NCT01607203

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.

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
6 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 30, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 19, 2015

Completed
Last Updated

February 19, 2015

Status Verified

February 1, 2015

Enrollment Period

2.1 years

First QC Date

May 4, 2012

Results QC Date

December 30, 2013

Last Update Submit

February 3, 2015

Conditions

Keywords

ovarian hyper stimulation syndrome (OHSS)metaphase II oocytes (MII)good quality embryo'simplantationpregnancy

Outcome Measures

Primary Outcomes (1)

  • MII Oocytes

    the number of mature oocytes retrieved

    3 weeks

Secondary Outcomes (2)

  • Pregnancy Rate

    12 weeks

  • Patients With Cryopreserved Embryos

    4 weeks

Study Arms (2)

hCG

ACTIVE COMPARATOR

5000 IU Pregnyl SC

Drug: pregnyl

hCG and GnRH agonist

ACTIVE COMPARATOR

5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC

Drug: Decapeptyl DailyDrug: pregnyl

Interventions

Decapeptyl 0.2 mg SC once 1day

Also known as: Gonapeptyl
hCG and GnRH agonist

5000 IU SC

hCGhCG and GnRH agonist

Eligibility Criteria

AgeUp to 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • polycystic ovary syndrome (PCOS) patients
  • patients with endocrinological diseases or problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

A Z Jan Palfijn

Ghent, Oost-vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Infertility

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteins

Results Point of Contact

Title
dr.Decleer Wim
Organization
AZ JAN PALFIJN

Study Officials

  • Wim Decleer, gynacologist

    IVF Centrum Jan Palfijn Gent

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
gynaecologist

Study Record Dates

First Submitted

May 4, 2012

First Posted

May 30, 2012

Study Start

November 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 19, 2015

Results First Posted

February 19, 2015

Record last verified: 2015-02

Locations