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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01331720
Other study ID # FER-MEN-2006-03
Secondary ID
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
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