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Ovulation trigger is needed in in vitro fertilization (IVF) to get mature eggs. Routinely, human chorionic gonadotropin (hCG) is used for that purpose given its similarity to the natural hormone that does this job in a natural cycle (luteinizing hormone, LH). In a natural cycle another hormone takes part in the process (follicle stimulating hormone, FSH). To induce a natural-like ovulation surge that includes LH and FSH , gonadotropin releasing hormone (GnRH) agonist can be given.
The purpose of this study is to find out which approach may work better in IVF patients who experienced 4 IVF failures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hCG trigger | Active Comparator | Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily. |
|
| GnRH agonist trigger | Experimental | ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GnRH agonist trigger | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Heart Activity 1 Month After Oocyte Retrieval | Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval | 1 month after oocyte retrieval |
| Measure | Description | Time Frame |
|---|---|---|
| Patients Comfort During the Luteal Phase | During 2 weeks from day of oocyte retrieval |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IVF Unit, Rambam medical Center | Haifa | Israel | 31096 | Israel |
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| ID | Title | Description |
|---|---|---|
| FG000 | hCG Trigger | Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily. hCG trigger |
| FG001 | GnRH Agonist Trigger | ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG. GnRH agonist trigger |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | hCG Trigger | Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily. hCG trigger |
| BG001 | GnRH Agonist Trigger | ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG. GnRH agonist trigger |
| 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 | Fetal Heart Activity 1 Month After Oocyte Retrieval | Fetal heart activity as seen by vaginal ultrsound imaging 1 month after oocyte retrieval | Posted | Number | participants with fetal heart activity | 1 month after oocyte retrieval |
|
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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 Trigger | Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily. hCG trigger |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shahar Kol Director IVF Unit | Rambam health Care campus | 97247773232 | skol@rambam.health.gov.il |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| hCG trigger | Drug |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Patients Comfort During the Luteal Phase | Not Posted | During 2 weeks from day of oocyte retrieval |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | GnRH Agonist Trigger | ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG. GnRH agonist trigger | 0 | 1 | 0 | 1 |
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| 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 |