Evaluation of the Efficacy of Annexin Columns (MACS) in Patients With Altered Sperm FISH Undergoing Assisted Reproductive Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Euploid embryo rate
研究概览
简要总结
250 petitions for FISH of spermatozoa were requested, determining the total and particular incidence in each of the indications collected. The effect of annexin columns was evaluated in 10 couples with altered FISH. In each of the couples, oocytes were pseudo-randomised to the control group and MACS®. All couples received experimental treatment. Mixed logistic regression model were adjusted to evaluate the effect of MACS® on the response variables studied.
详细描述
Prospective pseudo-randomised study carried out in the reproduction unit of the Hospital General Universitario Dr. Balmis in Alicante. The study was divided into two phases, with both being conducted in parallel. The research was approved by the Ethics Committee for Research on Medicines (CEIm) of the Alicante Department of Health. The treatment and use of the clinical data required for this study complied with current legislation, preserving the anonymity of the patients.
Phase I. A total of 250 sperm FISH tests were requested for different indications in men aged 18-55 years with normal karyotype. Of the total number of tests requested, 16 could not be performed due to low sperm count. Finally, 234 samples were analysed, of which 20 had altered sperm FISH.
Phase II. From the previous phase, not all patients with an altered FISH test were included in the second phase of the study, some of them were lost for different reasons (n=10). A total of 10 couples with no previous children in common, negative serology and normal karyotype were included. Females were aged less than 40 years and males less than 50 years at the time of treatment.
The semen sample of each couple was capacitated by density gradient centrifugation (DGC) and swim up, forming the control group. An aliquot was taken that was destined to pass through the annexin columns (MACS® ART, Miltenyl Biotic GmbH, Germany) constituting the study group. The oocytes obtained in each of the couples were pseudo-randomized and inseminated by ICSI with sperm from the study group and the control group. All couples benefited from the experimental treatment since they had the opportunity to inseminate their oocytes with sperm from both groups, thus excluding treatment bias or asymmetry.
To evaluate the efficacy of MACS® on laboratory outcome, fertilization rates, abnormal fertilization, biopsiable embryos and euploid embryos were compared between the study and control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Access to the data was restricted to the study investigators, health authorities and ISABIAL advisory bodies, when necessary, to check the study data and procedures, but always maintaining confidentiality.
The data collected for the study was identified by a code, so that no information that could identify the participants was included, and only the researchers were able to link the anonymized data to the clinical history.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women between 18 and 40 years of age. Men between 18 and 55 years of age.
- •Couples without any common, previous and healthy children.
- •Couples with indication of IVF-ICSI cycle with Preimplantation Genetic Test for Aneuploidy (PGT-A).
- •Men with altered sperm FISH results.
排除标准
- •Prior voluntary sterilization.
- •Existence of documented medical contraindication for infertility treatment.
- •Existence of documented medical contraindication to pregnancy.
- •Existence of a documented medical situation that seriously interferes with the development of the offspring.
- •Impossibility to comply with the treatment for health-related reasons or other family or social environment-related reasons.
- •Existence of a documented situation referring to any other circumstance that may seriously interfere with the development of the offspring submitted for consideration to a health care ethics committee or similar body.
- •One or both partners with positive serology for HIV, HBV and VDRL.
- •One or both partners with partner with altered karyotype.
结局指标
主要结局
Euploid embryo rate
时间窗: This variable was taken 2 days after obtaining the genetic result of the embryo biopsy.
Embryos without chromosomal alterations in relation to the total number of those that were informative.
次要结局
- Fertilization rate(This variable was taken 17-20 hours after oocyte insemination.)
- Biopsiable embryo rate(This variable was taken on the 3rd day of embryonic development, at the time of the embryo biopsy. .)
研究者
Borja Tejero Llinares
Biologist
Instituto de Investigación Sanitaria y Biomédica de Alicante