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Step Up Versus Step Down in Controlled Ovarian Stimulation

NCT ID: NCT01376999

Last Updated: 2017-09-20

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

Clinical Phase

PHASE4

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2014-02-28

Brief Summary

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The aim of the study is to evaluate if the Step up protocol is equal or superior regarding efficacy and security than the step down protocol. In couple submitted two intrauterine insemination.

Detailed Description

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Conditions

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No Explained Sterility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Step Down

Step Down: We begin the COS (controlled ovarian stimulation) with 150 IU of FSH-r until 7th day of stimulation. This day we make an adjustment reducing the dose if necessary.

Group Type EXPERIMENTAL

FSH-r (Follicule stimulate hormone)

Intervention Type DRUG

Step-Up: 75 IU FSH-r Step-Down: 150 FSH-r

Step Up

Step up: We begin the COS (controlled ovarian stimulation) with 75 IU of FSH-r until 7th day of stimulation.This day we make an adjustment increasing the dose if necessary.

Group Type ACTIVE_COMPARATOR

FSH-r (Follicule stimulate hormone)

Intervention Type DRUG

Step-Up: 75 IU FSH-r Step-Down: 150 FSH-r

Interventions

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FSH-r (Follicule stimulate hormone)

Step-Up: 75 IU FSH-r Step-Down: 150 FSH-r

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women with unexplained sterility with needs of intrauterine insemination.

Exclusion Criteria

* Contraindications to intrauterine insemination.
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Parc de Salut Mar

OTHER

Sponsor Role lead

Responsible Party

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Miguel Angel Checa

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital del Mar

Barcelona, , Spain

Site Status

Countries

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Spain

References

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Robles A, Gayete-Lafuente S, Prat M, Gonzalez-Comadran M, Checa MA. The step-up protocol increases clinical pregnancy rates compared with the step-down in patients with unexplained infertility. A randomized controlled trial. JBRA Assist Reprod. 2022 Nov 9;26(4):599-605. doi: 10.5935/1518-0557.20210112.

Reference Type DERIVED
PMID: 35243855 (View on PubMed)

Other Identifiers

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UREP-01-2009

Identifier Type: -

Identifier Source: org_study_id