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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-003177-32 | EudraCT Number |
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To evaluate the efficacy of the weekly use of corifollitropin alfa in double ovarian stimulation process and to compare it to the conventional protocol with daily medication administration.
The purpose of this pilot study is to evaluate the efficacy of the weekly use of corifollitropin alfa in terms of ovarian stimulation results and its biological outcomes (total number of oocytes retrieved) in case of ovarian stimulation cycles in double stimulation modality (DUOSTIM) and in comparison with the conventional DUOSTIM protocol: daily administration of gonadotropins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group. |
|
| Control group | Active Comparator | Patients to carry out a conventional double ovarian stimulation and to receive daily injections of gonadotropins. Retrospective group (data retrieved from strictly selected treatments carried out in our institution within the 24 months prior to the inclusion of the first patient in the study group and according to the standard guideline of the clinic). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corifollitropin Alfa | Drug | 150 micrograms per dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Retrieved Oocytes | To investigate the total number of oocytes retrieved through ovarian stimulation in double ovarian stimulation cycles (DUOSTIM) utilizing weekly subcutaneous injections of Corifollitropin alfa (study group) vs. daily injections of gonadotropins (control group). | Through study completion, an average of four weeks |
| Number of MII Oocytes | To compare the total number of MII oocytes obtained in double stimulation cycles in study vs control groups | Through study completion, an average of four months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Ovarian Stimulation | Total days of follicular and luteal phases | Through study completion, an average of four months |
| Number of Injections | Number of injections during the DUOSTIM cycle |
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Inclusion Criteria:
Exclusion Criteria:
Given the aim is to carry out ovarian stimulation, only persons with female reproductive system can be eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Juan Carlos Castillo Farfan, MD, PhD | Instituto Bernabeu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Bernabeu | Alicante | 03016 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12748128 | Result | Baerwald AR, Adams GP, Pierson RA. Characterization of ovarian follicular wave dynamics in women. Biol Reprod. 2003 Sep;69(3):1023-31. doi: 10.1095/biolreprod.103.017772. Epub 2003 May 14. | |
| 19684043 | Result | Devroey P, Boostanfar R, Koper NP, Mannaerts BM, Ijzerman-Boon PC, Fauser BC; ENGAGE Investigators. A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol. Hum Reprod. 2009 Dec;24(12):3063-72. doi: 10.1093/humrep/dep291. Epub 2009 Aug 14. |
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The PI will collect individual data which will later be analyzed. Only analyzed overall data will be shared.
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Enrolled patients all had to comply with the entry criteria and were all assiged to the "study group". The "control group" subjects were selected restrospectively by also complying with the criteria and with similar characteristics (such as AMH level, BMI, age) to the "study group" ones.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group. Corifollitropin Alfa: 150 micrograms per dose |
| FG001 | Control Group | Patients to carry out a conventional double ovarian stimulation and to receive daily injections of gonadotropins. Retrospective group (data retrieved from strictly selected treatments carried out in our institution within the 24 months prior to the inclusion of the first patient in the study group and according to the standard guideline of the clinic). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group. Corifollitropin Alfa: 150 micrograms per dose |
| BG001 | Control Group |
| 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 | Total Number of Retrieved Oocytes | To investigate the total number of oocytes retrieved through ovarian stimulation in double ovarian stimulation cycles (DUOSTIM) utilizing weekly subcutaneous injections of Corifollitropin alfa (study group) vs. daily injections of gonadotropins (control group). | Posted | Mean | Standard Deviation | oocytes | Through study completion, an average of four weeks |
|
45 days. From the start of ovarian stimulation to one week after the second oocyte retrieval in the DUOSTIM cycle.
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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 | Study Group | Patients to carry out an experimental double ovarian stimulation and to receive 4 weekly injections of Corifollitropin alfa. Prospective group. Corifollitropin Alfa: 150 micrograms per dose |
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The limitations of the present study correspond to the comparative with historical records and not blinding the patients. in addition, the study does not evaluate data on oocyte quality beyond fertilization.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Juan Carlos Castillo | Instituto Bernabeu | +34965154000 | jcastillo@institutobernabeu.com |
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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 | May 7, 2022 | May 1, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C437186 | follicle stimulating hormone, human, with HCG C-terminal peptide |
| C571801 | follitropin alfa |
| D050477 | Urofollitropin |
| ID | Term |
|---|---|
| D008596 | Menotropins |
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
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| Follitropin Alfa | Drug | Variable dose. |
|
|
| Follitropin Alfa Biosimilar | Drug | Variable dose. |
|
|
| Urinary Human follicle stimulating hormone | Drug | Variable dose. |
|
|
| Through study completion, an average of four months |
| 25444501 | Result | Kuang Y, Chen Q, Hong Q, Lyu Q, Ai A, Fu Y, Shoham Z. Double stimulations during the follicular and luteal phases of poor responders in IVF/ICSI programmes (Shanghai protocol). Reprod Biomed Online. 2014 Dec;29(6):684-91. doi: 10.1016/j.rbmo.2014.08.009. Epub 2014 Sep 6. |
| 24161646 | Result | Kuang Y, Hong Q, Chen Q, Lyu Q, Ai A, Fu Y, Shoham Z. Luteal-phase ovarian stimulation is feasible for producing competent oocytes in women undergoing in vitro fertilization/intracytoplasmic sperm injection treatment, with optimal pregnancy outcomes in frozen-thawed embryo transfer cycles. Fertil Steril. 2014 Jan;101(1):105-11. doi: 10.1016/j.fertnstert.2013.09.007. Epub 2013 Oct 23. |
| 32338123 | Result | Vaiarelli A, Cimadomo D, Petriglia C, Conforti A, Alviggi C, Ubaldi N, Ledda S, Ferrero S, Rienzi L, Ubaldi FM. DuoStim - a reproducible strategy to obtain more oocytes and competent embryos in a short time-frame aimed at fertility preservation and IVF purposes. A systematic review. Ups J Med Sci. 2020 May;125(2):121-130. doi: 10.1080/03009734.2020.1734694. Epub 2020 Apr 25. |
| 29963011 | Result | Vaiarelli A, Cimadomo D, Trabucco E, Vallefuoco R, Buffo L, Dusi L, Fiorini F, Barnocchi N, Bulletti FM, Rienzi L, Ubaldi FM. Double Stimulation in the Same Ovarian Cycle (DuoStim) to Maximize the Number of Oocytes Retrieved From Poor Prognosis Patients: A Multicenter Experience and SWOT Analysis. Front Endocrinol (Lausanne). 2018 Jun 14;9:317. doi: 10.3389/fendo.2018.00317. eCollection 2018. |
| 38983736 | Derived | Castillo JC, Fuentes A, Ortiz JA, Abellan E, Bernabeu A, Bernabeu R. Continuous ovarian stimulation: a proof-of-concept study exploring the uninterrupted use of corifollitropin alpha in DuoStim cycles for enhanced efficiency and patient convenience (Alicante protocol). F S Rep. 2024 Mar 28;5(2):176-182. doi: 10.1016/j.xfre.2024.03.005. eCollection 2024 Jun. |
Patients to carry out a conventional double ovarian stimulation and to receive daily injections of gonadotropins. Retrospective group (data retrieved from strictly selected treatments carried out in our institution within the 24 months prior to the inclusion of the first patient in the study group and according to the standard guideline of the clinic).
Follitropin Alfa: Variable dose.
Follitropin Alfa Biosimilar: Variable dose.
Urinary Human follicle stimulating hormone: Variable dose.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Number of MII Oocytes | To compare the total number of MII oocytes obtained in double stimulation cycles in study vs control groups | Posted | Mean | Standard Deviation | oocytes | Through study completion, an average of four months |
|
|
|
| Secondary | Duration of Ovarian Stimulation | Total days of follicular and luteal phases | Posted | Mean | Standard Deviation | days | Through study completion, an average of four months |
|
|
|
| Secondary | Number of Injections | Number of injections during the DUOSTIM cycle | Posted | Mean | Standard Deviation | injections | Through study completion, an average of four months |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Control Group | Patients to carry out a conventional double ovarian stimulation and to receive daily injections of gonadotropins. Retrospective group (data retrieved from strictly selected treatments carried out in our institution within the 24 months prior to the inclusion of the first patient in the study group and according to the standard guideline of the clinic). | 0 | 15 | 0 | 15 | 0 | 15 |
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| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |