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Предстои набиране Не е приложимо NCT07540611

Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive

Не е приложима фаза (напр. обсервационно)
Заболявания: APHRODITE Group

Спонсор: Indira IVF Hospital Pvt Ltd

Налично на: БГ
Обобщение
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
Кой може да участва
Inclusion Criteria: \- 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). Exclusion Criteria: 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
Интервенции
No intervention
OTHER
hCG + FSH therapy
OTHER
Места на провеждане 8
Индия (8)
Recruitment
Allahābād , Uttar Pradesh
Recruitment
Bangalore , Karnataka
Recruitment
Bhāndup , Maharashtra
Rinoy Shreedharan, MD
Recruitment
Delhi , National Capital Territory of Delhi
Recruitment
Jaipur , Rajasthan
Recruitment
Lucknow , Uttar Pradesh
Recruitment
Patna , Bihar
Dayaniddhi Kumar, Ph D
Recruitment
Pune , Maharashtra
Технически детайли
Статус
Предстои набиране
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Само мъже
Здрави доброволци
Не
Начална дата
17.07.2026
Крайна дата
17.07.2027
Регистрационен номер
NCT07540611
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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