Special Drug Use-Results Survey of Gonalef (Subcutaneous injection 75/150, Subcutaneous injection pen 300/450/900) for Ovulation Induction in Patients with Anovulation or Oligo-Ovulation Accompanying Hypothalamic-Pituitary Dysfunction or Polycystic Ovary Syndrome Patients

Special Drug Use-Results Survey of Gonalef (Subcutaneous injection 75/150, Subcutaneous injection pen 300/450/900) for Ovulation Induction in Patients with Anovulation or Oligo-Ovulation Accompanying Hypothalamic-Pituitary Dysfunction or Polycystic Ovary Syndrome Patients - Special Drug Use-Results Survey of Gonalef (OI)

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033665

Enrollment

Registered

2018-08-08

Start date

2009-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovulation Induction in Patients with Anovulation or Oligo-Ovulation Accompanying Hypothalamic-Pituitary Dysfunction or Polycystic Ovary Syndrome (OI)

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Among patients who were administrated Gonalef for patient with ovulation induction in patients with anovulation or oligo-ovulation accompanying hypothalamic-pituitary dysfunction or polycystic ovary syndrome (OI), mothers whose pregnancy was confirmed and their babies in the Drug Use-Results Survey of Gonalef (Subcutaneous injection 75/150, Subcutaneous injection pen 300/450/900) for patient with OI.

Exclusion criteria

Exclusion criteria: Patients who do not give a full consent to this survey.

Design outcomes

Primary

Measure	Time frame
(Safety) 1-1. Adverse drug reactions and infections (term, severity, incidence, etc.) 1-2. Factors related to safety (term and incidence of adverse drug reactions, etc. by patient background)	—

Secondary

Measure	Time frame
(Effectiveness) 1-1. Factors related to effectiveness (ovulation rate by patient background) 1-2. Pregnancy Rate 1-3. Course of Pregnant/Postpartum Women and Delivered Children	—

Countries

Japan

Contacts

Public ContactHiroshi Suzuka

Merck Serono Co., Ltd. PMS Planning & Strategy, Medical Department

hiroshi.suzuka@merckgroup.com03-6756-0837

Outcome results