Assessment of the Therapeutic Utility of r-FSH in Association With hMG-HP

Ferring

Status: Completed

Conditions: Sterility

Treatments: Drug: hMG-HP/r-FSH

Study type: Observational

Funder types: Industry

Identifiers

NCT01330771

FER-GON-2004-01

Details and patient eligibility

About

To assess the effectiveness of a protocol of ovarian hyperstimulation combining urinary gonadotrophins + recombinant gonadotrophins, to achieve clinical pregnancy in females undergoing IVF.

Study hypothesis: to assess the effectiveness of protocols combining urinary gonadotrophins + recombinant gonadotrophins

Enrollment: 51 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 18-38 years
• Body mass index (BMI) between 18 and 30
• Women classified as normogonadotrophin patients. Not more than 3 previous cycles of ART (assisted reproductive technology)
• Testosterona, FSH (follicle-stimulating hormone), LH (luteinizing hormone) and Prolactin serum levels during the early folicular phase (days 2-4 of the cycle) within the laboratory normal range
• No administration of clomiphen citrate or gonadotropins during the month prior to the start of the study

Exclusion criteria

• Failure in previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
• Seminal samples not apt for IVF-ICSI (according to the criteria of each center). Evidence of significant bacterial infection in the seminogram of the couple in the preceding 6 months
• Data suggestive of possible ovarian failure
• Antecedents of severe ovarian hyperstimulation syndrome (OHSS)
• Important systemic disease
• Pregnancy or contraindication to pregnancy

Trial design

51 participants in 1 patient group

hMG-HP/r-FSH

Description:

Patients with a condition

Treatment:

Drug: hMG-HP/r-FSH