Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

NCT ID: NCT01607203

Last Updated: 2015-02-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.

Detailed Description

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Conditions

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Infertility

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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hCG

5000 IU Pregnyl SC

Group Type ACTIVE_COMPARATOR

pregnyl

Intervention Type DRUG

5000 IU SC

hCG and GnRH agonist

5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC

Group Type ACTIVE_COMPARATOR

Decapeptyl Daily

Intervention Type DRUG

Decapeptyl 0.2 mg SC once 1day

pregnyl

Intervention Type DRUG

5000 IU SC

Interventions

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Decapeptyl Daily

Decapeptyl 0.2 mg SC once 1day

Intervention Type DRUG

pregnyl

5000 IU SC

Intervention Type DRUG

Other Intervention Names

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Gonapeptyl

Eligibility Criteria

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Inclusion Criteria

* Intra-cytoplasmic sperm injection (ICSI) patients below 38 years
* 1,2 or 3 rd IVF-cycle

Exclusion Criteria

* polycystic ovary syndrome (PCOS) patients
* patients with endocrinological diseases or problems
Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Onze Lieve Vrouw Hospital

OTHER

Sponsor Role collaborator

AZ Jan Palfijn Gent

OTHER

Sponsor Role lead

Responsible Party

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Dr. Decleer Wim

gynaecologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wim Decleer, gynacologist

Role: PRINCIPAL_INVESTIGATOR

IVF Centrum Jan Palfijn Gent

Locations

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A Z Jan Palfijn

Ghent, Oost-vlaanderen, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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Dr. Decleer Wim

Identifier Type: -

Identifier Source: org_study_id

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