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| Name | Class |
|---|---|
| Selcuk University | OTHER |
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The investigators aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. The investigators evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients.
Aim
-We aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. We evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients.
Material and Methods -Between 01.01.2009-30.04.2011, 137 patients presented with infertility to the unit of Assisted Reproduction Techniques- of the Department of Obstetrics and Gynecology- Meram Medical Faculty- Selcuk University and were planned for ICSI-ET (intracytoplasmic sperm injection-embryo transfer) with normal ovarian function, who had long protocol of GnRH analogue and COH (controlled ovarian hyperstimulation) with rFSH were included in the study. 52 patients were considered responsive to stimulation and composed the normal control group (Group 1). On the 7th day of stimulation transvaginal ultrasonography was carried out. Patients who had at least 6 follicles about 6-10mm but had no follicle above 10mm and E2 (Oestradiol) level of <250 pg / ml were considered to have suboptimal response to stimulation and were divided into two groups. For Group 2 (n = 50), 75IU / L rLH was added to the treatment, for Group 3 (n = 35), 75IU / L of rFSH was added to the treatment. IVF results were compared between the groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fix dose r-FSH (Gonal-f) | Active Comparator | The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1 |
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| r-LH supplementation to r-FSH | Active Comparator | On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment. |
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| r-FSH (Gonal-f) | Active Comparator | Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fix dose r-FSH (Gonal-f) | Drug | recombinant follicle stimulation |
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| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy Rate | percentage of participants with a pregnancy (a b-HCG determination was obtained and considered positive if the value was greater than 10 mIU/ml) | Up to 9 month |
| Measure | Description | Time Frame |
|---|---|---|
| the Number of Oocytes Retrieved | median number of oocytes retrieved per participant | up to 9 month |
| Number of Mature Oocyte | median number of mature oocytes retrieved per participant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| fatma yazıcı yılmaz, MD | Sisli Etfal training and research hospital | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fix Dose r-FSH (Gonal-f) | The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1 fix dose r-FSH (Gonal-f): recombinant follicle stimulation |
| FG001 | r-LH Supplementation to r-FSH |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| r-LH supplementation | Drug | recombinant luteinizing hormone |
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| r-FSH (Gonal-f) | Drug | recombinant follicle stimulation hormone |
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| up to 9 month |
| Fertilization Rate | fertilization rate used to measure how many oocytes become fertilized by sperm cells | up to 9 month |
| Implantation Rates | Implantation rate is the percentage of embryos which successfully undergo implantation | up to 9 months |
On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment. r-LH supplementation: recombinant luteinizing hormone |
| FG002 | r-FSH (Gonal-f) | Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation. r-FSH (Gonal-f): recombinant follicle stimulation hormone |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fix Dose r-FSH (Gonal-f) | The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1 fix dose r-FSH (Gonal-f): recombinant follicle stimulation |
| BG001 | r-LH Supplementation to r-FSH | On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment. r-LH supplementation: recombinant luteinizing hormone |
| BG002 | r-FSH (Gonal-f) | Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation. r-FSH (Gonal-f): recombinant follicle stimulation hormone |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | ||||||||||||||||||||||||||
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| Primary | Pregnancy Rate | percentage of participants with a pregnancy (a b-HCG determination was obtained and considered positive if the value was greater than 10 mIU/ml) | In Group 1, transfer procedure could not be performed one patient. In Group 2, the cycle was cancelled in two patients. Oocyte could not be obtained in one patient during OPU. In other 2 patients, transfer couldn't be done. In Group 3 transfer procedure could not be performed in one patient. The pregnancy rates per embryo transfer were calculated. | Posted | Number | percentage of pregnant participants | Up to 9 month |
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| Secondary | the Number of Oocytes Retrieved | median number of oocytes retrieved per participant | Posted | Median | Standard Deviation | oocytes | up to 9 month |
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| Secondary | Number of Mature Oocyte | median number of mature oocytes retrieved per participant | Posted | Median | Standard Deviation | oocytes | up to 9 month |
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| Secondary | Fertilization Rate | fertilization rate used to measure how many oocytes become fertilized by sperm cells | Posted | Number | percentage of fertilized oocytes | up to 9 month |
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| Secondary | Implantation Rates | Implantation rate is the percentage of embryos which successfully undergo implantation | Posted | Number | percentage of embryo implantation | up to 9 months |
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Serious and/or other [non-serious] adverse events were not collected/assessed
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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 | Fix Dose r-FSH (Gonal-f) | The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1 fix dose r-FSH (Gonal-f): recombinant follicle stimulation | 0 | 0 | 0 | 0 | ||
| EG001 | r-LH Supplementation to r-FSH | On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment. r-LH supplementation: recombinant luteinizing hormone | 0 | 0 | 0 | 0 | ||
| EG002 | r-FSH (Gonal-f) | Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation. r-FSH (Gonal-f): recombinant follicle stimulation hormone | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fatma yazıcı yılmaz | Sisli etfal training anf research hospital | +905079234033 | fatmayazc@gmail.com |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C571801 | follitropin alfa |
| C571802 | follitropin beta |
| D037101 | Luteinizing Hormone, beta Subunit |
| ID | Term |
|---|---|
| D007986 | Luteinizing Hormone |
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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