Assessment of the Therapeutic Utility of hMG-HP

Ferring

Status: Completed

Conditions: Sterility

Treatments: Drug: hMG-HP

Study type: Observational

Funder types: Industry

Identifiers

NCT01330784

FER-GON-2004-02

Details and patient eligibility

About

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

Study hypothesis: to assess the effectiveness of a protocol of urinary gonadotrophins

Enrollment: 61 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

61 participants in 1 patient group

hMG-HP

Description:

Patients with a condition

Treatment:

Drug: hMG-HP