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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001307-35 | Registry Identifier | EudraCT |
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Prospective open label, randomised, parallel group, comparative pilot.
Ongoing pregnancy rate, defined as positive fetal heart action 9 weeks after the first positive pregnancy test. Number/diameter of follicles, number of oocytes retrieved, number of pronuclear oocytes (referred to as zygotes or pre-embryos in the UK), quality of pronuclear stage oocytes, number of embryos transferred, quality of embryos, number of frozen embryos, endometrial thickness and morphology on day of HCG administration, estradiol levels at day of HCG administration, implantation rate, number of days stimulated with gonadotrophins and number of ampoules used, clinical pregnancy rate at 6 weeks after the first positive pregnancy test, pregnancy outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Menotrophin | Experimental |
| |
| Follitropin alfa | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menotrophin | Drug | 150 IU Menotrophin daily subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Ongoing Pregnancy | Number of participants who met human chorionic gonadotrophin (hCG) criterion, received an embryo transfer, tested positive with a serum pregnancy test 11-14 days after embryo transfer and had an ongoing pregnancy (defined as positive fetal heart action) at ≥ 9 weeks after the first positive pregnancy test. | Approx week 13; 9 weeks or more after the 1st positive pregnancy test |
| Percentage of Participants With an Ongoing Pregnancy | Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action. | Approx week 13; 9 weeks or more after the first positive pregnancy test |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | The criterion for ovulation induction was three follicles ≥ 17 mm diameter as shown by pelvic ultrasound examination. Patients were assessed by pelvic ultrasound on the morning (prior to menotrophin or follitropin alfa administration) of Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) until the criterion was met. |
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Female patients aged > or = 20 and < or = 35 years with a BMI of >18 and <32 kg/m2 who have received no more than two previous cycles of in vitro fertilisation (IVF) or other assisted reproductive technique (ART) and whose partners have normal sperm (according to WHO 1999 criteria).
Inclusion criteria:
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gemeinschaftspraxis und Tagesklinik, Olpe 19 | Dortmund | 44135 | Germany | |||
| Universitats-Frauenklinik Heidelberg Abt. Gynakologische Endokrinologie und Fertilitatsstorungen, Voßstr. 9 |
Ninety (90) participants were screened and 80 participants randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Menotrophin | Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG) |
| FG001 | Follitropin Alfa | A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Menotrophin | Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG) |
| BG001 | Follitropin Alfa | A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)). |
| 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 | Number of Participants With an Ongoing Pregnancy | Number of participants who met human chorionic gonadotrophin (hCG) criterion, received an embryo transfer, tested positive with a serum pregnancy test 11-14 days after embryo transfer and had an ongoing pregnancy (defined as positive fetal heart action) at ≥ 9 weeks after the first positive pregnancy test. | All patients treated population | Posted | Number | participants | Approx week 13; 9 weeks or more after the 1st positive pregnancy test |
|
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The 'all patients treated' population is the same as the safety population in this study.
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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 | Menotrophin | Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | DK0-Disclosure@ferring.com |
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008596 | Menotropins |
| C571801 | follitropin alfa |
| ID | Term |
|---|---|
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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|
| Follitropin alfa | Drug | 150 IU follitropin alfa daily by subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily. |
|
|
| Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) |
| Participants With Varying Numbers of Oocytes Retrieved | Number of participants with grouped by the number of oocytes retrieved. Oocytes were retrieved following ovulation induction by subcutaneous administration of human chorionic gonadotrophin (hCG) in the form of choriogonadotropin alfa at a dose of 250 micrograms once participants reached the criteria of at least three follicles with >= 17mm in diameter. | Approximately study day 15 |
| Participants With Varying Numbers of Pronuclear Stage Oocytes | Number of participants with various groupings of pronuclear oocytes retrieved 16-20 hours after insemination. | Approximately study day 15 |
| Participants With Varying Numbers of Embryos Transferred | Number of participants with various categories of numbers of embryos transferred. | Approximately study day 17 |
| Participants With Varying Numbers of Embryos Frozen | Number of participants with different categories of number of embryos frozen. | Approximately study day 17 |
| Mean Number of Days Stimulated With Gonadotrophins | Number of days stimulated with study drug until participant met the criteria for ovulation induction. Ovulation induction criteria is three follicles greater than or equal to 17 mm diameter as shown by pelvic ultrasound examination. | study days 1 - 13 |
| Pregnancy Outcomes | Long term follow-up to determine the outcome of the pregnancy. | Approximately 10 months |
| Mean Endometrial Thickness | Measurement performed on day of human chorionic gonadotrophin (hCG) administration/ovulation induction. | Day 7 or 9 or 11 or 13 |
| Mean Estradiol Level | Measurement on day of human chorionic gonadotrophin (hCG) administration / ovulation induction. | Day 7 or 9 or 11 or 13 |
| Heidelberg |
| 69115 |
| Germany |
| Gemeinschaftspraxis und Tagesklinik, Zingel 29 | Hildesheim | 1134 | Germany |
| Royal Infirmary of Edinburgh, 51 Little France | Edinburgh | EH16 4SA | United Kingdom |
| Leeds General Infirmary, Great George Street | Leeds | LS1 3EX | United Kingdom |
| The Royal Hallamshire Hospital, University of Sheffield, Jessop Wing, Tree Root Walk | Sheffield | S10 2SF | United Kingdom |
| Did not meet hCG criterion |
|
| other reason |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Tobacco Use | Number | participants |
|
| Body Mass Index | Body mass index (BMI) is measure of body fat based on height and weight that applies to both adult men and women | Mean | Standard Deviation | Kilograms/Meters squared |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
| Pulse | Mean | Standard Deviation | beats per minute |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
|
|
|
| Primary | Percentage of Participants With an Ongoing Pregnancy | Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action. | All patients treated population. Two menotrophin patients did not have pregnancy outcome data recorded in this timeframe but were later recorded as having live births so are included here as "YES" for ongoing pregnancy. | Posted | Number | percentage of participants | Approx week 13; 9 weeks or more after the first positive pregnancy test |
|
|
|
|
| Secondary | Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters | The criterion for ovulation induction was three follicles ≥ 17 mm diameter as shown by pelvic ultrasound examination. Patients were assessed by pelvic ultrasound on the morning (prior to menotrophin or follitropin alfa administration) of Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) until the criterion was met. | All treated patients population | Posted | Number | participants | Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13) |
|
|
|
| Secondary | Participants With Varying Numbers of Oocytes Retrieved | Number of participants with grouped by the number of oocytes retrieved. Oocytes were retrieved following ovulation induction by subcutaneous administration of human chorionic gonadotrophin (hCG) in the form of choriogonadotropin alfa at a dose of 250 micrograms once participants reached the criteria of at least three follicles with >= 17mm in diameter. | All treated patients population. | Posted | Number | participants | Approximately study day 15 |
|
|
|
| Secondary | Participants With Varying Numbers of Pronuclear Stage Oocytes | Number of participants with various groupings of pronuclear oocytes retrieved 16-20 hours after insemination. | All patients treated population | Posted | Number | participants | Approximately study day 15 |
|
|
|
| Secondary | Participants With Varying Numbers of Embryos Transferred | Number of participants with various categories of numbers of embryos transferred. | All patients treated population | Posted | Number | participants | Approximately study day 17 |
|
|
|
| Secondary | Participants With Varying Numbers of Embryos Frozen | Number of participants with different categories of number of embryos frozen. | All patients treated population | Posted | Number | participants | Approximately study day 17 |
|
|
|
| Secondary | Mean Number of Days Stimulated With Gonadotrophins | Number of days stimulated with study drug until participant met the criteria for ovulation induction. Ovulation induction criteria is three follicles greater than or equal to 17 mm diameter as shown by pelvic ultrasound examination. | All patients treated population | Posted | Mean | Standard Deviation | days | study days 1 - 13 |
|
|
|
| Secondary | Pregnancy Outcomes | Long term follow-up to determine the outcome of the pregnancy. | All patients treated population | Posted | Number | participants | Approximately 10 months |
|
|
|
| Secondary | Mean Endometrial Thickness | Measurement performed on day of human chorionic gonadotrophin (hCG) administration/ovulation induction. | All patients treated population | Posted | Mean | Standard Deviation | millimeters | Day 7 or 9 or 11 or 13 |
|
|
|
| Secondary | Mean Estradiol Level | Measurement on day of human chorionic gonadotrophin (hCG) administration / ovulation induction. | All patient treated population | Posted | Mean | Standard Deviation | picomoles / liter | Day 7 or 9 or 11 or 13 |
|
|
|
| 4 |
| 37 |
| 18 |
| 37 |
| EG001 | Follitropin Alfa | A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)). | 9 | 39 | 21 | 39 |
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 7.1 | Systematic Assessment |
|
| Abortion Imminent | Pregnancy, puerperium and perinatal conditions | MedDRA 7.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 7.1 | Systematic Assessment |
|
| Ovarian Hyperstimulation Syndrome | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
|
| Uterine Haemorrhage | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
|
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection Site Bruising | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection Site Haemorrhage | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection Site Pruritus | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection Site Rash | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Injection Site Swelling | General disorders | MedDRA 7.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 7.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 7.1 | Systematic Assessment |
|
| Breast Tenderness | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
|
| Ovarian Hyperstimulation Syndrome | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
|
| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA 7.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
| Skin Reaction | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Systematic Assessment |
|
The only disclosure restiction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript.
| 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 |
| 4 follicles ≥ 17 mm in diameter |
|
| 5 follicles ≥ 17 mm in diameter |
|
| 6 follicles ≥ 17 mm in diameter |
|
| 7 follicles ≥ 17 mm in diameter |
|
| 8 follicles ≥ 17 mm in diameter |
|
| 9 follicles ≥ 17 mm in diameter |
|
| 10 follicles ≥ 17 mm in diameter |
|
| 11-14 follicles ≥ 17 mm in diameter |
|
| 15 follicles ≥ 17 mm in diameter |
|
| 16 follicles ≥ 17 mm in diameter |
|
| 2 oocytes retrieved |
|
| 3 oocytes retrieved |
|
| 4 oocytes retrieved |
|
| 5 oocytes retrieved |
|
| 6 oocytes retrieved |
|
| 7 oocytes retrieved |
|
| 8 oocytes retrieved |
|
| 9 oocytes retrieved |
|
| 10 oocytes retrieved |
|
| 11 oocytes retrieved |
|
| 12 oocytes retrieved |
|
| 13 oocytes retrieved |
|
| 14 oocytes retrieved |
|
| 15 oocytes retrieved |
|
| 16 oocytes retrieved |
|
| 17-18 oocytes retrieved |
|
| 19 oocytes retrieved |
|
| 20 oocytes retrieved |
|
| 21 oocytes retrieved |
|
| 22 oocytes retrieved |
|
| 23 oocytes retrieved |
|
| 3 pronuclear stage oocytes |
|
| 4 pronuclear stage oocytes |
|
| 5 pronuclear stage oocytes |
|
| 6 pronuclear stage oocytes |
|
| 7 pronuclear stage oocytes |
|
| 8 pronuclear stage oocytes |
|
| 9 pronuclear stage oocytes |
|
| 10 pronuclear stage oocytes |
|
| 11 pronuclear stage oocytes |
|
| 12 pronuclear stage oocytes |
|
| 13 pronuclear stage oocytes |
|
| 14-16 pronuclear stage oocytes |
|
| 17 pronuclear stage oocytes |
|
| 2 embryos transferred |
|
| 3 embryos transferred |
|
| 2 embryos frozen |
|
| 3 embryos frozen |
|
| 4 embryos frozen |
|
| 5 embryos frozen |
|
| 6-8 embryos frozen |
|
| 9 embryos frozen |
|
| 10 embryos frozen |
|
| Pre-term: 2 live births |
|
| Pre-term stillbirth |
|
| Full term: 1 live birth |
|
| Full term: 2 live births |
|