Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients

NCT ID: NCT01683513

Last Updated: 2021-02-02

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-02-28

Brief Summary

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In this study the investigators compare the traditional way of triggering with a new way in patients with Poly Cystic Ovary Syndrome (PCOS). This to reduce the risque of Ovary Hyper Stimulation Syndrome (OHSS) in In Vitro Fertilization/ IntraCytoplastic Sperm Injection (IVF/ ICSI) treatment. The investigators also compare the number of mature oocytes, embryo's and pregnancy rate.

Detailed Description

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Conditions

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Infertility PCOS

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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humaan chorion gonadotropine

ovulation induction with 5000E hCG

Group Type NO_INTERVENTION

No interventions assigned to this group

GnRH agonist + 1500E hCG

ovulation induction with GnRH agonist and 1500E hCG one hour after egg retrieval

Group Type ACTIVE_COMPARATOR

GnRh agonist +1500E hCG

Intervention Type DRUG

ovulation induction with GnRh agonist and 1500E hCG one hour after egg retrieval

Interventions

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GnRh agonist +1500E hCG

ovulation induction with GnRh agonist and 1500E hCG one hour after egg retrieval

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ICSI patients below 38 years
* 1, 2 and 3e IVF cycle
* Body Mass Index (BMI) less than 32
* PCOS patients

Exclusion Criteria

* endocrinal diseases or problems
Minimum Eligible Age

18 Years

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

gynecologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wim Decleer, gynecologist

Role: PRINCIPAL_INVESTIGATOR

IVF Centrum Jan Palfijn Gent

Locations

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AZ Jan Palfijn

Ghent, Oost-vlaanderen, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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Dr. Decleer W

Identifier Type: -

Identifier Source: org_study_id

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