"Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive Azoospermia (APHRODITE Groups 3-4): A Multicenter Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 860
- 试验地点
- 8
- 主要终点
- Success or Sperm Availability
研究概览
简要总结
The goal of this clinical trial is to determine whether short-term gonadotropin therapy (hCG + FSH) can increase sperm availability for ICSI in men with idiopathic non-obstructive azoospermia (NOA) and hypogonadism. The main questions it aims to answer are:
Does hormonal optimization improve the likelihood of obtaining usable sperm (via ejaculate or micro-TESE) by Week 16? Does hormonal therapy reduce the need for micro-TESE or improve downstream embryological and clinical outcomes?
Because there is a comparison group, researchers will compare hCG + FSH hormonal therapy with standard-of-care (no gonadotropins) to see if hormonal optimization increases sperm retrieval success and decreases surgical reliance.
Participants will:
Undergo baseline hormonal and semen testing Be randomized to either hormonal therapy or standard-of-care If in the hormonal arm: receive hCG and FSH with monthly dose titration and aromatase inhibitors if indicated Provide semen samples at Weeks 12 and 16 Undergo micro-TESE if no ejaculated sperm are found (timing per protocol) Complete safety assessments and follow-up through Week 16
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
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •- Idiopathic NOA; hypogonadal (TT <350 ng/dL on two fasting morning tests); FSH ≥7.6 IU/L (APHRODITE Group 3: 7.6-12.0 IU/L; Group 4: >12.0 IU/L).
排除标准
- •cryptorchidism, chemo/radiation, genetic NOA (e.g., AZFa/complete AZFb), testicular trauma/torsion, post-orchitis. prior micro-TESE within 12 months; recent gonadotropin therapy (<6 months); uncontrolled endocrine disease; active malignancy; severe liver disease; polycythemia (Hct>50%); inability to comply. Varicocele>= Grade 3
研究组 & 干预措施
Standard of Care
干预措施: No intervention (Other)
hCG + FSH therapy
干预措施: hCG + FSH therapy (Other)
结局指标
主要结局
Success or Sperm Availability
时间窗: from randomization through Week 16 via ejaculate or micro-TESE
Sperm Availability for ICSI was defined as the presence of viable sperm suitable for intracytoplasmic sperm injection (ICSI) at any time from randomization through Week 16. Sperm could be obtained either through ejaculate or via microsurgical testicular sperm extraction (micro-TESE). Assessment of sperm availability was performed by a centralized adjudication committee, which was blinded to treatment allocation to ensure objective and unbiased evaluation.
次要结局
- Need for Micro-TESE Surgery(Up to Week 16)
- Safety / Harms(Week 16)
- Micro-TESE Sperm Retrieval Rate (SSR)(The Micro-TESE Sperm Retrieval Rate (SSR) was assessed during the period from randomization through Week 16. The outcome was determined based on the availability of at least one viable sperm retrieved via microsurgical testicular sperm extraction (micro-)
- ICSI Fertilization Rate(Within the ICSI cycle ≈ Day 1-3 after ICSI)
- Blastulation Rate(Day 5-7 after fertilization)
- Blastocyst Quality(Day 5-7 after fertilization)
- Top-Quality Blastocyst Rate(Day 5-7 after fertilization)
- Clinical Pregnancy Rate(≈ 6-8 weeks after embryo transfer)
- Miscarriage Rate(From pregnancy confirmation to 20 weeks gestation)
- Live Birth(Up to delivery (~9 months after embryo transfer))
研究者
Dr Vipin Chandra
Chief Clinical Lab Operations
Indira IVF Hospital Pvt Ltd