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Disease

Infertility, Male

Late-stage therapeutic developmentEmerging researchRising momentum
MeSHInfertility, Male
4
Publications
14
Clinical trials
2025
Latest publication
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this disease.

What's happening now

An analyst briefing on current research, clinical, regulatory and industry activity surrounding this disease.

Executive briefingUpdating summary…Momentum: Low
Key developments
  • 1 clinical trial expected to report results, the earliest in Q2 2027.
Upcoming Milestones
Major developments
Upcoming trial readoutHigh impact
Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)
Results expected Q2 20272026-03-02
Major clinical milestoneImportant
Novel Treatment of Some Men With Non-Obstructive Azoospermia (NT-NOA): A Clinical Interventional Study
Primary completion2026-08-01
Clinical Milestones3View
Results expected 1
Recently completed 2
Activity timeline3

Therapeutic landscape

Therapies with a regulatory footing for this condition, alongside the wider set of agents co-studied with it in the literature.

Approved & established therapies
Follitropin betaapproved

Approval — In the female: Puregon is indicated for the treatment of female infertility in the follow… (1996)

Clinical trials

10 sponsors · 0 new · 1 completed in the last 12 months (net +0)

The current development programme across all trial phases.

Clinical programme
14
All trials
3
Active
6
Late-stage
6
Completed
Late-stage studies

Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)

Phase 3 · Recruiting · University of Miami

The Effect of Clomiphene Citrate on Sperm Parameters in Infertile Men With Idiopathic Oligoasthenozoospermia

Phase 3 · Completed · Shakeela Ishrat

Evaluation of Sperm Selection Technique Using Hyaluronic Acid Binding in Intra-cytoplasmic Sperm Injection (ICSI)

Phase 4 · Completed · ClinAmygate

To Define the Individual Need of Exogenous LH During Ovarian Stimulation for Severe LH Suppressed Patients After Administration of a GnRH Antagonist

Phase 4 · Completed · Assuta Hospital Systems

A Randomized Control Trial of the Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility

Phase 3 · Completed · Repromed

Does a GnRH Agonist Given at Embryo Transfer Improve Clinical Pregnancy and Live Birth Rates of Women Undergoing In-Vitro Fertilization?

Phase 3 · Withdrawn · Maimonides Medical Center
Recruiting

Improvement of Reproductive Function in Men With Spinal Cord Injury (SCI)

Phase 3 · Recruiting · University of Miami
Recently completed

Novel Approach for Oligospermia (NAPO): A Randomized Controlled Trial

Phase 1/2 · Completed · Martin Blomberg Jensen

The Effect of Clomiphene Citrate on Sperm Parameters in Infertile Men With Idiopathic Oligoasthenozoospermia

Phase 3 · Completed · Shakeela Ishrat

Denosumab and Male Infertility: a Randomized Controlled Double-blinded Intervention Study

Phase 2 · Completed · Martin Blomberg Jensen

Evaluation of Sperm Selection Technique Using Hyaluronic Acid Binding in Intra-cytoplasmic Sperm Injection (ICSI)

Phase 4 · Completed · ClinAmygate

To Define the Individual Need of Exogenous LH During Ovarian Stimulation for Severe LH Suppressed Patients After Administration of a GnRH Antagonist

Phase 4 · Completed · Assuta Hospital Systems

A Randomized Control Trial of the Menevit Anti-Oxidant Therapy for the Treatment of Male Infertility

Phase 3 · Completed · Repromed

Regulatory timeline

Drug regulatory events matched to this condition by indication — EMA.

First approvals
1996emaApproval — Follitropin beta· In the female: Puregon is indicated for the treatment of female infertility in the following clinical situations: anovulation (including polycystic ovarian syndrome, PCOS) in women who have been unresponsive to treatment with clomifene citrate; controlled ovarian hyperstimulation to induce the development of multiple follicles in medically assisted reproduction programs (e.g. in-vitro fertilisation / embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)). In the male: Deficient spermatogenesis due to hypogonadotrophic hypogonadism. source ↗

European Medicines Agency (CC BY 4.0). Events are matched to this condition by drug indication text — approvals/updates for drugs indicated for it, not disease-specific acts.

Research activity

4 papers

Key research shaping understanding of this disease, combining the latest publications with the most influential evidence.

Publications over time
20012025
Recent publications

The role of luteinizing hormone activity in spermatogenesis: from physiology to clinical practice.

Reproductive biology and endocrinology : RB&E · 2025 · 4 cites

Impact of stress on male fertility: role of gonadotropin inhibitory hormone.

Frontiers in endocrinology · 2023 · 32 cites

Impact of GLP-1 Agonists on Male Reproductive Health-A Narrative Review.

Medicina (Kaunas, Lithuania) · 2023 · 19 cites

Testicular dysgenesis syndrome: an increasingly common developmental disorder with environmental aspects.

Human reproduction (Oxford, England) · 2001 · 1,444 cites
Major themes7
  • Infertility, Male3
  • Environmental Exposure1
  • Glucagon-Like Peptide 11
  • Hypothalamo-Hypophyseal System1
  • Luteinizing Hormone1
  • Reproductive Health1
  • Spermatogenesis1
Leading journals4
  • Frontiers in endocrinology1
  • Human reproduction (Oxford, England)1
  • Medicina (Kaunas, Lithuania)1
  • Reproductive biology and endocrinology : RB&E1
Leading researchers8
  • Akhigbe RE1
  • Bassey GE1
  • Deebel NA1
  • Eid N1
  • Esteves SC1
  • Evans A1
  • Hamed MA1
  • Humaidan P1
Affiliations (unnormalised)6
  • Andrology and Human Reproduction Clinic1
  • Copenhagen University Hospital1
  • Department of Clinical Medicine1
  • Department of Medical Laboratory Science1
  • Desai Sethi Urology Institute1
  • Federal University of Health Sciences1

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

The inability of the male to effect FERTILIZATION of an OVUM after a specified period of unprotected intercourse. Male sterility is permanent infertility.

Identifiers
MeSHInfertility, Male
References & data sources
  • Disease identity & definition — NLM Medical Subject Headings (MeSH), public domain
  • Clinical trials — ClinicalTrials.gov (U.S. National Library of Medicine)
  • Research activity — Europe PMC (EMBL-EBI) + OpenAlex-derived paper links
  • Related entities are derived from literature co-mention (studied together) — associative, not causal.