Aneuploidy Rate and Stimulation Protocol: Recombinant Follicle Stimulating Hormone (FSH) Versus Human FSH

NCT ID: NCT01164943

Last Updated: 2016-02-25

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

TERMINATED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-12-31

Brief Summary

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Several stimulation protocols have been used in in vitro fertilization (IVF) in a cycle of egg donation; recombinant FSH and human FSH are included. The effect of each kind of hormone on aneuploidy rate it is unknown. If there was an increase on aneuploidy rate of one of these stimulation protocols, there will be a negative effect on the successful rates in the egg donation cycles. The aim of this study is to observe if there is a different in aneuploidy rate and morphological oocyte parameters between different stimulation protocols.

Detailed Description

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Conditions

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Aneuploidy Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Human FSH

Group Type ACTIVE_COMPARATOR

Stimulation with human FSH

Intervention Type PROCEDURE

Human FSH

Recombinant FSH

Group Type ACTIVE_COMPARATOR

Stimulation with recombinant FSH

Intervention Type PROCEDURE

Recombinant FSH

Interventions

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Stimulation with human FSH

Human FSH

Intervention Type PROCEDURE

Stimulation with recombinant FSH

Recombinant FSH

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Egg donation cycles with more than 8MII in oocyte retrieval day

Exclusion Criteria

* Male factor
* Uterine malformations
* genetic alterations
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IVI Madrid

OTHER

Sponsor Role lead

Responsible Party

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Juan A Garcia-Velasco

PhD, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Insituto Valenciano de Infertilida, Spain, Madrid

Madrid, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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MAD-FB-04-2010-01

Identifier Type: -

Identifier Source: org_study_id

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