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临床试验/NCT03267797
NCT03267797已完成不适用

Intrauterine Administration of Autologous hCG-activated Peripheral Blood Mononuclear Cells Improves Pregnancy Outcomes in Patients With Recurrent Implantation Failure; a Double-blind Randomized Control Trial Study

SCARM Institute, Tabriz, Iran1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年10月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
pregnancy occurrence

研究概览

简要总结

Despite the many research done in the field of infertility and in vitro fertilization (IVF), more than half of the embryos transmitted in the IVF and intracytoplasmic sperm injection (ICSI) do not implant successfully. Currently, pregnancy failure following at least three IVF/ET cycle, so that one or two high-quality embryos transmitted in each cycle is defined as recurrent implantation failure (RIF). Maternal and fetal factors can be a reason for implantation failure; maternal factors include endometrial receptivity, uterine anatomic abnormalities, and immunologic factors. Implantation failure with embryonic reasons includes genetic abnormalities and any factor that affects the implantation and growth of the embryo within the uterus. In recent years, the involvement of immune-related factors mainly natural killer cells (NK), dendritic cells (DCs), macrophages (MQ), regulatory T cells (Treg) and Th-1, in the endometrial differentiation and development and endometrial receptivity, as well as induction of immunological tolerance to the fetus, have been reported.

详细描述

248 women with the history of implantation failure volunteered to receive PBMC-therapy. After immunologic consultation and doing flow cytometry analysis, 100 women with at least three IVF/ET failure who had low Th-17/Treg ratio in comparison with healthy control were enrolled in this study. These 100 patients divided randomly into two groups, 50 patients received PBMC and 50 patients as the control group received PBS. PBMCs were obtained from patients themselves five days before embryo transfer (ET) and were cultured with hCG for 48 hours. Frothy-eight hours later, PBMCs were then administered into the uterine cavity of that patient from the study group two days before ET. PBS was inseminated into the uterine cavity of the control group instead of PBMC. The concentration of inflammatory cytokines was examined in the supernatant of cultured PBMCs 2, 24 and 48 hour after incubation by ELISA. The pregnancy occurrence was confirmed 12 days after ET through positive pregnancy test (β-hCG test). The success of implantation and the occurrence of clinical pregnancy were evaluated by ultrasound through the observation of the number and the location of gestational sacs at 5-6 weeks and confirming the embryo heart pulsation.

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
Double (Participant, Outcomes Assessor)

盲法说明

The participants and the person who analyzed the results were blinded in this study. Participants were aware of the study before being randomized and informed consent was obtained from them. It should be noted that the person analyzing the results had no other role in this study.

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All patients were evaluated in accordance with the following inclusion and

排除标准

  • Inclusion Criteria:
  • Having at least three implantation failures following IVF
  • Having primary infertility
  • Age under 45 years old
  • Having regular menstrual cycles
  • BMI under 30
  • Exclusion Criteria:
  • Having polycystic ovary syndrome
  • The presence of uterine pathology;
  • Poor ovarian reserve
  • Having chromosomal abnormalities
  • Presence of auto anti-bodies such as anti-TPO, anti-TG, ACA, APA, ANA, and anti-dsDNA
  • Presence of mutations involving the coagulation system such as deficiency of factor XII, Pro C, Pro S
  • Positive HIV, HCV or HBV tests

研究组 & 干预措施

Treatment group

Experimental

Peripheral blood mononuclear cells (PBMCs) were administered into the uterine cavity of RIF patients in this group.

干预措施: Peripheral Blood Monouclear Cell (Other)

Control group

Placebo Comparator

Phosphate buffer saline (PBS) as placebo was injected into the uterine cavity of RIF patients in this group.

干预措施: Phosphate Baffer Saline (Other)

结局指标

主要结局

pregnancy occurrence

时间窗: "12 days after embryo transfer"

Laboratory tests (beta-hCG test)

examination of inflammatory cytokines (IL-1B, TNF-a and INF-Y) secretion levels in supernatant

时间窗: "48 hours after culturing"

ELISA technique

次要结局

  • Clinical pregnancy rate in patients with recurrent implantation failure (RIF)("in 5-6 weeks")
  • The live birth rate by patients with recurrent implantation failure (RIF)("After about 9 months of positive βHCG test")
  • The miscarriage rate in patients with recurrent implantation failure (RIF)("When ever during the pregnancy period (up to 9 months)")

研究者

发起方
SCARM Institute, Tabriz, Iran
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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