이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

비료 시험 관내 연구 및 시험 (FIRST)

2026년 10월 6일 업데이트: Gameto, Inc.

III 상 무작위 대조 시험에서 비료의 안전성과 효능을 조사하기 위해, 약물의 시험 관내 성숙 (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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

500

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

여성

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
생물학적: Fertilo

Fertilo is an engineered line of ovarian support cells that aid egg maturation.
활성 비교기: 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.
장치: Medicult IVM

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Demonstration of the superiority of Fertilo compared to the currently approved MediCult IVM® for infertility treatment via IVF procedures.
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Metaphase II (MII) Formation
기간: 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
기간: 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
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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.
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Gameto, Inc.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 4월 17일

기본 완료 (추정된)

2027년 5월 1일

연구 완료 (추정된)

2028년 1월 1일

연구 등록 날짜

최초 제출

2025년 2월 27일

QC 기준을 충족하는 최초 제출

2025년 2월 27일

처음 게시됨 (실제)

2025년 3월 5일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 6일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • GAM-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

Beginning 3 months and ending 5 years following article publication.

IPD 공유 액세스 기준

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

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다