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The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fostimon® | Experimental | 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) |
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| Gonal-F® | Active Comparator | 75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urofollitrophin | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy Rate | A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation; | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Follicles >16 mm on the Day of hCG Injection | 10-15 days after starting FSH stimulation | |
| Total Number of Oocytes Retrieved | end of treatment period, approximately 2 - 3 weeks. | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pedro Barri, MD | Institut Universitari Dexeus, Barcelona, Spain | Study Chair |
| Christophe Blockeel, MD | Universitair Ziekenhuis Brussel, Belgium | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCL- Cliniques Universitaires Saint Luc | Brussels | Belgium | ||||
| Universitair Ziekenhuis Brussel |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fostimon® | 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) Urofollitrophin |
| FG001 | Gonal-F® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Follitrophin alpha |
| Drug |
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| Fertilization Rate |
| end of treatment period, approximately 2 - 3 weeks |
| Embryo Quality (Number of Top Quality Embryos Transferred Per Patient) | The embryo quality evaluation will be performed on culture day 3, just before embryo transfer and will consist in the assessment of blastomeres number and 2 embryo morphology parameters: degree of fragmentation and cell division aspect. | On culture day 3 |
| Positive Serum Pregnancy Test Rate | Two weeks after embryo transfer, a serum pregnancy test will be performed. | 2 weeks after embryo transfer |
| Delivery Rate | 9 months |
| Cumulative Pregnancy Rate | Patients who will not get pregnant during the study, will be allowed to perform a frozen embryo transfer. Cumulative pregnancy rate will include also pregnancies achieved after a frozen embryo transfer. | 2 years |
| Brussels |
| Belgium |
| Spedali Civili di Brescia | Brescia | Italy |
| Fondazione Ca'Granda, Osp Maggiore Policlinico | Milan | Italy |
| IRCCS San Raffaele | Milan | Italy |
| Università degli Studi di Napoli 'Federico II' | Naples | Italy |
| Azienda Ospedaliera Di Reggio Emilia | Reggio Emilia | Italy |
| Clinica IVI Alicante | Alicante | 03015 | Spain |
| Institut Universitari Dexeus | Barcelona | 8028 | Spain |
| Ginefiv Clínica de Fertilidad | Madrid | Spain |
| Instituto Valenciano de Infertilidad (IVI) | Seville | 40011 | Spain |
| Universitäts-Frauenklinik | Basel | Canton of Basel-City | Switzerland |
| Universitätsklinik für Frauenheilkunde | Bern | Canton of Bern | Switzerland |
| Prof. Bülent Urman | Istanbul | Turkey (Türkiye) |
| Ege University | Izmir | Turkey (Türkiye) |
| Midland Fertility Services | Aldridge | United Kingdom |
75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)
Follitrophin alpha
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fostimon® | 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) Urofollitrophin |
| BG001 | Gonal-F® | 75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) Follitrophin alpha |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | Clinical Pregnancy Rate | A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation; | Posted | Number | percentage of participants | 8 weeks |
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| Secondary | Number of Follicles >16 mm on the Day of hCG Injection | Subject with available data. | Posted | Mean | Standard Deviation | follicles >16 mm | 10-15 days after starting FSH stimulation |
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| Secondary | Total Number of Oocytes Retrieved | subjects who underwent oocytes retrieval | Posted | Mean | Standard Deviation | oocytes | end of treatment period, approximately 2 - 3 weeks. |
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| Secondary | Fertilization Rate | subjects with at least one oocyte inseminated. | Posted | Mean | Standard Deviation | percentage of oocytes | end of treatment period, approximately 2 - 3 weeks |
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| Secondary | Embryo Quality (Number of Top Quality Embryos Transferred Per Patient) | The embryo quality evaluation will be performed on culture day 3, just before embryo transfer and will consist in the assessment of blastomeres number and 2 embryo morphology parameters: degree of fragmentation and cell division aspect. | Subject with at least one embryo transferred, with embryo scoring available. | Posted | Mean | Standard Deviation | Top embryos | On culture day 3 |
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| Secondary | Positive Serum Pregnancy Test Rate | Two weeks after embryo transfer, a serum pregnancy test will be performed. | Posted | Number | percentage of participants | 2 weeks after embryo transfer |
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| Secondary | Delivery Rate | For 4 patients, 3 allocated to the Fostimon® group and 1 allocated to the Gonal-F® group this information was not available because of lost to follow-up. | Posted | Number | percentage of participants | 9 months |
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| Secondary | Cumulative Pregnancy Rate | Patients who will not get pregnant during the study, will be allowed to perform a frozen embryo transfer. Cumulative pregnancy rate will include also pregnancies achieved after a frozen embryo transfer. | Posted | Number | percentage of participants | 2 years |
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Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).
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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 | Fostimon® | 75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) Urofollitrophin | 0 | 352 | 24 | 352 | 36 | 352 |
| EG001 | Gonal-F® | 75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) Follitrophin alpha | 0 | 358 | 31 | 358 | 42 | 358 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Abortion induced | Surgical and medical procedures | MedDRA (19.0) | Systematic Assessment |
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| seizure | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Abortion early | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| Abortion incomplete | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| abortion missed | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| Cervical incompetence | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| gestational diabetes | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| Hyperemesis gravidarum | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| imminent abortion | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| Multiple pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| Oligohydramniosis | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| Placenta praevia haemorrage | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| Postpartum haemorrage | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| premature delivery | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| Threatened labour | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| Vomiting in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| abdominal pain lower | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| intra abdominal haemorrage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| peritoneal haemorrage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Adnexal torsion | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
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| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
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| pelvic pain | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
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| Uterine polyp | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
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| Vaginal haemorrage | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | Systematic Assessment |
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| infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (19.0) | Systematic Assessment |
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| Vaginal haemorrage | Reproductive system and breast disorders | MedDRA (19.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Project Leader | IBSA Insitut Biochimique | +41 58 360 10 00 | rd@ibsa.ch |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D050477 | Urofollitropin |
| D015292 | Glycoprotein Hormones, alpha Subunit |
| ID | Term |
|---|---|
| D008596 | Menotropins |
| 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 |
| D006063 | Chorionic Gonadotropin |
| D005640 | Follicle Stimulating Hormone |
| D007986 | Luteinizing Hormone |
| D013972 | Thyrotropin |
| D010926 | Placental Hormones |
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| Male |
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| Black |
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| Asian |
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| American Indian or Alaska native |
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| Belgium |
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| United Kingdom |
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| Italy |
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| Switzerland |
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| Spain |
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