Studio e sperimentazione di ricerca in vitro di fertilo (FIRST)
Studio di controllo randomizzato di fase III per studiare la sicurezza e l'efficacia del fertilo contro la maturazione in vitro mediculta (IVM)
The goal of this clinical trial is to evaluate the safety and efficacy of using Fertilo for In vitro maturation (IVM) in participants 18-35 years of age. The main question it aims to answer is whether the use of Fertilo is superior to using Medicult IVM for In vitro maturation.
Researchers will compare the number of ongoing pregnancies at 12 weeks gestation for participants in each arm.
- Arm 1 participants will have all cumulus oocyte complexes (COCs), or eggs surrounded by helper cells, cultured in Fertilo for 30 hours.
- Arm 2 participants will have all cumulus oocyte complexes (COCs), or eggs surrounded by helper cells, cultured in Medicult IVM for 30 hours.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Fase 3
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Clinical Trials
- Numero di telefono: 512-535-1164
- Email: clinicaltrials@gametogen.com
Luoghi di studio
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California
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Clovis, California, Stati Uniti, 93611
- Reclutamento
- Women's Specialty & Fertility Center
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Contatto:
- Casey Study Coordinator
- Numero di telefono: 559-299-7700
- Email: cstorm@santehealth.net
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Investigatore principale:
- Howard Synn, MD
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Encino, California, Stati Uniti, 91436
- Reclutamento
- HRC Fertility
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Investigatore principale:
- Robert Boostanfar, MD
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Contatto:
- Shanise Ashiem
- Numero di telefono: 818-788-7288
- Email: clinicaltrialsENC@havingbabies.com
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Florida
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Clearwater, Florida, Stati Uniti, 33759
- Reclutamento
- Florida Fertility Institute
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Contatto:
- Gayle Cameron
- Numero di telefono: 727-724-9730
- Email: gaylec@xxresearch.com
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Investigatore principale:
- Mark Sanchez, MD
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Pembroke Pines, Florida, Stati Uniti, 33026
- Reclutamento
- IVF Florida
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Contatto:
- Karina Stroker
- Numero di telefono: 62518 954-247-6200
- Email: karina.stroker@usfertility.com
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Investigatore principale:
- Luis Hoyos, MD
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Maryland
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Rockville, Maryland, Stati Uniti, 20850
- Reclutamento
- Shady Grove Fertility
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Investigatore principale:
- Kate Devine, MD
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Contatto:
- Joshua McKeeby
- Numero di telefono: 301-545-1423
- Email: sgfclinicalresearchteam@sgfertility.com
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New York
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New York, New York, Stati Uniti, 10019
- Reclutamento
- Columbia University Fertility Center
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Contatto:
- Stephanie Morgan
- Numero di telefono: 212-314-8837
- Email: sm3415@cumc.columbia.edu
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Investigatore principale:
- Eric Forman, MD
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28207
- Reclutamento
- Reach Fertility
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Contatto:
- Stephanie Graham, MS
- Numero di telefono: 704-343-4455
- Email: Stephanie.Graham@northcarolinafertility.com
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Investigatore principale:
- Jack Crain, MD
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Raleigh, North Carolina, Stati Uniti, 27607
- Reclutamento
- Conceptions Fertility
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Investigatore principale:
- John Park, MD
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Contatto:
- Sofia Sequeira
- Numero di telefono: 919-782-5911
- Email: ccresearch@carolinaconceptions.com
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Texas
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Addison, Texas, Stati Uniti, 75001
- Reclutamento
- Aspire Fertility Dallas
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Investigatore principale:
- Christine Mansfield, MD
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Contatto:
- Alexis Denson
- Numero di telefono: 214-414-3806
- Email: Research@inceptionllc.com
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Austin, Texas, Stati Uniti, 78705
- Reclutamento
- Aspire Fertility Austin
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Investigatore principale:
- Angela Kelley, MD
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Contatto:
- Laurel Schultz
- Numero di telefono: 512-479-7979
- Email: Research@inceptionllc.com
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Bedford, Texas, Stati Uniti, 76022
- Reclutamento
- Care Fertility
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Investigatore principale:
- Kevin Doody, MD
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Contatto:
- Michelle Evans
- Numero di telefono: 1033 817-540-7070
- Email: michellee@embryo.net
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Contatto:
- Charlene Nwajei
- Email: charlenen@embryo.net
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Dallas, Texas, Stati Uniti, 75231
- Reclutamento
- Dallas Fort Worth Fertility Associates
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Contatto:
- Jenny Patel
- Numero di telefono: 214-363-5965
- Email: thirdparty@dallasfertility.com
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Investigatore principale:
- Samuel Chantilis, MD
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San Antonio, Texas, Stati Uniti, 78528
- Reclutamento
- Aspire Fertility San Antonio
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Investigatore principale:
- Jennifer Knudtson, MD
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Contatto:
- Laurel Anderson
- Numero di telefono: 210-337-8453
- Email: Research@inceptionllc.com
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San Antonio, Texas, Stati Uniti, 78249
- Reclutamento
- Pozitivf Fertility San Antonio
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Contatto:
- Jose Acevedo
- Numero di telefono: 3046 210-404-2229
- Email: jose.acevedo@pozitivf.com
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Investigatore principale:
- Francisco Arredondo, MD
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Webster, Texas, Stati Uniti, 77598
- Reclutamento
- Shady Grove Houston
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Contatto:
- Cara Barrier, RN
- Numero di telefono: 832-342-9129
- Email: cara.barrier@sgfertility.com
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Contatto:
- Maryanne Fisher, RN
- Numero di telefono: 281-557-3084
- Email: maryanne.fisher@sgfertility.com
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Investigatore principale:
- Vicki Schnell, MD
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Utah
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Pleasant Grove, Utah, Stati Uniti, 84062
- Reclutamento
- Utah Fertility Center
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Contatto:
- Coral Halterman, RN
- Numero di telefono: 7036 801-785-5100
- Email: coral.halterman@utahfertility.com
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Investigatore principale:
- Shawn Gurtcheff, MD
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Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Written informed consent.
- Premenopausal, Age 18-35.
- Body mass index (BMI) 21-40.
- Candidate for IVF according to the ASRM definition (infertile for ≥12 months, require the use of donor sperm, or the inability to achieve a successful pregnancy based on a patient's medical, sexual, and reproductive history, age, physical findings, diagnostic testing, or any combination of those factors).
- No contraindications to the use of oral contraceptive pills (OCP) or gonadotropins.
- Plan to use embryos for transfer within 2 months of blastocyst cryopreservation.
- Anti-mullerian hormone (AMH) ≥ 3 ng/mL within 6 months of Screening/Visit 1 or assessed at the screening visit.
- Normal uterine cavity as assessed by hysteroscopy, hysterosalpingography or sonohysterography within 12 months of Screening/Visit 1 or assessed at the screening visit.
- Having adequate visualization of both ovaries, without evidence of significant abnormality/pathology or major cyst documented by transvaginal ultrasound within 3 months of screening or assessed during screening period.
- No endometriosis of American Fertility Society (AFS) grade 3 or 4 or presence of endometrioma.
- Minimum of 1 month without treatment with either clomiphene citrate, GnRH agonist or gonadotropins prior to start of ovarian stimulation.
- Have a male partner with semen analysis within the past 12 months prior to randomization considered adequate to proceed with intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If this criterion is not met, the subject can only be entered if donor sperm will be used.
Exclusion Criteria:
- History of recurrent pregnancy loss (defined as >2 clinical pregnancies without live birth).
- Baseline prolactin levels greater than 30 ng/ml
- Male: requirement for retrograde ejaculation procedures or surgical sperm retrievals.
- Any clinically relevant pathology that in the judgment of the investigator could impair embryo implantation or pregnancy continuation.
- Use of preimplantation genetic testing (PGT) of oocytes, embryos, or transferred blastocysts during participation in the study.
- Use of donated oocytes, embryos or blastocysts for this treatment cycle while participating in the study or use of oocytes, embryos, or blastocysts from a previous treatment cycle.
- Participation in a concurrent clinical trial or in another investigational drug trial within the past 2 months.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: Fertilo
Immature cumulus-oocyte complexes (COCs) are oocytes surrounded by cumulus cells that have not yet matured. The COCs are cultured in Fertilo coculture condition then fertilized, grown to the blastocyst stage, vitrified, and later transferred for reproductive purpose. |
Fertilo is an engineered line of ovarian support cells that aid egg maturation. |
|
Comparatore attivo: Medicult IVM®
Immature COCs are cultured in the standard IVM system MediCult IVM® then fertilized, grown to the blastocyst stage, vitrified, and later transferred for reproductive purpose. |
MediCult IVM is a system of culture media designed for the in vitro maturation of immature oocytes. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Demonstration of the superiority of Fertilo compared to the currently approved MediCult IVM® for infertility treatment via IVF procedures.
Lasso di tempo: 12 weeks gestation
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Cumulative ongoing pregnancy from cycles initiated within 6 months post-randomization. The primary endpoint of ongoing pregnancy is assessed at 12 weeks gestation or later. Cumulative ongoing pregnancy is determined using the cumulative outcome of up to the first two embryo transfers. Subjects with a detectable fetal heartbeat, considered normal and healthy, are considered as having achieved an ongoing pregnancy. "Normal" will be determined as expected for the gestational age ranging from 110 bpm to 180 bpm and measured via ultrasound. Ongoing pregnancy is recorded as either a Yes or No for normal fetal heart rate present for each of the Subject's transfer cycles. Subjects without an ongoing pregnancy assessment are considered as a No unless a later observation indicates otherwise (i.e., a live birth). Cumulative ongoing pregnancy is derived as either a Yes, if at least one of the first two embryo transfers achieves an ongoing pregnancy, or a No otherwise. |
12 weeks gestation
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Metaphase II (MII) Formation
Lasso di tempo: 30 hours post-oocyte retrieval
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MII formation rate is assessed at 30 hours post-oocyte retrieval. A Metaphase II (MII) oocyte is defined as an oocyte with a first polar body (PB1). The MII formation rate is measured as a Subject's total number of MII oocytes divided by their total number of COCs. The MII formation rate is multiplied by 100 and expressed as a percentage. |
30 hours post-oocyte retrieval
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Fertilization Rate
Lasso di tempo: 16-18 hours post-ICSI
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Fertilization rate is assessed at 16-18 hours post-ICSI. Fertilized embryos displaying 2 pronuclei and 2 polar bodies are considered normally fertilized. Fertilized embryos with no pronuclei are considered not fertilized. Fertilized embryos with one pronuclei are held to determine cleavage, as pronuclei visualization timing may mask the second pronucleus. The fertilization rate is measured as a Subject's total number of fertilized embryos divided by their total number of COCs. The fertilization rate is multiplied by 100 and expressed as a percentage. |
16-18 hours post-ICSI
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Embryo cleavage rate
Lasso di tempo: Day 3 post-ICSI
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Embryo cleavage rate is assessed at day 3 post-ICSI. Embryos with 2 or more cells are considered as cleaved. Fertilized embryos displaying a single cell will be considered not cleaved. The cell cleavage rate is measured as a Subject's total number of embryos considered as cleaved divided by their total number of COCs. The cell cleavage rate is multiplied by 100 and expressed as a percentage. |
Day 3 post-ICSI
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High quality blastocyst formation rate.
Lasso di tempo: Day 5, 6, and 7 post-ICSI
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High quality blastocyst formation rate is assessed at day 5, 6 and 7 post-ICSI. Embryos that have successfully passed the morula stage, as indicated by cavitation, will be designated as blastocysts and will be graded according to the Gardner Scale. Blastocysts having a Gardner Scale score of 3CC or higher are considered as high quality blastocysts. The high quality blastocyst formation rate is measured as a Subject's total number of high quality blastocysts divided by their total number of COCs. The high quality blastocyst formation rate is multiplied by 100 and expressed as a percentage. |
Day 5, 6, and 7 post-ICSI
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High quality vitrified blastocyst rate.
Lasso di tempo: Day 5, 6, and 7 post-ICSI
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High quality vitrified blastocyst rate is assessed at day 5, 6 and 7 post-ICSI. Embryos deemed high quality, as measured by a Gardner score of 3CC of greater, that have been vitrified, a method of rapid cryopreservation for future embryo transfer, will be designated as high quality vitrified blastocysts. The high quality vitrified blastocyst rate is measured as a Subject's total number of high quality blastocysts that are vitrified divided by their total number of COCs. The high quality vitrified blastocyst rate is multiplied by 100 and expressed as a percentage. |
Day 5, 6, and 7 post-ICSI
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Cumulative biochemical pregnancy.
Lasso di tempo: 10 to 14 days following FET
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Cumulative biochemical pregnancy from cycles initiated within 6 months post randomization. Biochemical pregnancy is assessed at 10 to 14 days following FET. Cumulative biochemical pregnancy is determined using the cumulative outcome of up to the first two embryo transfers. Subjects with BHCG value greater than 5 mIU/mL on two separate tests are considered as achieving biochemical pregnancy. Biochemical pregnancy is recorded as either a Yes or No for each of the Subject's transfer cycles. Subjects without a biochemical pregnancy assessment are considered as a No unless a later observation indicates otherwise (i.e., a clinical pregnancy, ongoing pregnancy, or live birth). Cumulative biochemical pregnancy is derived as either a Yes, if at least one of the first two embryo transfers achieves a biochemical pregnancy, or a No otherwise. |
10 to 14 days following FET
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Cumulative clinical pregnancy.
Lasso di tempo: 4-6 weeks gestation
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Cumulative clinical pregnancy from cycles initiated within 6 months post randomization is assessed at 4-6 weeks gestation. Cumulative clinical pregnancy is determined using the cumulative outcome of up to the first two embryo transfers. Subjects with a gestational sac visualized with TVU are considered as having achieved a clinical pregnancy. Clinical pregnancy is recorded as either a Yes or No for each of the Subject's transfer cycles. Subjects without a clinical pregnancy assessment are considered as a No unless a later observation indicates otherwise (i.e., an ongoing pregnancy or live birth). Cumulative clinical pregnancy is derived as either a Yes, if at least one of the first two embryo transfers achieves a clinical pregnancy, or a No otherwise. |
4-6 weeks gestation
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Cumulative live birth.
Lasso di tempo: Greater than 24 weeks gestation
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Cumulative live birth from cycles initiated within 6 months post-randomization. Live birth is confirmed at >24 weeks gestation by the presence of signs of life such as breathing, heartbeat, pulsation of the umbilical cord, or definitive movement of voluntary muscles. Cumulative live birth is determined using the cumulative outcome of up to the first two embryo transfers. Subjects with at least one neonate meeting the definition of live birth are considered as having achieved a live birth. Live birth is recorded as either a Yes or No for each of the Subject's transfer cycles. Subjects without a live birth assessment are considered as a No. Cumulative live birth is derived as either a Yes, if at least one of the first two embryo transfers achieves a live birth, or a No otherwise. |
Greater than 24 weeks gestation
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Collaboratori e investigatori
Sponsor
Sponsor
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Inizio studio (Effettivo)
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Completamento primario (Stimato)
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Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
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Maggiori informazioni
Termini relativi a questo studio
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Periodo di condivisione IPD
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Criteri di accesso alla condivisione IPD
Researchers who provide a methodologically sound proposal. Requestord will need to contact clinicaltrials@gametogen.com and sign a data access agreement.
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