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The purpose of this study is to possibly further improve the clinical outcome and explore the incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin) in GnRH antagonist IVF/ICSI cycles
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) |
|
| B | Active Comparator | More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.) |
|
| C | Experimental | 14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5) |
|
| D | Active Comparator | 14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buserelin and Pregnyl | Drug | Subcutaneous injection 0.5 mg and 1500 IU |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Moderate to Severe OHSS. | From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Rate | from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter S Humaidan, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fertility Clinic, Regional Hospital of Skive | Skive | 7800 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23753114 | Derived | Humaidan P, Polyzos NP, Alsbjerg B, Erb K, Mikkelsen AL, Elbaek HO, Papanikolaou EG, Andersen CY. GnRHa trigger and individualized luteal phase hCG support according to ovarian response to stimulation: two prospective randomized controlled multi-centre studies in IVF patients. Hum Reprod. 2013 Sep;28(9):2511-21. doi: 10.1093/humrep/det249. Epub 2013 Jun 9. |
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Recruitment period from jan. 2009 to dec. 2011. Participanting Clinics Fertility clinic Regional Hospital Skive, University Hostipal Odense, Regional Hospital Holbaek, Denmark.
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| ID | Title | Description |
|---|---|---|
| FG000 | A: >14 Follicles; GnRHa Trigger + 1500 hCG | More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU |
| FG001 | B: >14 Follicles; hCG Trigger | More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.) Pregnyl : Subcutaneous injection 5000 IU |
| FG002 | C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 | 14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5) Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days |
| FG003 | D: <15 Follicles; hCG Trigger | 14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.) Pregnyl : Subcutaneous injection 5000 IU |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A: >14 Follicles; GnRHa Trigger + 1500 hCG | More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU |
| BG001 | B: >14 Follicles; hCG Trigger |
| 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 | Frequency of Moderate to Severe OHSS. | No power calculation was proformed. | Posted | Number | participants | From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test |
|
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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 | A: >14 Follicles; GnRHa Trigger + 1500 hCG | More than 14 follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Humaidan | Fertility Clinic Regional Hospital Skive | +45 78 44 57 60 | peter.humaidan@viborg.rm.dk |
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| ID | Term |
|---|---|
| D016471 | Ovarian Hyperstimulation Syndrome |
| ID | Term |
|---|---|
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D002064 | Buserelin |
| D006063 | Chorionic Gonadotropin |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Pregnyl |
| Drug |
Subcutaneous injection 5000 IU |
|
| Buserelin and Pregnyl | Drug | Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days |
|
| Pregnyl | Drug | Subcutaneous injection 5000 IU |
|
More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.) Pregnyl : Subcutaneous injection 5000 IU |
| BG002 | C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 | 14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5) Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days |
| BG003 | D: <15 Follicles; hCG Trigger | 14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.) Pregnyl : Subcutaneous injection 5000 IU |
| BG004 | 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 |
|
| OG002 | C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 | 14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5) Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days |
| OG003 | D: <15 Follicles; hCG Trigger | 14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.) Pregnyl : Subcutaneous injection 5000 IU |
|
|
| Secondary | Pregnancy Rate | Posted | Number | participants | from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | B: >14 Follicles; hCG Trigger | More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.) Pregnyl : Subcutaneous injection 5000 IU | 0 | 58 | 0 | 58 |
| EG002 | C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 | 14 or less follicles with a diameter of > 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5) Buserelin and Pregnyl : Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days | 0 | 125 | 0 | 125 |
| EG003 | D: <15 Follicles; hCG Trigger | 14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.) Pregnyl : Subcutaneous injection 5000 IU | 0 | 141 | 0 | 141 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| 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 |
| D006062 | Gonadotropins |
| D010926 | Placental Hormones |
| D011257 | Pregnancy Proteins |