Follicle Activation in Patients With Poor Ovarian Response Through Fragmentation of the Ovarian Tissue.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of Metaphase II (MII)
研究概览
简要总结
This study aims to assess whether activation of primordial follicles through ovarian cortex fragmentation may increase the number of antral follicles present in the ovary of patients with diminished ovarian reserve. Secondary outcomes include number of oocytes retrieved and pregnancy rates after IVF.
Hypothesis; Evaluate whether the proposed intervention increases the pool of antral follicles (potentially stimulable ones).
详细描述
Controlled, randomized, assessor-blind clinical trial.
Thirty-six patients of La Fe University Hospital (Valencia), previously confirmed as poor responders according to the European Society of Human Reproduction and Embryology (ESHRE) criteria, will be randomized to two treatment arms:
- Arm 1 (control): no intervention.
- Arm 2 (intervention): ovarian cortex extraction by unilateral laparoscopic biopsy and ovarian tissue fragmentation in aliquots of 1 mm2. These fragments will be grafted under the ovarian cortex and meso-ovarium ipsilateraly.
Subsequently the number of antral follicles in both intervention groups will be compared and also will be the number of antral follicles in the native ovary and the grafted one in each of the patients.
Patients will receive a standard IVF treatment for poor responders according to the protocols of the assisted reproduction unit of La Fe University Hospital.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(must meet one):
- •At least two episodes of poor ovarian response (≤ 3 oocytes retrieved with a standard protocol).
- •A previous IVF cycle with ≤ 3 oocytes (following a standard stimulation protocol) and presence of an abnormal ovarian reserve test (antral follicle count of ≤ 5 or antimüllerian hormone ≤ 5pm).
排除标准
- •(must not meet any):
- •Patients under 18 or over 40 years.
- •Clinical signs of endometriosis.
- •Previous ovarian surgery.
- •Genital tract malformations.
- •Anovulatory patient (defined by the presence of irregular cycles and serum progesterone ≤ 10 ng / mL on cycle day 21).
- •Partner with severe male factor: severe oligoasthenozoospermia, oligoasthenoteratozoospermia and azoospermia.
- •All those patients who do not voluntarily give their express written consent.
结局指标
主要结局
Number of Metaphase II (MII)
时间窗: 36 hours after triggering
Number of mature MII oocytes retrieved in the IVF cycles after triggering.
次要结局
- Total Antral Follicle Count (AFC) - Initial Measure(Baseline, day 2-5 of the menstrual cycle prior to treatment)
- Final AMH Levels(Day 2-5 of the menstrual cycle 6 months after the treatment)
- Fertilization Rate(18 hours after insemination)
- Number of Cycles With Embryo Transfer (ET)(On day 3 after egg collection)
- Total Antral Follicle Count (AFC) - Final(Day 2-5 of the menstrual cycle 6 months after treatment)
- Initial Antimüllerian Hormone (AMH) Levels(Baseline, day 2-5 of the menstrual cycle prior to treatment)
- Number of Cancelled IVF Cycles(End of stimulation cycle (less than or equal to 30 days))
- Number and Percentage of Cycles With Clinical Pregnancy(6 weeks after embryo transfer)
- Live Birth Rate(9 months or birth of one or more live babies)
研究者
César Díaz García
PhD, MD
Instituto de Investigacion Sanitaria La Fe