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| Name | Class |
|---|---|
| Onze Lieve Vrouw Hospital | OTHER |
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The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hCG | Active Comparator | 5000 IU Pregnyl SC |
|
| hCG and GnRH agonist | Active Comparator | 5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decapeptyl Daily | Drug | Decapeptyl 0.2 mg SC once 1day |
|
| Measure | Description | Time Frame |
|---|---|---|
| MII Oocytes | the number of mature oocytes retrieved | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Rate | the number of pregnancies obtained, wich still is the most important issue for the patients | 12 weeks |
| Patients With Cryopreserved Embryos | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wim Decleer, gynacologist | IVF Centrum Jan Palfijn Gent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A Z Jan Palfijn | Ghent | Oost-vlaanderen | 9000 | Belgium |
the Principal Investigator (PI) prescreened the patients and only the eligible patients were assigned to a group by the study coordinator
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| ID | Title | Description |
|---|---|---|
| FG000 | hCG Triggering | TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL |
| FG001 | hCG and GnRH Agonist Triggering | DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HCG TRIGGERING | TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL |
| BG001 | hCG and GnRH Agonist Triggering | DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | MII Oocytes | the number of mature oocytes retrieved | Posted | Mean | Standard Deviation | cumulus oocyte complex | 3 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | hCG TRIGGERING | TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| OHSS | Metabolism and nutrition disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| dr.Decleer Wim | AZ JAN PALFIJN | +32 9 325 92 20 | 092248851 | wim.decleer@janpalfijngent.be |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D006063 | Chorionic Gonadotropin |
| ID | Term |
|---|---|
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| pregnyl | Drug | 5000 IU SC |
|
| BG002 | Total | Total of all reporting groups |
| YEARS |
|
| Sex: Female, Male | FEMALE | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Participants |
|
|
| Secondary | Pregnancy Rate | the number of pregnancies obtained, wich still is the most important issue for the patients | Posted | Number | pregnancies | 12 weeks |
|
|
|
| Secondary | Patients With Cryopreserved Embryos | Posted | Number | patients with cryopreserved embryos | 4 weeks |
|
|
|
|
| 0 |
| 59 |
| 0 |
| 59 |
| EG001 | hCG and GnRH Agonist Triggering | DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL | 0 | 61 | 0 | 61 |
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| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |