Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation

STERILITY Clinical Trial

— DESCARTES  

Official title:

Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation Protocols Which Are the Most Common in Clinical Practice Using High Purified Gonadotrophins (u-FSH-HP y u-hMG-HP) in IVF/ICSI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331720
• Other study ID #: FER-MEN-2006-03
• Status: Completed
• Phase: N/A
• First received: April 6, 2011
• Last updated: April 7, 2011
• Start date: November 2007
• Est. completion date: July 2010

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

The aim of the study is to assess the effectiveness of 5 mixed protocols of ovarian hyperstimulation with urinary gonadotrophins to achieve clinical pregnancy in females undergoing assisted reproductive techniques (IVF/ICSI) (in-vitro fertilisation/intracytoplasmic sperm injection).

Study hypothesis: mixed protocols with urinary FSH (follicle-stimulating hormone) and urinary hMG (human menopausal gonadotropin)should be more effective than monotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: July 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Body mass index (BMI) between 18 and 30

• 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:

• Failure in 3 previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome
• STERILITY

Intervention

Drug:
• hMG-HP

Locations

Country	Name	City	State
Spain	Investigational site	Albacete
Spain	Investigational site	Alicante
Spain	Investigational site	Badajoz
Spain	Investigational site	Castellón
Spain	Investigational site	Elche	Alicante
Spain	Investigational site	Gijón	Asturias
Spain	Investigational site	Málaga
Spain	Investigational site	Mallorca
Spain	Investigational site	Murcia
Spain	Investigational site	Navarra	Pamplona
Spain	Investigational site	Santiago de Compostela	La Coruña
Spain	Investigational site Sta. Cruz	Tenerife
Spain	Investigational site	Valencia
Spain	Investigational site	Zaragoza

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		0-30 days	No
Secondary	Biochemical pregnancy rate		0-16 days	No