Preliminary Assessment of the Impact of Melatonin Therapy for Women With Diminished Ovarian Reserve on the Ovarian Reserve and the ICSI Outcomes
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy
研究概览
简要总结
Diminished ovarian reserve (DOR) is a major challenge in female fertility, often leading to poor oocyte quality and low pregnancy rates during assisted reproduction. Melatonin is a potent antioxidant that may protect developing eggs from oxidative stress. This randomized clinical trial aims to evaluate whether a 4-week course of oral melatonin therapy before egg retrieval can improve the quality of oocytes and embryos, and ultimately increase pregnancy rates for women with DOR undergoing Intracytoplasmic Sperm Injection (ICSI). The study compares melatonin therapy against a placebo to assess its impact on follicular fluid health and clinical pregnancy success.
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)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Confirmed Diminished Ovarian Reserve (DOR) based on Bologna criteria (e.g., low AMH, low AFC).
- •Undergoing ICSI with frozen blastocyst transfer (FBT) protocol.
- •Willingness to comply with a 28-day pre-retrieval medication regimen.
排除标准
- •Severe endometriosis or hydrosalpinx.
- •Uterine anomalies (e.g., large fibroids or uterine septums).
- •Chronic systemic diseases (e.g., uncontrolled diabetes or hypertension).
- •Partner with severe male factor infertility requiring TESE/PESA (to isolate the effect on oocyte quality).
- •Current use of other antioxidant supplements.
研究组 & 干预措施
Melatonin Group
Participants receive one 3 mg Melatonin capsule orally every night for 28 consecutive days prior to the start of ovarian stimulation for ICSI.
干预措施: Melatonin capsule (Drug)
Placebo Group
Participants receive an identical-appearing placebo capsule orally every night for 28 consecutive days prior to the start of ovarian stimulation for ICSI.
干预措施: Placebo (Drug)
结局指标
主要结局
The Success Rate of Treatment Regimens in Achieving Clinical Pregnancy
时间窗: 2-3 Months
The proportion of patients who achieved a clinical pregnancy (confirmed by ultrasound visualization of a gestational sac with fetal heart activity) following frozen blastocyst transfer, reflecting the effectiveness of the administered melatonin therapy.
次要结局
未报告次要终点
研究者
Basma Sakr
Professor of Obstetrics & Gynecology, Faculty of Medicine, Benha University
Benha University