Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation (DESCARTES)
This study has been completed.
Sponsor:
Ferring Pharmaceuticals
Collaborator:
Ferring SAU
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01331720
First received: April 6, 2011
Last updated: April 7, 2011
Last verified: April 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
STERILITY |
Drug: hMG-HP |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Further study details as provided by Ferring Pharmaceuticals:
Primary Outcome Measures:
- Clinical pregnancy rate [ Time Frame: 0-30 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Biochemical pregnancy rate [ Time Frame: 0-16 days ] [ Designated as safety issue: No ]
| Enrollment: | 279 |
| Study Start Date: | November 2007 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
FSH:LH 1:1 - Treatment Group A
Patients with a condition LH (luteinizing hormone) |
Drug: hMG-HP |
|
FSH:LH 3:2 - Treatment Group B
Patients with a condition
|
Drug: hMG-HP |
|
FSH:LH 3:1 - Treatment Group C
Patients with a condition
|
Drug: hMG-HP |
|
FSH:LH 3:0 - Treatment Group D
Patients with a condition
|
Drug: hMG-HP |
|
Initially FSH:LH 3:0 and on S6 FSH:LH 1:1 - Treatment Group E
Patients with a condition
|
Drug: hMG-HP |
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Females affected by sterility able to undergo IVF/ICSI
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01331720
Locations
| Spain | |
| Investigational site | |
| Elche, Alicante, Spain | |
| Investigational site | |
| Gijón, Asturias, Spain | |
| Investigational site | |
| Santiago de Compostela, La Coruña, Spain | |
| Investigational site | |
| Navarra, Pamplona, Spain | |
| Investigational site | |
| Albacete, Spain | |
| Investigational site | |
| Alicante, Spain | |
| Investigational site | |
| Badajoz, Spain | |
| Investigational site | |
| Castellón, Spain | |
| Investigational site | |
| Mallorca, Spain | |
| Investigational site | |
| Murcia, Spain | |
| Investigational site | |
| Málaga, Spain | |
| Investigational site Sta. Cruz | |
| Tenerife, Spain | |
| Investigational site | |
| Valencia, Spain | |
| Investigational site | |
| Zaragoza, 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: | NCT01331720 History of Changes |
| Other Study ID Numbers: | FER-MEN-2006-03 |
| Study First Received: | April 6, 2011 |
| Last Updated: | April 7, 2011 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Additional relevant MeSH terms:
|
Ovarian Hyperstimulation Syndrome Infertility Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Genital Diseases, Male |
ClinicalTrials.gov processed this record on May 16, 2013