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Treatment patterns and clinical outcomes of Recombinant Follicle Stimulating Hormone in South Korean patients who received Controlled Ovarian Hyper-stimulation: Results from a retrospective observational chart review study

Treatment patterns and clinical outcomes of Recombinant Follicle Stimulating Hormone in South Korean patients who received Controlled Ovarian Hyper-stimulation: Results from a retrospective observational chart review study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0004067
Enrollment
700
Registered
2019-06-17
Start date
2019-08-20
Completion date
Unknown
Last updated
2020-01-14

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

Conditions

None listed

Interventions

None listed

Sponsors

Ferring pharmaceuticals Korea
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. South Korean female patients who received controlled ovarian hyperstimulation for assisted reproductive technology procedures such as IVF or ICSI from January 2013 to December 2017. 2. Women between the ages of 18 and 40 years at the time of controlled ovarian hyperstimulation. 3. The first controlled ovarian hyperstimulation cycle. 4. Body mass index between 17.5 and 32.0 kg/m2 (both inclusive). 5. Subjects who received the procedure using a GnRH antagonist cycle. 6. Subjects who received rFSH only. 7. Controlled ovarian hyperstimulation cycle = 20 days. 8. Regular menstrual cycles of 24–35 days (both inclusive), presumed to be ovulatory. 9. AMH levels available within 1 year prior to controlled ovarian hyperstimulation.

Exclusion criteria

Exclusion criteria: 1. Known endometriosis stage III–IV. 2. Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy and before week 24 of pregnancy). 3. Any known clinically significant systemic disease (e.g., insulin-dependent diabetes). 4. Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events. 5. Any known endocrine or metabolic abnormalities. 6. Known moderate or severe impairment of renal or hepatic function. 7. Use of any rFSH preparations during the last 3 months before controlled ovarian hyperstimulation.

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rate at 10~11 weeks, %

Secondary

MeasureTime frame
Live birth rates, The number of retrieved oocytes, The number of mature oocytes;Incidence rate of Ovarian Hyperstimulation Syndrome %, Hospitalization due to Ovarian Hyperstimulation Syndrome)

Countries

Korea, Republic of

Contacts

Public ContactYoung-Mi Jeon

Chung-Ang Univerisity Hospital

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026