APHRODITE GroupGTIHNONCT07540611
Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive
A study testing hCG + FSH therapy in people with APHRODITE Group, run by Indira IVF Hospital Pvt Ltd at 8 sites in India.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- APHRODITE Group
- What is being tested?
- hCG + FSH therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 860 participants
- Where
- 8 sitesIndia
- Study dates
- 17 Jul 2026to 17 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
India8 sites
Recruitment
Allahābād, Uttar Pradesh
Anjali Gahlan, MS
Recruitment
Bangalore, Karnataka, 560041
Shyam Gupta, MD, 9899984791, centerhead.bangalore@indiraivf.in
Recruitment
Bhāndup, Maharashtra
Rinoy Shreedharan, MD, +917874071247
Recruitment
Delhi, National Capital Territory of Delhi
Recruitment
Jaipur, Rajasthan
Tanu Batra, MD, 09567971239, ifa@indiraivf.in
Recruitment
Lucknow, Uttar Pradesh
Pawan Yadav, MD
Recruitment
Patna, Bihar, 800014
Dayaniddhi Kumar, Ph D, 9011803606
Recruitment
Pune, Maharashtra
Amol Lunkad, MD
About this study
Official title: "Gonadotropin Therapy in Idiopathic Hypogonadal Non-Obstructive Azoospermia (APHRODITE Groups 3-4): A Multicenter Randomized Controlled Trial"
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?
Read more
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
- Conditions
- APHRODITE Group
- Being tested
- No intervention, hCG + FSH therapy
- Keywords
- Non-obstructive azoospermia (NOA), Idiopathic NOA, Male infertility, Hypogonadism
- Medical subject headings
- Infertility, Male, Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Standard of Care
hCG + FSH therapyOther
hCG + FSH therapy with monthly hormone-driven titration (hCG initial ~83 µg SC twice weekly; no preset min/max; target TT >350-900 ng/dL) + FSH 150 IU SC twice weekly (increase to 150 IU SC three times weekly if 'FSH reset' <1.5 IU/L); allow anastrozole 1 mg PO daily /letrozole 2.5 mg half tablet alternate day if T/E <10
| Study group | Role | What they receive |
|---|---|---|
| hCG + FSH therapy | Experimental | Not described Receives: Other: hCG + FSH therapy |
| Standard of Care | Active comparator | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success or Sperm Availability
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.
Measured: from randomization through Week 16 via ejaculate or micro-TESE
Secondary outcomes (10)
Micro-TESE Sperm Retrieval Rate (SSR)
Whether sperm are retrieved during micro-TESE
Measured: 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-
Need for Micro-TESE Surgery
Whether the participant requires micro-TESE
Measured: Up to Week 16
Safety / Harms
All adverse events (AE/SAE) related to treatment or procedure
Measured: Week 16
ICSI Fertilization Rate
% of injected oocytes that form normal 2PN embryos
Measured: Within the ICSI cycle ≈ Day 1-3 after ICSI
Blastulation Rate
% of embryos reaching blastocyst stage
Measured: Day 5-7 after fertilization
Blastocyst Quality
Grading of blastocysts based on standard morphology criteria
Measured: Day 5-7 after fertilization
Top-Quality Blastocyst Rate
% of "top-1 quality" blastocysts formed
Measured: Day 5-7 after fertilization
Clinical Pregnancy Rate
Presence of gestational sac with cardiac activity on ultrasound
Measured: ≈ 6-8 weeks after embryo transfer
Miscarriage Rate
Pregnancy loss before 20 weeks
Measured: From pregnancy confirmation to 20 weeks gestation
Live Birth
Delivery of a live infant
Measured: Up to delivery (~9 months after embryo transfer)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start17 Jul 2026 (estimated)
- Primary completion16 Jan 2027 (estimated)
- Study completion17 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for APHRODITE GroupStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indira IVF Hospital Pvt Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Vipin Chandra, Indira IVF Hospital Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540611
- Sponsor's protocol ID
- IIHL-UDR-P-002-2025
- Other IDs
- IIHL-UDR-P-002-2025
- Acronym
- GTIHNO
- Status last verified
- Apr 2026
- First submitted
- 3 Feb 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will be shared on request
Publications
Esteves SC, Yarali H, Vuong LN, Carvalho JF, Ozbek IY, Polat M, Le HL, Pham TD, Ho TM. Low Prognosis by the POSEIDON Criteria in Women Undergoing Assisted Reproductive Technology: A Multicenter and Multinational Prevalence Study of Over 13,000 Patients. Front Endocrinol (Lausanne). 2021 Mar 12;12:630550. doi: 10.3389/fendo.2021.630550. eCollection 2021.
PubMed 33790862Esteves SC, Humaidan P, Ubaldi FM, Alviggi C, Antonio L, Barratt CLR, Behre HM, Jorgensen N, Pacey AA, Simoni M, Santi D. APHRODITE criteria: addressing male patients with hypogonadism and/or infertility owing to altered idiopathic testicular function. Reprod Biomed Online. 2024 Apr;48(4):103647. doi: 10.1016/j.rbmo.2023.103647. Epub 2023 Oct 29.
PubMed 38367592Chandra V, Esteves SC, Sanagoudar S. Gonadotropin therapy in idiopathic hypogonadal non-obstructive azoospermia (APHRODITE Groups 3-4): a multicenter randomized controlled trial. Front Reprod Health. 2026 Jul 9;8:1867412. doi: 10.3389/frph.2026.1867412. eCollection 2026.
PubMed 42495163