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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01330771
Enrollment
51
Registered
2011-04-07
Start date
2006-10-31
Completion date
2008-09-30
Last updated
2011-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sterility

Brief 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

Interventions

DRUGhMG-HP/r-FSH

Sponsors

Ferring SAU
CollaboratorINDUSTRY
Ferring Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Clinical pregnancy rate30 days

Secondary

MeasureTime frame
Biochemical pregnancy rate16 days

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026