) after transfer of embryo in PGS arm versus in no PGS arm. | At delivery |
| Aneuploidy | Rate of aneuploid versus rate of euploid embryos in PGS arm. | At delivery |