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Étude et essai de recherche in vitro de Fertilo in vitro (FIRST)

6 octobre 2026 mis à jour par: Gameto, Inc.

Essai de contrôle randomisé de phase III pour étudier l'innocuité et l'efficacité de la maturation in vitro de Fertilo par rapport à la médicament (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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

500

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • California
      • Clovis, California, États-Unis, 93611
        • Recrutement
        • Women's Specialty & Fertility Center
        • Contact:
        • Chercheur principal:
          • Howard Synn, MD
      • Encino, California, États-Unis, 91436
        • Recrutement
        • HRC Fertility
        • Chercheur principal:
          • Robert Boostanfar, MD
        • Contact:
    • Florida
      • Clearwater, Florida, États-Unis, 33759
        • Recrutement
        • Florida Fertility Institute
        • Contact:
        • Chercheur principal:
          • Mark Sanchez, MD
      • Pembroke Pines, Florida, États-Unis, 33026
        • Recrutement
        • IVF Florida
        • Contact:
        • Chercheur principal:
          • Luis Hoyos, MD
    • Maryland
      • Rockville, Maryland, États-Unis, 20850
    • New York
      • New York, New York, États-Unis, 10019
        • Recrutement
        • Columbia University Fertility Center
        • Contact:
        • Chercheur principal:
          • Eric Forman, MD
    • North Carolina
      • Charlotte, North Carolina, États-Unis, 28207
      • Raleigh, North Carolina, États-Unis, 27607
        • Recrutement
        • Conceptions Fertility
        • Chercheur principal:
          • John Park, MD
        • Contact:
    • Texas
      • Addison, Texas, États-Unis, 75001
        • Recrutement
        • Aspire Fertility Dallas
        • Chercheur principal:
          • Christine Mansfield, MD
        • Contact:
      • Austin, Texas, États-Unis, 78705
        • Recrutement
        • Aspire Fertility Austin
        • Chercheur principal:
          • Angela Kelley, MD
        • Contact:
      • Bedford, Texas, États-Unis, 76022
        • Recrutement
        • Care Fertility
        • Chercheur principal:
          • Kevin Doody, MD
        • Contact:
        • Contact:
      • Dallas, Texas, États-Unis, 75231
        • Recrutement
        • Dallas Fort Worth Fertility Associates
        • Contact:
        • Chercheur principal:
          • Samuel Chantilis, MD
      • San Antonio, Texas, États-Unis, 78528
        • Recrutement
        • Aspire Fertility San Antonio
        • Chercheur principal:
          • Jennifer Knudtson, MD
        • Contact:
      • San Antonio, Texas, États-Unis, 78249
        • Recrutement
        • Pozitivf Fertility San Antonio
        • Contact:
        • Chercheur principal:
          • Francisco Arredondo, MD
      • Webster, Texas, États-Unis, 77598
    • Utah
      • Pleasant Grove, Utah, États-Unis, 84062
        • Recrutement
        • Utah Fertility Center
        • Contact:
        • Chercheur principal:
          • Shawn Gurtcheff, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 35 ans (Adulte)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

Inclusion Criteria:

  1. Written informed consent.
  2. Premenopausal, Age 18-35.
  3. Body mass index (BMI) 21-40.
  4. 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).
  5. No contraindications to the use of oral contraceptive pills (OCP) or gonadotropins.
  6. Plan to use embryos for transfer within 2 months of blastocyst cryopreservation.
  7. Anti-mullerian hormone (AMH) ≥ 3 ng/mL within 6 months of Screening/Visit 1 or assessed at the screening visit.
  8. Normal uterine cavity as assessed by hysteroscopy, hysterosalpingography or sonohysterography within 12 months of Screening/Visit 1 or assessed at the screening visit.
  9. 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.
  10. No endometriosis of American Fertility Society (AFS) grade 3 or 4 or presence of endometrioma.
  11. Minimum of 1 month without treatment with either clomiphene citrate, GnRH agonist or gonadotropins prior to start of ovarian stimulation.
  12. 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:

  1. History of recurrent pregnancy loss (defined as >2 clinical pregnancies without live birth).
  2. Baseline prolactin levels greater than 30 ng/ml
  3. Male: requirement for retrograde ejaculation procedures or surgical sperm retrievals.
  4. Any clinically relevant pathology that in the judgment of the investigator could impair embryo implantation or pregnancy continuation.
  5. Use of preimplantation genetic testing (PGT) of oocytes, embryos, or transferred blastocysts during participation in the study.
  6. 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.
  7. Participation in a concurrent clinical trial or in another investigational drug trial within the past 2 months.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Biologique: Fertilo

Fertilo is an engineered line of ovarian support cells that aid egg maturation.
Comparateur actif: 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.
Dispositif: Medicult IVM

MediCult IVM is a system of culture media designed for the in vitro maturation of immature oocytes.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Demonstration of the superiority of Fertilo compared to the currently approved MediCult IVM® for infertility treatment via IVF procedures.
Délai: 12 weeks gestation

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Metaphase II (MII) Formation
Délai: 30 hours post-oocyte retrieval

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
Fertilization Rate
Délai: 16-18 hours post-ICSI

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
Embryo cleavage rate
Délai: Day 3 post-ICSI

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
High quality blastocyst formation rate.
Délai: Day 5, 6, and 7 post-ICSI

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
High quality vitrified blastocyst rate.
Délai: Day 5, 6, and 7 post-ICSI

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
Cumulative biochemical pregnancy.
Délai: 10 to 14 days following FET

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
Cumulative clinical pregnancy.
Délai: 4-6 weeks gestation

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
Cumulative live birth.
Délai: Greater than 24 weeks gestation

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Gameto, Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

17 avril 2025

Achèvement primaire (Estimé)

1 mai 2027

Achèvement de l'étude (Estimé)

1 janvier 2028

Dates d'inscription aux études

Première soumission

27 février 2025

Première soumission répondant aux critères de contrôle qualité

27 février 2025

Première publication (Réel)

5 mars 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

6 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • GAM-01

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Délai de partage IPD

Beginning 3 months and ending 5 years following article publication.

Critères d'accès au partage IPD

Researchers who provide a methodologically sound proposal. Requestord will need to contact clinicaltrials@gametogen.com and sign a data access agreement.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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