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The purpose of this randomized pilot study is to compare the efficacy of double oocyte retrieval vs. conventional antagonist ovarian stimulation protocol in poor prognosis patients undergoing in vitro fertilization (IVF) or intra-cytoplasmic sperm injection (ICSI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | ||
| double pick up group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corifollitoropin alfa (CFA)-double pick up | Drug | In the study group, 225 IU of recombinant FSH (rFSH) will continue after the first oocyte retrieval (OR). Antagonist administration will be initiated when at least one follicle measuring ≥14 mm will be present in the ultrasound. If one or more follicles ≥17 mm are observed, patients will undergo a second triggering with human chorionic gonadotropin (hCG) 5000 IU and a second OR will be performed. In case of patients with no follicular development following 10 additional days of rFSH post-OR |
| Measure | Description | Time Frame |
|---|---|---|
| Number of MII Oocytes Retrieved Between the Two Arms | number of mature (or metaphase II, MII) oocytes retrieved during oocyte retrieval | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Preovulatory Follicles | number of follicles ≥11m on the day of final oocyte maturation trigger | 1 month |
| Number of Cumulus Oocyte Complexes (COCs) Retrieved | number of COCs retrieved at oocyte retrieval |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | Jette | 1090 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38199789 | Derived | Boudry L, Mateizel I, Wouters K, Papaleo E, Mackens S, De Vos M, Racca A, Adriaenssens T, Tournaye H, Blockeel C. Does dual oocyte retrieval with continuous FSH administration increase the number of mature oocytes in low responders? An open-label randomized controlled trial. Hum Reprod. 2024 Mar 1;39(3):538-547. doi: 10.1093/humrep/dead276. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | conventional stimulation group |
| FG001 | Double Pick up Group | CFA-double pick up: In the study group, 225 IU of rFSH will continue after the first oocyte retrieval (OR). Antagonist administration will be initiated when at least one follicle measuring ≥14 mm will be present in the ultrasound. If one or more follicles ≥17 mm are observed, patients will undergo a second triggering with hCG 5000 IU and a second OR will be performed. In case of patients with no follicular development following 10 additional days of rFSH post-OR |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group A (control group) underwent conventional triggering with hCG 5000 IU and a single oocyte retrieval (OR) |
| BG001 |
| 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 | Number of MII Oocytes Retrieved Between the Two Arms | number of mature (or metaphase II, MII) oocytes retrieved during oocyte retrieval | Posted | Mean | Standard Deviation | number of oocytes | 1 month |
|
1 year
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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 | Control Group | conventional stimulation group | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Liese Boudry | Brussels IVF | 024779857 | liese.boudry@uzbrussel.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 3, 2019 | Mar 21, 2023 | Prot_SAP_000.pdf |
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|
| 1 month |
| Number of Oocytes Fertilized | number of fertilized oocytes at day 1 after oocyte retrieval | 1 month |
| Total Number of Available Embryos | number of available embryos at day 3 or day 5 after oocyte retrieval, good quality and therefore transferable | 1 month |
| Duration of Ovarian Stimulation | number of days of ovarian stimulation | 1 month |
| Clinical Pregnancy Rates | clinical pregnancy rate | 4 months |
| Live Birth Rates | number of live births | 12 months |
| Cumulative Live Birth Rates | defined as the first live birth following the transfer of fresh and subsequent frozen-thawed embryos | 24 months |
| Double Pick up Group |
A single injection of 150mcg of corifollitropin alfa was administrated at day 2/3 of the cycle, followed by 225IU of recombinant FSH (rFSH) in a fixed antagonist protocol. Group B (study group) underwent triggering with GnRHagonist. 225 IU of rFSH was continued after the first oocyte retrieval (OR). Antagonist administration was initiated when at least one follicle measuring ≥14 mm was present on the ultrasound. If one or more follicles ≥17 mm were observed, patients underwent a second triggering with hCG 5000 IU and a second OR was performed. In case of patients with no follicular development following 13 additional days of rFSH. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Anti-Müllerian hormone (AMH) | Mean | Standard Deviation | ng/ml |
|
| antral follicle count (AFC) | Mean | Standard Deviation | number of follicles |
|
| basal FSH | Mean | Standard Deviation | IU/L |
|
| infertility duration | Mean | Standard Deviation | years |
|
|
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| Secondary | Number of Preovulatory Follicles | number of follicles ≥11m on the day of final oocyte maturation trigger | Posted | Mean | Standard Deviation | number of follicles | 1 month |
|
|
|
| Secondary | Number of Cumulus Oocyte Complexes (COCs) Retrieved | number of COCs retrieved at oocyte retrieval | Posted | Mean | Standard Deviation | number of oocytes | 1 month |
|
|
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| Secondary | Number of Oocytes Fertilized | number of fertilized oocytes at day 1 after oocyte retrieval | Posted | Mean | Standard Deviation | number of fertilized oocytes | 1 month |
|
|
|
| Secondary | Total Number of Available Embryos | number of available embryos at day 3 or day 5 after oocyte retrieval, good quality and therefore transferable | Posted | Mean | Standard Deviation | number of embryos | 1 month |
|
|
|
| Secondary | Duration of Ovarian Stimulation | number of days of ovarian stimulation | Posted | Mean | Standard Deviation | days | 1 month |
|
|
|
| Secondary | Clinical Pregnancy Rates | clinical pregnancy rate | Posted | Count of Participants | Participants | 4 months |
|
|
|
| Secondary | Live Birth Rates | number of live births | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Secondary | Cumulative Live Birth Rates | defined as the first live birth following the transfer of fresh and subsequent frozen-thawed embryos | Not Posted | 24 months | Participants |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Double Pick up Group | CFA-double pick up: In the study group, 225 IU of rFSH will continue after the first oocyte retrieval (OR). Antagonist administration will be initiated when at least one follicle measuring ≥14 mm will be present in the ultrasound. If one or more follicles ≥17 mm are observed, patients will undergo a second triggering with hCG 5000 IU and a second OR will be performed. In case of patients with no follicular development following 10 additional days of rFSH post-OR | 0 | 24 | 0 | 24 | 0 | 24 |
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