NCT01683513

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 2, 2021

Status Verified

February 1, 2021

Enrollment Period

3.3 years

First QC Date

August 23, 2012

Last Update Submit

February 1, 2021

Conditions

InfertilityPCOS

Keywords

OHSSmataphase II oocytes (MII)good quality embryo'spregnancy

Outcome Measures

Primary Outcomes (2)

  • MII oocytes

    The number of mature oocytes retrieved after stimulation without creating OHSS

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

  • 2 Pro Nuclei (2PN) fertilization

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

    24h after ICSI

Secondary Outcomes (2)

  • implantation rate

    12 weeks

  • OHSS

    one month with oocyte retrieval in the middle

Study Arms (2)

humaan chorion gonadotropine

NO INTERVENTION

ovulation induction with 5000E hCG

GnRH agonist + 1500E hCG

ACTIVE COMPARATOR

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

Drug: GnRh agonist +1500E hCG

Interventions

GnRh agonist +1500E hCGDRUG

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

GnRH agonist + 1500E hCG

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • endocrinal diseases or problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ Jan Palfijn

Ghent, Oost-vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Wim Decleer, gynecologist

    IVF Centrum Jan Palfijn Gent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
gynecologist

Study Record Dates

First Submitted

August 23, 2012

First Posted

September 12, 2012

Study Start

November 1, 2011

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 2, 2021

Record last verified: 2021-02

Locations

BE(1)