What Should Be The Optimal Ovulation Triggering Size in Poseidon Group 4 Patients Undergoing Ovarian Stimulation?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in the Mean Mature Oocytes between two triggering strategies
研究概览
简要总结
This observational clinical study aims to determine the optimal timing of ovulation triggering in women aged 35 and above with poor ovarian reserve.
For this purpose, cases undergoing ovarian stimulation for assisted reproductive treatment and planned final oocyte triggering will be evaluated in two separate groups:
- **Experimental Group**: Final oocyte triggering will be performed when the follicle or follicles measure between 13-16 mm.
- **Control Group**: Final oocyte triggering will be performed when the follicle or follicles measure greater than 17 mm.
All triggers will be administered uniformly with 6500 units of recombinant hCG and 0,2 mg triptorelin injections.
The primary outcome of the study will be the number of mature oocytes. Secondary outcomes will include fertilization rates, embryo counts, and implantation rates.
Primary and secondary outcomes will be compared between the two groups.
详细描述
The timing of final oocyte maturation in assisted reproductive techniques is critically important. If serum steroid hormone levels are appropriate during the late follicular phase, ovulation triggering can be performed using various agents. There are numerous comparative studies in the literature on this topic.
However, a key issue is determining the most optimal timing for this trigger. In standard practice, the final triggering is performed when the follicle size reaches 17 mm or more.
The purpose of this is to obtain mature eggs from these follicles during the oocyte aspiration process.
However, in some special cases, to maximize the desired yield, this size threshold may be adjusted.
A prime example of this is in older patients with poor ovarian reserve, as the expected egg yield may not be achieved with standard practices.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 35 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age equal to or greater than 35 years
- •Women with low serum AMH (<1,2 ng/ml),
- •women with low AFC (<5)
- •women Undergoing assisted reproduction with Short antagonist protocol or long -agonist protocol
- •women who used Max daily gonadotropin dose of 300 IU
排除标准
- •Age <35 years.
- •Ovarian reserve parameters not meeting the POSEIDON group 4 definition.
- •Natural or modified natural cycles without controlled ovarian stimulation.
- •In vitro maturation (IVM) cycles.
- •Luteal-phase stimulation or DuoStim protocols.
- •Preimplantation genetic testing (PGT-A, PGT-M, or PGT-SR) cycles, unless prespecified for stratified analyses.
- •Major untreated uterine cavity pathology (e.g., submucosal fibroids, significant intrauterine adhesions, congenital uterine anomalies) or untreated hydrosalpinx.
- •Cycles with missing or incomplete follicular measurement data on the trigger day.
- •Cycles with non-standardized or undocumented trigger-to-oocyte retrieval intervals.
研究组 & 干预措施
Women defined as poor responders according to POSEIDON criteria group 4 undergoing IVF
This group of women, who have low serum AMH levels and low antral follicle count obviusly reveal unfavorable ovarian stimulation and reproductive outcomes in daily practice. Since the most important outcome measure is the live birth rate in assisted reproduction, rates have been reportedly very low for this cohort. Depending from the reports, live birth rates particularly cumulative rates directly correlated with collected numbers of oocytes. Therefore, studies should focus on this entity.
干预措施: Ovulation Trigger Timing Based on Leading Follicle Size in POSEIDON Group 4 IVF Patients (Other)
结局指标
主要结局
Change in the Mean Mature Oocytes between two triggering strategies
时间窗: From enrollment to the end of treatment at 6-8 months.
Mean numbers of oocytes, mature oocytes, fertilization rates, embryos and pregnancy rates will be compared between two different triggering sizes.
次要结局
未报告次要终点
研究者
Emre Göksan Pabuçcu
Professor
Centrum Clinic IVF Center