Assessment of the Therapeutic Utility of hMG-HP

NCT ID: NCT01330784

Last Updated: 2011-04-07

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

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-09-30

Brief Summary

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To assess the effectiveness of a protocol of ovarian hyperstimulation with urinary gonadotrophins, to achieve clinical pregnancy in females undergoing IVF.

Study hypothesis: to assess the effectiveness of a protocol of urinary gonadotrophins

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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hMG-HP

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

* Women aged 18-38 years
* Body mass index (BMI) between 18 and 30
* Women classified as normogonadotrophin patients. Not more than 3 previous cycles of ART (assisted reproductive technology)
* Testosterona, FSH (follicle-stimulating hormone) LH (luteinizing hormone) and Prolactin serum levels during the early folicular phase (days 2-4 of the cycle) within the laboratory normal range
* No administration of clomiphen citrate or gonadotropins during the month prior to the start of the study

Exclusion Criteria

* Failure in previous cycles of assisted reproduction IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection)
* 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
* Data suggestive of possible ovarian failure
* Antecedents of severe ovarian hyperstimulation syndrome (OHSS)
* Important systemic disease
* Pregnancy or contraindication to pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

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

Valencia, Valencia, Spain

Site Status

Countries

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Spain

Other Identifiers

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FER-GON-2004-02

Identifier Type: -

Identifier Source: org_study_id

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