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

Not Applicable

Active, not recruiting

Conditions: Diseases of The genitoruinary system

Registration Number: KCT0004067

Lead Sponsor: Ferring pharmaceuticals Korea

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Active, not recruiting

Sex: Female

Target Recruitment: 700

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

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.

Study & Design

Study Type: Observational Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate at 10~11 weeks, %

Secondary Outcome Measures

Name	Time	Method
ive birth rates, The number of retrieved oocytes, The number of mature oocytes;Incidence rate of Ovarian Hyperstimulation Syndrome %, Hospitalization due to Ovarian Hyperstimulation Syndrome)