Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation
NCT ID: NCT01331720
Last Updated: 2011-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
279 participants
OBSERVATIONAL
2007-11-30
2010-07-31
Brief Summary
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Study hypothesis: mixed protocols with urinary FSH (follicle-stimulating hormone) and urinary hMG (human menopausal gonadotropin)should be more effective than monotherapy.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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FSH:LH 3:1 - Treatment Group C
Patients with a condition
hMG-HP
FSH:LH 3:0 - Treatment Group D
Patients with a condition
hMG-HP
Initially FSH:LH 3:0 and on S6 FSH:LH 1:1 - Treatment Group E
Patients with a condition
hMG-HP
FSH:LH 1:1 - Treatment Group A
Patients with a condition
LH (luteinizing hormone)
hMG-HP
FSH:LH 3:2 - Treatment Group B
Patients with a condition
hMG-HP
Interventions
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hMG-HP
Eligibility Criteria
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Inclusion Criteria
* Prolactin within the laboratory normal range
* Couples affected by sterility able to treat by IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
* Patients undergoing Menopur® and/or Bravelle® treatment
* Normal thyroid function
* Women not receiving clomifen citrate or gonadotrophins within one month prior study start
* Couples willing to participate in the study that have signed the informed consent form
Exclusion Criteria
* Policystic ovarian syndrome
* 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
* Antecedents of severe ovarian hyperstimulation syndrome (OHSS)
* Important systemic disease
* Pregnancy or contraindication to pregnancy
FEMALE
No
Sponsors
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Ferring SAU
INDUSTRY
Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Ferring Pharmaceuticals
Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Investigational site
Albacete, Albacete, Spain
Investigational site
Alicante, Alicante, Spain
Investigational site
Elche, Alicante, Spain
Investigational site
Badajoz, Badajoz, Spain
Investigational site
Castellon, Castellón, Spain
Investigational site
Santiago de Compostela, La Coruña, Spain
Investigational site
Mallorca, Mallorca, Spain
Investigational site
Murcia, Murcia, Spain
Investigational site
Málaga, Málaga, Spain
Investigational site
Navarra, Pamplona, Spain
Investigational site
Gijón, Principality of Asturias, Spain
Investigational site Sta. Cruz
Santa Cruz de Tenerife, Tenerife, Spain
Investigational site
Valencia, Valencia, Spain
Investigational site
Zaragoza, Zaragoza, Spain
Countries
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Other Identifiers
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FER-MEN-2006-03
Identifier Type: -
Identifier Source: org_study_id
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