Back to discover
Disease

Anovulation

Late-stage therapeutic developmentEmerging research
MeSHAnovulation
1
Publications
8
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 with recent milestones.
Clinical Milestones1View
Recently completed 1
Activity timeline1

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 alfaapproved

Approval — In adult women: anovulation (including polycystic ovarian disease, PCOD) in women who ha… (2014)

Follitropin betaapproved

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

Clinical trials

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

The current development programme across all trial phases.

Clinical programme
8
All trials
1
Active
5
Late-stage
6
Completed
Late-stage studies

Administration of Single High Dose Letrozole for Ovulation Induction - A Randomized Controlled Trial

Phase 4 · Completed · Mount Sinai Hospital, Canada

Intrauterine Infusion of Autologous Platelet-rich Plasma to Prevent a Thin Endometrium in Infertile Women Undergoing Clomiphene Citrate Therapy: a Pilot Prospective Self-controlled Trial

Phase 2/3 · Completed · Benha University

A Randomized, Assessor-blinded, Parallel Group, Multi-center, Non-inferiority Study Investigating the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection for Ovulation Induction Using a Low-dose, Step-up Protocol in Chinese Females With WHO Group II Anovulatory Infertility Failing to Conceive on Clomiphene Citrate

Phase 3 · Completed · Ferring Pharmaceuticals

A Phase III Clinical Study for the Comparison Evaluation of DA-3801 and Gonal-F® in Infertile Female Patients With Chronic Anovulation Syndrome

Phase 3 · Completed · Dong-A ST Co., Ltd.

Open-Label, Parallel-Group, Randomized, Multicenter Phase III Trial to Compare the Efficacy and Safety of a 250 mcg SC Dose of MSJ-0011 to a 5,000 IU IM Dose of Urinary Human Chorionic Gonadotropin in Inducing Ovulation in Japanese Women Diagnosed With Anovulation or Oligo-Ovulation Secondary to Hypothalamic-Pituitary Dysfunction or Polycystic Ovarian Syndrome, and Who Are Undergoing Ovulation Induction With Follitropin Alfa

Phase 3 · Completed · Merck KGaA, Darmstadt, Germany
Recently completed

Administration of Single High Dose Letrozole for Ovulation Induction - A Randomized Controlled Trial

Phase 4 · Completed · Mount Sinai Hospital, Canada

Intrauterine Infusion of Autologous Platelet-rich Plasma to Prevent a Thin Endometrium in Infertile Women Undergoing Clomiphene Citrate Therapy: a Pilot Prospective Self-controlled Trial

Phase 2/3 · Completed · Benha University

Effect of Amlodipine and Clomid on Blood Flow of Preovulatory Follicle in Polycystic Ovarian Patients

N/A · Completed · Ahmed Fathy Ali Mohamed Ghanem

A Randomized, Assessor-blinded, Parallel Group, Multi-center, Non-inferiority Study Investigating the Efficacy and Safety of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection for Ovulation Induction Using a Low-dose, Step-up Protocol in Chinese Females With WHO Group II Anovulatory Infertility Failing to Conceive on Clomiphene Citrate

Phase 3 · Completed · Ferring Pharmaceuticals

Open-Label, Parallel-Group, Randomized, Multicenter Phase III Trial to Compare the Efficacy and Safety of a 250 mcg SC Dose of MSJ-0011 to a 5,000 IU IM Dose of Urinary Human Chorionic Gonadotropin in Inducing Ovulation in Japanese Women Diagnosed With Anovulation or Oligo-Ovulation Secondary to Hypothalamic-Pituitary Dysfunction or Polycystic Ovarian Syndrome, and Who Are Undergoing Ovulation Induction With Follitropin Alfa

Phase 3 · Completed · Merck KGaA, Darmstadt, Germany

A Phase III Clinical Study for the Comparison Evaluation of DA-3801 and Gonal-F® in Infertile Female Patients With Chronic Anovulation Syndrome

Phase 3 · Completed · Dong-A ST Co., Ltd.

Regulatory timeline

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

First approvals
2014emaApproval — Follitropin alfa· In adult women: anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate; stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT); follitropin alfa in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/l. In adult men: follitropin alfa is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human Chorionic Gonadotrophin (hCG) therapy. source ↗
2013emaApproval — Follitropin alfa· In adult women Anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomifene citrate; Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer; Ovaleap in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/L. In adult men Ovaleap is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotropic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy. source ↗
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 ↗
1995emaApproval — Follitropin alfa· Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate. Stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in-vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT). GONAL-f in association with a luteinising hormone (LH) preparation is recommended for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2 IU/l. GONAL-f is indicated for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hCG) therapy. 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

1 papers

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

Major themes2
  • Anti-Mullerian Hormone1
  • Polycystic Ovary Syndrome1
Leading journals1
  • European journal of endocrinology1
Leading researchers3
  • Monteiro MP1
  • Pignatelli D1
  • Vale-Fernandes E1
Affiliations (unnormalised)6
  • Centre for Medically Assisted Procreation/Public Gamete Bank1
  • Clinical and Experimental Endocrinology1
  • I3S Institute for Innovation in Health1
  • ITR-Laboratory for Integrative and Translational Research in Population Health1
  • University Hospital S João and Faculty of Medicine of the University of Porto1
  • University of Porto1

Reference

Authoritative identity, definition & identifiers.

Defined in MeSH

Suspension or cessation of OVULATION in animals or humans with follicle-containing ovaries (OVARIAN FOLLICLE). Depending on the etiology, OVULATION may be induced with appropriate therapy.

Identifiers
MeSHAnovulation
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.