Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
48 participants
INTERVENTIONAL
2019-10-01
2022-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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control group
No interventions assigned to this group
double pick up group
Corifollitoropin alfa (CFA)-double pick up
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
Interventions
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Corifollitoropin alfa (CFA)-double pick up
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
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) ≤ 35 and ≥ 19
* Antimüllerian hormone (AMH) level of ≤1.5 ng/mL or antral follicular count (AFC) of ≤6 follicles or ≤5 oocytes retrieved in a previous cycle following standard conventional ovarian stimulation.
Exclusion Criteria
* History of \> 3 three consecutive previous unsuccessful IVF cycles
* BMI \>35 or \<19
* Use of oral contraceptives \<3 months before start of the treatment
* polycystic ovary syndrome (PCOS) according to the Rotterdam criteria
* Ovarian stimulation for pre-implantation genetic testing (PGT-A/M)
* Medical/social freezing
* In vitro maturation (IVM)
* History of untreated autoimmune, endocrine or metabolic disorders,
* Ovarian cystectomy or oophorectomy
25 Years
40 Years
FEMALE
No
Sponsors
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CRG UZ Brussel
OTHER
Responsible Party
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Panagiotis Drakopoulos
Prof. Dr.
Locations
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UZ Brussel
Brussels, Jette, Belgium
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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58335
Identifier Type: -
Identifier Source: org_study_id
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