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临床试验/NCT07335016
NCT07335016尚未招募不适用

The Role of Follicular Flushing at Oocyte Retrieval

Aristotle University Of Thessaloniki2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2026年1月14日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
75
试验地点
2
主要终点
Number of oocytes retrieved

研究概览

简要总结

In vitro fertilization (IVF) is the most common method of medically assisted reproduction, involving fertilization of the egg by sperm in a lab. The process includes ovarian stimulation, oocyte retrieval, fertilization and culture, and embryo transfer. The success of IVF depends mainly on female age-as age increases, ovarian reserve and oocyte quality decrease-and the number of oocytes retrieved.

This study investigates whether follicular flushing during oocyte retrieval can increase the number of mature oocytes retrieved. This randomized study will be conducted in women undergoing ovarian stimulation with recombinant Folicullar Stimulating Hormone (FSH) and Gonadotropin-Releasing Hormone (GnRH) antagonist or Progestin Primed Ovarian Stimulation (PPOS) to suppress premature Luteinizing hormone (LH) rise. Final oocyte maturation will be triggered with recombinant Human chorionic gonadotropin (hCG) or GnRH agonist.

Eligible participants will have at least one follicle ≥11 mm in each ovary. On the day of oocyte retrieval, one ovary will be randomized to undergo follicular flushing using a single-lumen needle and the other simple aspiration, using the same needle. All fertilized oocytes from both ovaries will be cultured, seperately, to the blastocyst stage.

Study outcomes are the number of oocytes and mature oocytes retrieved, the oocyte retrieval rate, the mature oocyte retrieval rate, the maturation rate, the number of fertilized oocytes, the fertilisation rate, the number of blastocytes and the blastulation rate.

Sample size of 75 patients (25 per response category: poor, normal, high) provides 82-98% power to detect clinically meaningful interaction effects (Cohen's f=0.19-0.34) between response category and technique (follicular flushing vs. simple aspiration) under conservative assumptions of 50-70% of pilot study effects, lower correlations (ρ=0.35), and increased variability (α=0.05, two-sided, 5% attrition buffer.

详细描述

In vitro fertilization (IVF) is the most commonly applied method of medically assisted reproduction and concerns the fertilization of the egg by the sperm in a laboratory environment. The process includes the following stages: Ovarian stimulation, oocyte retrieval, fertilization and culture in the laboratory, and finally, embryo transfer.

Achieving pregnancy and live birth depends on several factors. The most important is the woman's age, as the advanced female reproductive age reduces the ovarian reserve and increases the chromosomal abnormalities of the remaining oocytes. The other important factor is the number of oocytes retrieved.

Follicular flushing aims to increase the number of mature oocytes retrieved at oocyte retrieval. The present thesis investigates the role of follicular flushing at oocyte retrieval.

The randomized study will be conducted in women undergoing ovarian stimulation with recombinant follicle-stimulating hormone (recFSH) and suppression of the premature rise of luteinizing hormone (LH) using a gonadotropin-releasing hormone (GnRH) antagonist or Progestin Primed Ovarian Stimulation (PPOS). Induction of final oocyte maturation will be done with recombinant human chorionic gonadotropin (rec hCG) or an agonist of GnRH.

Women with at least one follicle of a mean diameter of 11 millimetres or more in each ovary will be eligible to participate in the studies.

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
None

入排标准

年龄范围
18 Years 至 46 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Ovarian stimulation with recFSH and GnRH antagonist or PPOS protocol
  • Triggering final oocyte maturation with hCG or GnRH agonist
  • The day of oocyte retrieval at least one follicle of mean diameter of 11mm in each ovary
  • ICSI method of fertilisation.

排除标准

  • Presence of ovarian cyst of endometriosis
  • History of ovarian surgery
  • Monofollicular growth
  • Presence of only one ovary
  • Ovary not accessible at oocyte retrieval

研究组 & 干预措施

Follicular flushing

Active Comparator

Follicular flushing

干预措施: follicular flushing (Other)

Simple aspiration

Active Comparator

Simple aspiration

干预措施: Simple aspiration (Other)

结局指标

主要结局

Number of oocytes retrieved

时间窗: Day 0

Oocytes retrieved at oocyte retrieval are collected in the laboratory

次要结局

  • Number of mature oocytes retrieved(Day 0)
  • Oocyte retrieval rate(Day 0)
  • Mature oocyte retrieval rate(Day 0)
  • Rate of mature oocytes / total number of oocytes retrieved(Day 0)
  • Number of fertilized oocytes(Day 1)
  • Rate of fertilized oocytes / total number of mature oocytes retrieved(Day 1)
  • Number of blastocysts(Day 5 and Day 6)
  • Rate of blastocysts/total number of fertilized oocytes(Day 5 and Day 6)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

E.M. Kolibianakis

Professor in Obstetrics and Gynecology and Assisted Reproduction

Aristotle University Of Thessaloniki

研究点 (2)

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