Back to results

Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

Primary Purpose

Infertility

Status

Completed

Phase

Phase 4

Locations

Belgium

Study Type

Interventional

Intervention

Decapeptyl Daily

pregnyl

About this trial

This is an interventional treatment trial for Infertility focused on measuring ovarian hyper stimulation syndrome (OHSS), metaphase II oocytes (MII), good quality embryo's, implantation, pregnancy

Eligibility Criteria

undefined - 38 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

A Z Jan Palfijn

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

hCG

hCG and GnRH agonist

Arm Description

5000 IU Pregnyl SC

5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC

Outcomes

Primary Outcome Measures

MII Oocytes

the number of mature oocytes retrieved

Secondary Outcome Measures

Pregnancy Rate

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

Patients With Cryopreserved Embryos

Full Information

NCT ID

NCT01607203

First Posted

May 4, 2012

Last Updated

February 3, 2015

Sponsor

AZ Jan Palfijn Gent

Collaborators

Onze Lieve Vrouw Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01607203

Brief Title

Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

Official Title

Randomised Controlled Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (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

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.

6. Conditions and Keywords

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

Infertility

Keywords

ovarian hyper stimulation syndrome (OHSS), metaphase II oocytes (MII), good quality embryo's, implantation, 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

hCG

Arm Type

Active Comparator

Arm Description

5000 IU Pregnyl SC

Arm Title

hCG and GnRH agonist

Arm Type

Active Comparator

Arm Description

5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC

Intervention Type

Drug

Intervention Name(s)

Decapeptyl Daily

Other Intervention Name(s)

Gonapeptyl

Intervention Description

Decapeptyl 0.2 mg SC once 1day

Intervention Type

Drug

Intervention Name(s)

pregnyl

Intervention Description

5000 IU SC

Primary Outcome Measure Information:

Title

MII Oocytes

Description

the number of mature oocytes retrieved

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Pregnancy Rate

Description

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

Time Frame

12 weeks

Title

Patients With Cryopreserved Embryos

Time Frame

4 weeks

10. Eligibility

Sex

Female

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wim Decleer, gynacologist

Organizational Affiliation

IVF Centrum Jan Palfijn Gent

Official's Role

Principal Investigator

Facility Information:

Facility Name

A Z Jan Palfijn

City

Gent

State/Province

Oost-vlaanderen

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

We'll reach out to this number within 24 hrs