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Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients

Primary Purpose

Infertility, PCOS

Status

Completed

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

GnRh agonist +1500E hCG

About this trial

This is an interventional treatment trial for Infertility focused on measuring OHSS, mataphase II oocytes (MII), good quality embryo's, pregnancy

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

AZ Jan Palfijn

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

humaan chorion gonadotropine

GnRH agonist + 1500E hCG

Arm Description

ovulation induction with 5000E hCG

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

Outcomes

Primary Outcome Measures

MII oocytes

The number of mature oocytes retrieved after stimulation without creating OHSS

2 Pro Nuclei (2PN) fertilization

laboratory follow up of the fertilized egg during the first 24h

Secondary Outcome Measures

implantation rate

The number of pregnancies obtained wich still is the most important issue for the patients

OHSS

patient follow up according to subjective complaints and objective measures

Full Information

NCT ID

NCT01683513

First Posted

August 23, 2012

Last Updated

February 1, 2021

Sponsor

AZ Jan Palfijn Gent

Collaborators

Onze Lieve Vrouw Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01683513

Brief Title

Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients

Official Title

Prospective Randomized Trial on GnRH Agonist Triggering Versus hCG Triggering in IVF Stimulation in PCOS Patients

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

AZ Jan Palfijn Gent

Collaborators

Onze Lieve Vrouw Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, PCOS

Keywords

OHSS, mataphase II oocytes (MII), good quality embryo's, pregnancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

humaan chorion gonadotropine

Arm Type

No Intervention

Arm Description

ovulation induction with 5000E hCG

Arm Title

GnRH agonist + 1500E hCG

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

GnRh agonist +1500E hCG

Intervention Description

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

Primary Outcome Measure Information:

Title

MII oocytes

Description

The number of mature oocytes retrieved after stimulation without creating OHSS

Time Frame

patients will be followed during the stimulation with an average of 10 days

Title

2 Pro Nuclei (2PN) fertilization

Description

laboratory follow up of the fertilized egg during the first 24h

Time Frame

24h after ICSI

Secondary Outcome Measure Information:

Title

implantation rate

Description

The number of pregnancies obtained wich still is the most important issue for the patients

Time Frame

12 weeks

Title

OHSS

Description

patient follow up according to subjective complaints and objective measures

Time Frame

one month with oocyte retrieval in the middle

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wim Decleer, gynecologist

Organizational Affiliation

IVF Centrum Jan Palfijn Gent

Official's Role

Principal Investigator

Facility Information:

Facility Name

AZ Jan Palfijn

City

Gent

State/Province

Oost-vlaanderen

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

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Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients

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