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| Name | Class |
|---|---|
| Onze Lieve Vrouw Hospital | OTHER |
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In this study of endometriosis patients we compare a common treatment of surgical therapy and medical treatment for 3 months (Zoladex) with patients receiving only surgical therapy. In both cases they immediately start In Vitro Fertilization (IVF) treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoladex | Active Comparator | After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. |
|
| vaporization only | No Intervention | Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoladex | Drug | after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Metaphase II Cells (MII) | number of MII cells retrieved | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Rate | The number of ongoing pregnancies obtained which still is the most important issue for the patients. | 12 weeks |
| Good Embryo Quality | The development of the embryo at the time of transfer on day 3. Good quality is defined by more than 7 cells and less then 20% fragmentation on day 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days of Stimulation | number of days needed before follicles in the ovary are mature for oocyte retrieval | 3 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wim Decleer, gynecologist | Fertility Center AZ Jan Palfijn Gent | Principal Investigator |
| Paul Devroey, Professor | Fertility Center AZ Jan Palfijn Gent | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Jan Palfijn | Ghent | Oost-vlaanderen | 9000 | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zoladex | After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months immediately following the start of IVF treatment. |
| FG001 | Vaporization Only | After surgical vaporization of the endometriosis , patients start immediately with IVF treatment (without additional treatment). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
women between 18 and 38 years
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| ID | Title | Description |
|---|---|---|
| BG000 | Zoladex | After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment |
| BG001 | Vaporization Only |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Number of Metaphase II Cells (MII) | number of MII cells retrieved | Posted | Mean | Standard Deviation | MII cells | 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 | Zoladex | After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months. Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| OHSS | Reproductive system and breast disorders | Systematic Assessment | Ovary Hyper Stimulation Syndrome (OHSS) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| miscarriage | Surgical and medical procedures | Systematic Assessment | pregnancy lost in first trimester |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| dr. Wim Decleer, PI | Fertility Center AZ Jan Palfijn | 0032 9 325 92 20 | 09/2248851 | wim.decleer@janpalfijngent.be |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D017273 | Goserelin |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| 3 days after oocyte retrieval |
| Number of Pro Nuclear Cell (2PN) | number of 2PN | 1 day after oocyte retrieval |
| Number of Cryopreserved Embryos | number of blastocytes that can be cryopreserved | 1 week after oocyte retrieval |
| Total Follicle Stimulating Hormone (FSH) Dose | total dose of FSH needed at the end of stimulation | 3 weeks |
Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Pregnancy Rate | The number of ongoing pregnancies obtained which still is the most important issue for the patients. | Posted | Number | percentage of ongoing pregnancies | 12 weeks |
|
|
|
| Secondary | Good Embryo Quality | The development of the embryo at the time of transfer on day 3. Good quality is defined by more than 7 cells and less then 20% fragmentation on day 3. | Posted | Number | percentage of good quality embryos | 3 days after oocyte retrieval |
|
|
|
| Secondary | Number of Pro Nuclear Cell (2PN) | number of 2PN | Posted | Mean | Standard Deviation | number of pro nuclear cells | 1 day after oocyte retrieval |
|
|
|
| Secondary | Number of Cryopreserved Embryos | number of blastocytes that can be cryopreserved | Posted | Mean | Standard Deviation | number of cryopreserved embryos | 1 week after oocyte retrieval |
|
|
|
| Other Pre-specified | Number of Days of Stimulation | number of days needed before follicles in the ovary are mature for oocyte retrieval | Posted | Mean | Standard Deviation | days | 3 weeks |
|
|
|
| Secondary | Total Follicle Stimulating Hormone (FSH) Dose | total dose of FSH needed at the end of stimulation | Posted | Mean | Standard Deviation | IUs | 3 weeks |
|
|
|
| 11 |
| 61 |
| 1 |
| 61 |
| EG001 | Vaporization Only | Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment. | 7 | 58 | 0 | 58 |
|
|
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |