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NCT01330771 Clinical Trial

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

Sterility Clinical Trial

Official title:
Assessment of the Therapeutic Utility of r-FSH in Association With hMG-HP Within a Protocol of Controlled Ovarian Hyperstimulation in IVF in Normoresponders Women Undergoing Downregulation With GnRH Antagonist

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01330771
Other study ID # FER-GON-2004-01
Secondary ID
Status Completed
Phase N/A
First received April 6, 2011
Last updated April 6, 2011
Start date October 2006
Est. completion date September 2008

Study information
Verified date April 2011
Source Ferring Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 51
Est. completion date September 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 38 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• hMG-HP/r-FSH

Locations
Country Name City State
Spain Investigational site Valencia

Sponsors (2)
Lead Sponsor Collaborator
Ferring Pharmaceuticals Ferring SAU

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical pregnancy rate 30 days No
Secondary Biochemical pregnancy rate 16 days No
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