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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021021-13 | EudraCT Number |
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The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hMG-IBSA | Experimental | New hMG preparation. |
|
| Menopur | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menotropins | Drug | Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Oocytes Retrieved | up to 24 days after treatment start |
| Measure | Description | Time Frame |
|---|---|---|
| Mean hMG Dose (Total); | up to 22 days after treatment start | |
| Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo) | Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded. |
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Inclusion Criteria:
Women undergoing ovarian stimulation for IVF with the following characteristics:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique De Ziegler, MD, Prof | Hopital Cochin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fertility clinic at Hvidovre Hospital | Hvidovre | Copenhagen | 2650 | Denmark | ||
| Odense Universitetshospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | hMG-IBSA | New hMG preparation. Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age. |
| FG001 | Menopur | Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | hMG-IBSA | New hMG preparation. Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age. |
| BG001 | Menopur | Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age. |
| 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 | Total Number of Oocytes Retrieved | Posted | Mean | Standard Deviation | number of oocytes | up to 24 days after treatment start |
|
|
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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 | hMG-IBSA | New hMG preparation. Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara Cometti, Senior Clinical Research Manager, IBSA | IBSA Institut Biochimique SA | +41 58 360 10 00 | barbara.cometti@ibsa.ch |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008596 | Menotropins |
| ID | Term |
|---|---|
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Menotropins | Drug | Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age. |
|
| up to 28 days after treatment start |
| Positive b-hCG Test | up to 5 weeks after treatment start |
| Controlled Ovarian Stimulation Duration (Days) | up to 23 days after treatment start |
| 17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection; | up to 23 days after treatment start |
| Implantation Rate | defined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100; | 10-11 weeks after embryo transfer |
| Clinical Pregnancy Rate, | defined as a pregnancy showing ultrasound embryonic heart activity at 10 - 11 weeks after embryo transfer; | 10 - 11 weeks after embryo transfer |
| Number of Mature (Grade III Metaphase II) Oocytes Retrieved. | at the end of the stimulation. |
| Ratio Mature/Total Number of Oocytes Retrieved. | Percentage of retrieved oocytes considered to be mature. | at the end of the stimulation. |
| Total Number of Inseminated Oocytes (IVF and ICSI) | number of oocytes that were inseminated via IVF or injected via ICSI technique. | on the day of oocyte retrieval |
| Number of Cleaved Embryos | two days after insemination |
| Live Birth Rate | 9 months after treatment |
| Odense |
| Odensee C |
| 5000 |
| Denmark |
| Groupe Hospitalier Cochin - Saint Vincent de Paul | Paris | 75014 | France |
| First Dept. Obstetric and Gynaecology, Semmelweiss University | Budapest | 1088 | Hungary |
| Universitätsspital Basel | Basel | Canton of Basel-City | 4031 | Switzerland |
| Midland Fertility Services | Aldridge | West Midlands | WS9 8LT | United Kingdom |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
|
|
|
| Secondary | Mean hMG Dose (Total); | Posted | Mean | Standard Deviation | Internationa Units (IU) | up to 22 days after treatment start |
|
|
|
|
| Secondary | Embryo Quality (Percentage of Patients With at Least One Top Quality Embryo) | Assessed by counting the total number of embryos obtained, the number of embryos transferred, frozen and discarded. | The population analysed corresponds to the patients who had at least one embryo to be analysed (i.e 120 participants in the hMG-IBSA group and 123 in the Menopur group). Of this, 119 in the hMG-IBSA group and 121 in the Menopur group underwent embryo transfer. | Posted | Number | percentage of participants | up to 28 days after treatment start |
|
|
|
| Secondary | Positive b-hCG Test | Posted | Number | percentage of participants | up to 5 weeks after treatment start |
|
|
|
|
| Secondary | Controlled Ovarian Stimulation Duration (Days) | Posted | Mean | Standard Deviation | days | up to 23 days after treatment start |
|
|
|
|
| Secondary | 17-β Estradiol (E2) Serum Concentration on the Monitoring Day Before hCG Injection; | Posted | Mean | Standard Deviation | pg/ml | up to 23 days after treatment start |
|
|
|
| Secondary | Implantation Rate | defined as the mean of the total number of implanted embryos (presence of gestational sac assessed by ultrasound) divided by the total number of transferred embryos x 100; | Posted | Mean | Standard Deviation | percentage of embryos transferred | 10-11 weeks after embryo transfer |
|
|
|
| Secondary | Clinical Pregnancy Rate, | defined as a pregnancy showing ultrasound embryonic heart activity at 10 - 11 weeks after embryo transfer; | Posted | Number | percentage of participants | 10 - 11 weeks after embryo transfer |
|
|
|
|
| Secondary | Number of Mature (Grade III Metaphase II) Oocytes Retrieved. | Posted | Mean | Standard Deviation | oocytes | at the end of the stimulation. |
|
|
|
|
| Secondary | Ratio Mature/Total Number of Oocytes Retrieved. | Percentage of retrieved oocytes considered to be mature. | Posted | Number | percentage of total oocytes retrieved | at the end of the stimulation. |
|
|
|
|
| Secondary | Total Number of Inseminated Oocytes (IVF and ICSI) | number of oocytes that were inseminated via IVF or injected via ICSI technique. | Posted | Mean | Standard Deviation | oocytes | on the day of oocyte retrieval |
|
|
|
|
| Secondary | Number of Cleaved Embryos | Posted | Mean | Standard Deviation | embryos | two days after insemination |
|
|
|
|
| Secondary | Live Birth Rate | Posted | Number | percentage of participants | 9 months after treatment |
|
|
|
|
| 5 |
| 135 |
| 46 |
| 135 |
| EG001 | Menopur | Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age. | 8 | 135 | 42 | 135 |
| Vestibular disorder | Ear and labyrinth disorders | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| peritoneal heamorrage | Gastrointestinal disorders | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Headacje | Nervous system disorders | Systematic Assessment |
|
| Abortion Incomplete | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Abortion Missed | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Hyperemesis gravidarum | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Imminent abortion | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| OHSS | Reproductive system and breast disorders | Systematic Assessment |
|
| Ovarina torsion | Reproductive system and breast disorders | Systematic Assessment |
|
| Vaginal haemorrage | Reproductive system and breast disorders | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Hot flushes | Vascular disorders | Systematic Assessment |
|
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| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |