NCT01205009

Brief Summary

In an era of delayed fertility plans, there is increasing need for fertility treatment in older women with poor response. Human chorionic gonadotropin (hCG) supplementation prior to treatment, as a thecal stimulant, may improve folliculogenesis and ovarian response.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2010

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 20, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Last Updated

March 2, 2011

Status Verified

September 1, 2010

Enrollment Period

11 months

First QC Date

August 30, 2010

Last Update Submit

March 1, 2011

Conditions

Infertility

Keywords

in-vitro fertilizationpoor respondershuman chorionic gonadotropinFertility Agents, Female

Outcome Measures

Primary Outcomes (1)

  • number of oocytes retrieved

    1 month

Study Arms (2)

Ovitrelle supplemantation

ACTIVE COMPARATOR

The women will be given 250 mcg of Ovitrelle prior to their IVF cycle

Drug: Ovitrelle

no Ovitrelle supplementation

NO INTERVENTION

Interventions

OvitrelleDRUG

One dose of Ovitrelle 250 mcg

Ovitrelle supplemantation

Eligibility Criteria

Age40 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women \>39 years on IVF treatment

You may not qualify if:

  • polycystic ovary syndrome
  • Any allergy to injection of human chorionic gonadotropin before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel, Israel

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

Study Officials

  • Mushira Aboo Dia, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mushira Aboo Dia,, MD

CONTACT

mushiraa@gmail.com

Hadas Lemberg, PhD

CONTACT

00 972 2 6777572lhadas@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2010

First Posted

September 20, 2010

Study Start

April 1, 2011

Primary Completion

March 1, 2012

Last Updated

March 2, 2011

Record last verified: 2010-09

Locations

IL(1)