Assessment of the Therapeutic Utility of hMG-HP

This study has been completed.
Sponsor:
Collaborator:
Ferring SAU
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01330784
First received: April 6, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

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


Condition Intervention
Sterility
Drug: hMG-HP

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Therapeutic Utility of hMG-HP Within a Protocol of Controlled Ovarian Hyperstimulation in IVF in Normoresponders Women Undergoing Downregulation With GnRH Antagonist

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical pregnancy rate [ Time Frame: 16 days ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: October 2006
Study Completion Date: September 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
hMG-HP
Patients with a condition
Drug: hMG-HP

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Females affected by sterility able to undergo IVF

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01330784

Locations
Spain
Investigational site
Valencia, Spain
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring SAU
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01330784     History of Changes
Other Study ID Numbers: FER-GON-2004-02
Study First Received: April 6, 2011
Last Updated: April 6, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 26, 2014