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The main purpose of this clinical research study is to investigate if degarelix can synchronise the growth of the egg sacs in the ovaries and if degarelix has any effect on the lining of the womb.
For the primary end-point (data collected on Stimulation Day 1), the study will compare degarelix 2.5 mg administered in the mid-luteal phase to placebo administered in the mid-luteal phase.
After Stimulation Day 1 the placebo group will be split into two groups: a degarelix 2.5 mg follicular group and a ganirelix 0.25 mg group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Degarelix mid-luteal, 2.5 mg | Experimental | Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1. |
|
| Placebo | Placebo Comparator | Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6. or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Degarelix mid-luteal, 2.5 mg | Drug | Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm) | Explanation of the term "coefficient of variation": The coefficient of variation is a normalized measure of dispersion of a probability distribution. | Stimulation Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Oocyte Donors With Adequate Secretory Transformation at the Endometrial Histology Evaluation 7 Days After Injection With Human Chorionic Gonadotrophin (hCG) | An adequate secretory endometrium 7 days after hCG injection was defined as secretory in the histological classification and with endometrial dating corresponding to the expected cycle day ±1 day. | 7 days after hCG injection |
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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 |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | Belgium | ||||
| ISCARE IVF a.s. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22197127 | Derived | Garcia-Velasco JA, Kupesic S, Pellicer A, Bourgain C, Simon C, Mrazek M, Devroey P, Arce JC. Follicular and endocrine profiles associated with different GnRH-antagonist regimens: a randomized controlled trial. Reprod Biomed Online. 2012 Feb;24(2):153-62. doi: 10.1016/j.rbmo.2011.10.016. Epub 2011 Nov 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Degarelix Mid-luteal, 2.5 mg | Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1. |
| FG001 | Placebo | Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6. or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Degarelix Mid-luteal, 2.5 mg | Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Intention-to-treat (ITT) population |
| 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 | Coefficient of Variation of Follicular Sizes on Stimulation Day 1 (Follicles ≥ 2 mm) | Explanation of the term "coefficient of variation": The coefficient of variation is a normalized measure of dispersion of a probability distribution. | Posted | Mean | Standard Deviation | Percentage | Stimulation Day 1 |
|
From signed informed consent till end-of-trial visit (approximately 12 +/- 2 weeks after oocyte retrieval)
Evaluated at each trial visit
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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 | Degarelix, 2.5 mg | Combination of these two groups: Degarelix Mid-luteal 2.5 mg and Degarelix Follicular 2.5 mg. Degarelix Mid-luteal, 2.5 mg: Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1. Degarelix Follicular, 2.5 mg: Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ferring Pharmaceuticals | Clinical Development Support | DK0-Disclosure@ferring.com |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Placebo | Drug | Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6. or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day. |
|
| Prague |
| Czechia |
| IVI-Madrid | Madrid | Spain |
| IVI-Valencia | Valencia | Spain |
| Personal reasons |
|
| Large follicle size |
|
| Low follicular response. |
|
| Travelling of subject. |
|
Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.
or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age Continuous | ITT population | Mean | Standard Deviation | years |
|
| Sex: Female, Male | ITT population | Count of Participants | Participants |
|
| Region of Enrollment | ITT population | Number | participants |
|
|
|
| Secondary | Frequency of Oocyte Donors With Adequate Secretory Transformation at the Endometrial Histology Evaluation 7 Days After Injection With Human Chorionic Gonadotrophin (hCG) | An adequate secretory endometrium 7 days after hCG injection was defined as secretory in the histological classification and with endometrial dating corresponding to the expected cycle day ±1 day. | Subjects with evaluable endometrial biopsies 7 days after injection with hCG. | Posted | Number | Participants | 7 days after hCG injection |
|
|
|
| 1 |
| 63 |
| 7 |
| 63 |
| EG001 | Ganirelix, 0.25 mg | Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day. | 0 | 22 | 4 | 22 |
| Allergy to arthropod bite | Immune system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Mood swings | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
|
| Menstruation delayed | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Uterine polyp | Reproductive system and breast disorders | MedDRA 10.0 | 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.
| D000091662 | Genital Diseases |
| D007246 | Infertility |