Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive
Run by Indira IVF Hospital Pvt Ltd · NCT07540611 · Data updated 2026-11-12
Not yet open. This study is not taking new participants. Its registered completion date is 2027-01-16.
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…
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Men only |
| Enrollment | 860 (estimated) |
| Sponsor | Indira IVF Hospital Pvt Ltd Academic / other |
| Drugs / interventions | No intervention, hCG + FSH therapy |
| Locations | 8 sites (India) |
| Trial ID | NCT07540611 on ClinicalTrials.gov |
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Recruitment
Patna, Bihar, India -
Recruitment
Bangalore, Karnataka, India -
Recruitment
Bhāndup, Maharashtra, India -
Recruitment
Pune, Maharashtra, India -
Recruitment
Delhi, National Capital Territory of Delhi, India -
Recruitment
Jaipur, Rajasthan, India
Show 2 more locations
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Recruitment
Allahābād, Uttar Pradesh, India -
Recruitment
Lucknow, Uttar Pradesh, India
Study contacts
- Study coordinator: Vipin Chandra, DGO
- Email: drvipinchandra@indiraivf.in
- Phone: 9567971239
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.