Cost-effectiveness study of controlled ovarian stimulation with recombinant FSH.

JRCT ID: jRCT1031230698

Registered date:13/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Infertility
• Date of first enrollment: 13/03/2024
• Target sample size: 400
• Study type: Observational

Outcome(s)

• Primary Outcome: Calculation of ICER for follitropin delta and follitropin alpha using cumulative pregnancy rate as an efficacy index.
• Secondary Outcome: ICER calculation of follitropin delta and follitropin alpha using the number of oocytes retrieved, number of fertilizations zygotes (2PN), and number of blastocysts as efficacy indicators.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: < 43age old
• Gender: Female

Include criteria

Patients receiving assisted reproductive technology (IVF/ICSI) using follitropin delta or follitropin alpha as FSH mono protocol COS for the first time and who have never received assisted reproductive technology before. (First ART patients)
Patients covered by insurance up to age 42.

Exclude criteria

Patients who deviate from the package insert for follitropin delta and follitropin alpha (contraindications).
Patients who received concomitant administration of hMG preparations, urine-derived FSH preparations, clomiphene, or letrozole in addition to follitropin delta or alpha.

Related Information

• Primary Sponsor: Kobanawa Masato
• Source(s) of Monetary Support: Ferring Pharmaceuticals