NCT00415766

Brief Summary

The purpose of this study is to compare the clinical outcomes of recombinant human chorionic gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 22, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 25, 2006

Completed
6.4 years until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

2.5 years

First QC Date

December 22, 2006

Last Update Submit

January 18, 2016

Conditions

Infertility

Keywords

recombinant hCGurinary hCG

Outcome Measures

Primary Outcomes (1)

  • Percentage of mature oocytes

    Percentage MII/COCs

    Day of oocyte retrieval (Day 0)

Secondary Outcomes (8)

  • Positive test per embryo transfer

    15 days post oocyte retrieval

  • Clinical pregnancy per embryo transfer

    7 weeks of gestation

  • Ongoing pregnancy per embryo transfer

    12 weeks of gestation

  • Level of serum hCG on day of oocyte retrieval

    Day of oocyte retrieval

  • Number of oocytes (COC) retrieved

    Day of oocyte retrieval

  • +3 more secondary outcomes

Study Arms (3)

rHCG 250 ug

ACTIVE COMPARATOR

Injection of 250 ug Ovitrelle to trigger final oocyte maturation

Drug: rHCG 250ug

uHCG 5000 IU

ACTIVE COMPARATOR

Injection of 5000 IU Pregnyl to trigger final oocyte maturation

Drug: uHCG 5000 IU

uHCG 7500 IU

ACTIVE COMPARATOR

Injection of 7500 IU Pregnyl to trigger final oocyte maturation

Drug: uHCG 7500 IU

Interventions

rHCG 250ugDRUG

Injection of 250 ug Ovitrelle to trigger final oocyte maturation

Also known as: Ovitrelle
rHCG 250 ug
uHCG 5000 IUDRUG

Injection of 5000 IU Pregnyl to trigger final oocyte maturation

Also known as: Pregnyl 5000 IU
uHCG 5000 IU
uHCG 7500 IUDRUG

Injection of 7500 IU Pregnyl to trigger final oocyte maturation

Also known as: Pregnyl 7500 IU
uHCG 7500 IU

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • At least 14 follicles \>11mm on the day of triggering final oocyte maturation
  • Pretreated with GnRH antagonist protocol

You may not qualify if:

  • Poor responders
  • Women with 25 or more follicles on the day of trigger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eugonia

Athens, 11528, Greece

Location

Related Publications (2)

  • Revelli A, Poso F, Gennarelli G, Moffa F, Grassi G, Massobrio M. Recombinant versus highly-purified, urinary follicle-stimulating hormone (r-FSH vs. HP-uFSH) in ovulation induction: a prospective, randomized study with cost-minimization analysis. Reprod Biol Endocrinol. 2006 Jul 18;4:38. doi: 10.1186/1477-7827-4-38.

    PMID: 16848893BACKGROUND

  • Al-Inany HG, Aboulghar M, Mansour R, Proctor M. Recombinant versus urinary human chorionic gonadotrophin for ovulation induction in assisted conception. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003719. doi: 10.1002/14651858.CD003719.pub2.

    PMID: 15846677BACKGROUND

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

Study Officials

  • Tryfon Lainas, PhD

    Eugonia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2006

First Posted

December 25, 2006

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Study Completion

July 1, 2016

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations

GR(1)