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Aspire In Vitro Maturation Study (AIM)

2026年8月26日 更新者:Inception Fertility Research Institute, LLC

Pilot Study Assessing the Feasibility of CAPA-IVM in Participants With Good Ovarian Reserve

A study to assess the Capacitation - in-vitro maturation (CAPA-IVM) system as an option for patients with a good ovarian reserve to achieve pregnancy.

研究概览

详细说明

CAPA-IVM is being evaluated for its feasibility as an In vitro maturation (IVM) system in US fertility clinics. IVM is a laboratory process for maturing immature oocytes (eggs) outside of the body after egg retrieval. Egg retrievals are performed without prior ovarian stimulation.

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Texas
      • Houston、Texas、美国、77030
        • Aspire Fertility Houston

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Signed Informed Consent Form to participate in this study voluntarily.
  2. Age 18-37 years at the time of starting the CAPA-IVM cycle.
  3. Body mass index (BMI) ≤38 kg/m2.
  4. Serum AMH levels greater than or equal to 3.5 ng/mL.
  5. Have an indication for IVM/IVF cycle.
  6. Have not received more than two previous treatments of IVM/IVF.
  7. Willing and able to comply with trial procedures, including oocyte pick-up from small follicles and to follow a CAPA-IVM cycle.
  8. Agree to culture all embryos to blastocyst stage, vitrify suitable blastocysts, and submit suitable blastocysts for PGT-A according to clinic protocol before determining transfer eligibility.
  9. Agree that only euploid CAPA-IVM-derived blastocysts will be eligible for transfer and that a single euploid blastocyst will be transferred per programmed FET cycle, unless a protocol-defined exception is prospectively justified by the investigator.

Exclusion Criteria:

  1. Prior ovarian surgery.
  2. Known uterine abnormalities (adenomyosis, leiomyoma (≥5 cm), bicornuate uterus, intrauterine adhesion) that would compromise successful pregnancy or live birth.
  3. Had received ovarian stimulation within the last 3 months for ovulation induction or IVF
  4. Had evidence of a very low oocyte maturation rate (oocyte maturation rate < 50% in any previous IVF or IVM cycle).
  5. For male partners: severe oligoasthenoteratozoospermia, requirement for retrograde ejaculation procedures or surgical sperm retrievals. Donor sperm is permitted.
  6. Known chromosomal abnormalities in participant or partner.
  7. Have herself or partner with acute urinary tract infection or sexually transmitted diseases.
  8. Have herself or partner a severe mental disorder, such as schizophrenia, bipolar affective disorder, or intellectual disability caused by mental disorders.
  9. Have a history of recurrent pregnancy loss defined as two or more clinical pregnancies without live birth.
  10. Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus that would preclude to conduct a CAPA-IVM cycle without ovarian stimulation or participation in this study.
  11. Any known clinically significant systemic disease (heart, liver, kidney or other organs) that would prevent or compromise pregnancy or participation in this study.
  12. Pregnancy or contraindication to pregnancy.
  13. Undiagnosed vaginal bleeding.
  14. Known drug or alcohol abuse or dependency for the participant or partner for the last 12 months.
  15. Current or past (3 months) smoking habit of 10 or more cigarettes per day.
  16. Had a recent exposure to teratogenic radiation, drugs or toxins which could still be active during the study period.
  17. Currently participating in another clinical trial or receiving an investigational medicinal product.
  18. Previous participation in this study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:CAPA-IVM
Patients will undergo egg retrieval prior to in vitro maturation with CAPA-IVM system and subsequent frozen embryo transfer.
CAPA-IVM is a two-step IVM process to mature oocytes in the laboratory after egg retrieval.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Metaphase II rate
大体时间:Assessed approximately 40 hours after egg retrieval
The metaphase II (MII) rate is defined as the number of oocytes that reach MII stage of development divided by the number of cumulus-oocyte-complexes (COCs) placed into CAPA-IVM culture.
Assessed approximately 40 hours after egg retrieval

次要结果测量

结果测量
措施说明
大体时间
Number of MII oocytes
大体时间:Assessed approximately 40 hours post egg retrieval
The number of oocytes that reach the metaphase II (MII) stage of development after CAPA-IVM culture
Assessed approximately 40 hours post egg retrieval
Fertilization rate
大体时间:Assessed 16-18 hours post fertilization
The fertilization rate is defined as the number of embryos that have 2 pro-nuclei post fertilization by intracytoplasmic sperm injection (ICSI)
Assessed 16-18 hours post fertilization
Number of blastocysts
大体时间:Assessed 5-7 days post fertilization
The number of embryos that make it to the blastocyst stage of development post fertilization
Assessed 5-7 days post fertilization
Number of blastocysts vitrified
大体时间:Assessed 5-7 days post fertilization
The number of embryos that are cryopreserved by vitrification post fertilization
Assessed 5-7 days post fertilization
Number of blastocysts submitted for PGT-A
大体时间:Assessed 5-7 days post fertilization
The number of embryos that are biopsied and samples sent for PGT-A testing
Assessed 5-7 days post fertilization
Number of euploid blastocysts
大体时间:Assessed 2-4 weeks post embryo biopsy
Number of embryos that had a euploid result from PGT-A testing
Assessed 2-4 weeks post embryo biopsy
Positive beta-hCG rate
大体时间:Assessed 9-11 days post embryo transfer
The number of patients with a serum QHCG level greater than 5 after embryo transfer divided by the total number of embryo transfers
Assessed 9-11 days post embryo transfer
Ongoing pregnancy rate
大体时间:Assessed approximately 10 weeks post embryo transfer
The number of patients who have an ongoing intrauterine pregnancy at the last study visit
Assessed approximately 10 weeks post embryo transfer
Live birth rate
大体时间:Assessed approximately 40 weeks post embryo transfer
Number of patients who had a live birth after embryo transfer
Assessed approximately 40 weeks post embryo transfer

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月26日

初级完成 (估计的)

2028年2月1日

研究完成 (估计的)

2028年2月1日

研究注册日期

首次提交

2026年8月20日

首先提交符合 QC 标准的

2026年8月26日

首次发布 (实际的)

2026年8月27日

研究记录更新

最后更新发布 (实际的)

2026年8月27日

上次提交的符合 QC 标准的更新

2026年8月26日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • IRI-ASP-2026-02

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

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