Corifollitropin Alfa Versus Daily rFSH in the Controlled Ovarian Stimulation of Poor Responders

NCT ID: NCT02254928

Last Updated: 2016-01-18

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

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-11-30

Brief Summary

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A randomised, crossover, multicentre, national, clinical trial comparing the efficacy of corifollitropin alfa versus daily recombinant FSH and HMG in the controlled ovarian stimulation of women with a poor ovarian response undergoing IVF treatments. The main objective of this study is comparing the number of oocytes obtained after the follicle puncture when using each of these two stimulation protocols. Only poor responders according to the Bologna criteria will be recruited for this trial. All participants will undergo two stimulation cycles to obtain and accumulate oocytes by vitrification. One of the cycles will be done with the corifollitropin alfa protocol and the other with daily rFSH and HMG, the order of application of these protocols will be randomised (crossover clinical trial) in each patient.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

First stimulation cycle with corifollitropin alfa (experimental) Second stimulation cycle with rFSH and HMG (active comparator)

Group Type OTHER

Corifollitropin alfa

Intervention Type DRUG

One dose of 150 μg of corifollitropin alfa will be administered at day 1 of stimulation. Stimulation will be continued with 250-300 IU/day of rFSH from day 8 forward.

Group 2

First stimulation cycle with rFSH and HMG (active comparator) Second stimulation cycle with corifollitropin alfa (experimental)

Group Type OTHER

Corifollitropin alfa

Intervention Type DRUG

One dose of 150 μg of corifollitropin alfa will be administered at day 1 of stimulation. Stimulation will be continued with 250-300 IU/day of rFSH from day 8 forward.

Interventions

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Corifollitropin alfa

One dose of 150 μg of corifollitropin alfa will be administered at day 1 of stimulation. Stimulation will be continued with 250-300 IU/day of rFSH from day 8 forward.

Intervention Type DRUG

Other Intervention Names

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Elonva

Eligibility Criteria

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Inclusion Criteria

* Advanced maternal age (≥40 years)
* A previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol)
* An abnormal ovarian reserve test (i.e. antral follicle count \<5-7 follicles or anti-mullerian hormone level \<0.5-1.1 ng/ml)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role collaborator

IVI Madrid

OTHER

Sponsor Role collaborator

IVI Barcelona

OTHER

Sponsor Role collaborator

Vida Recoletas Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IVI Barcelona

Barcelona, Barcelona, Spain

Site Status

IVI Madrid

Madrid, Madrid, Spain

Site Status

IVI Sevilla

Seville, Seville, Spain

Site Status

IVI Valencia

Valencia, Valencia, Spain

Site Status

Countries

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Spain

Other Identifiers

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MANCOR

Identifier Type: -

Identifier Source: org_study_id

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