NCT00750100

Brief Summary

In this study,the investigators compared two protocols for controlled ovarian hyperstimulation in infertility patients requiring IVF. In the control group, the patient undergoes a standard antagonist protocol. In the study group, the administration of gonadotropins is stopped in the late follicular phase and replaced by low dose human chorionic gonadotropins. The primary endpoint of the study is the number of oocytes retrieved in both groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2007

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

September 1, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

October 11, 2010

Status Verified

September 1, 2008

Enrollment Period

4 months

First QC Date

September 9, 2008

Last Update Submit

October 8, 2010

Conditions

Infertility

Keywords

infertilityIVFhCGprimary infertilitysecondary infertilitypatients requiring in-vitro fertilisation

Outcome Measures

Primary Outcomes (1)

  • Number of oocytes in both treatment groups

    up to 9 months

Secondary Outcomes (1)

  • Duration of stimulation in both treatment groups, amount of gonadotropins consumed in each treatment group

    up to 9 months

Study Arms (2)

A

ACTIVE COMPARATOR

Patients undergo a standard antagonist protocol for in-vitro fertilisation, and are stimulated with recombinant gonadotropins.

Drug: recombinant gonadotropins

B

EXPERIMENTAL

Patients are undergo an antagonist protocol for in-vitro fertilisation and are stimulated with recombinant gonadotropins. When the patient has an estradiol value of 600 ng/L or more and when the patient has at least 6 follicles of 12 mm, the administration of gonadotropins is stopped and replaced by low dose human chorionic gonadotropins.

Drug: human chorionic gonadotropin

Interventions

human chorionic gonadotropinDRUG

hCG 200IU in the late follicular phase

Also known as: Pregnyl, NV Organon, Oss, The Netherlands
B
recombinant gonadotropinsDRUG

200 IU per day during controlled ovarian stimulation

Also known as: Puregon, NV Organon, Oss, The Netherlands
A

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \< 36 years on day of randomisation
  • FSH \< 12 in the early follicular phase
  • Normal ultrasound scan
  • BMI between 18 and 29 (both inclusive)
  • Randomisation at outpatient clinic

You may not qualify if:

  • Endometriosis ≥ grade 3
  • PCO syndrome
  • Poor responder
  • Endocrine or metabolic abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Laarbeeklaan 101, Brussels Capital, 1090, Belgium

Location

Related Publications (2)

  • Filicori M, Cognigni GE, Gamberini E, Parmegiani L, Troilo E, Roset B. Efficacy of low-dose human chorionic gonadotropin alone to complete controlled ovarian stimulation. Fertil Steril. 2005 Aug;84(2):394-401. doi: 10.1016/j.fertnstert.2005.02.036.

    PMID: 16084880BACKGROUND

  • Blockeel C, De Vos M, Verpoest W, Stoop D, Haentjens P, Devroey P. Can 200 IU of hCG replace recombinant FSH in the late follicular phase in a GnRH-antagonist cycle? A pilot study. Hum Reprod. 2009 Nov;24(11):2910-6. doi: 10.1093/humrep/dep253. Epub 2009 Jul 17.

    PMID: 19617207DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Chorionic Gonadotropinfollitropin beta

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Christophe Blockeel, MD

    UZ Brussel, Centre for Reproductive Medicine, Brussels

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2008

First Posted

September 10, 2008

Study Start

September 1, 2007

Primary Completion

January 1, 2008

Study Completion

November 1, 2008

Last Updated

October 11, 2010

Record last verified: 2008-09

Locations

BE(1)