Assessment of the Effectiveness and Tolerability of Ovarian Hyperstimulation

NCT ID: NCT01331720

Last Updated: 2011-04-08

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

279 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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STERILITY

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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FSH:LH 3:1 - Treatment Group C

Patients with a condition

hMG-HP

Intervention Type DRUG

FSH:LH 3:0 - Treatment Group D

Patients with a condition

hMG-HP

Intervention Type DRUG

Initially FSH:LH 3:0 and on S6 FSH:LH 1:1 - Treatment Group E

Patients with a condition

hMG-HP

Intervention Type DRUG

FSH:LH 1:1 - Treatment Group A

Patients with a condition

LH (luteinizing hormone)

hMG-HP

Intervention Type DRUG

FSH:LH 3:2 - Treatment Group B

Patients with a condition

hMG-HP

Intervention Type DRUG

Interventions

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hMG-HP

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring SAU

INDUSTRY

Sponsor Role collaborator

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

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

Site Status

Investigational site

Alicante, Alicante, Spain

Site Status

Investigational site

Elche, Alicante, Spain

Site Status

Investigational site

Badajoz, Badajoz, Spain

Site Status

Investigational site

Castellon, Castellón, Spain

Site Status

Investigational site

Santiago de Compostela, La Coruña, Spain

Site Status

Investigational site

Mallorca, Mallorca, Spain

Site Status

Investigational site

Murcia, Murcia, Spain

Site Status

Investigational site

Málaga, Málaga, Spain

Site Status

Investigational site

Navarra, Pamplona, Spain

Site Status

Investigational site

Gijón, Principality of Asturias, Spain

Site Status

Investigational site Sta. Cruz

Santa Cruz de Tenerife, Tenerife, Spain

Site Status

Investigational site

Valencia, Valencia, Spain

Site Status

Investigational site

Zaragoza, Zaragoza, Spain

Site Status

Countries

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Spain

Other Identifiers

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FER-MEN-2006-03

Identifier Type: -

Identifier Source: org_study_id

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