Back to resultsHuman Chorionic Gonadotropin Supplementation Prior to In-vitro Fertilization Treatment in Poor Responders
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ovitrelle
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring in-vitro fertilization, poor responders, human chorionic gonadotropin, Fertility Agents, Female
Eligibility Criteria
Inclusion Criteria:
- women >39 years on IVF treatment
Exclusion Criteria:
- polycystic ovary syndrome
- Any allergy to injection of human chorionic gonadotropin before
Sites / Locations
- Hadassah Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Ovitrelle supplemantation
no Ovitrelle supplementation
Arm Description
The women will be given 250 mcg of Ovitrelle prior to their IVF cycle
Outcomes
Primary Outcome Measures
number of oocytes retrieved
Secondary Outcome Measures
Full Information
NCT ID
NCT01205009
First Posted
August 30, 2010
Last Updated
March 1, 2011
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01205009
Brief Title
Human Chorionic Gonadotropin Supplementation Prior to In-vitro Fertilization Treatment in Poor Responders
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
in-vitro fertilization, poor responders, human chorionic gonadotropin, Fertility Agents, Female
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ovitrelle supplemantation
Arm Type
Active Comparator
Arm Description
The women will be given 250 mcg of Ovitrelle prior to their IVF cycle
Arm Title
no Ovitrelle supplementation
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Ovitrelle
Intervention Description
One dose of Ovitrelle 250 mcg
Primary Outcome Measure Information:
Title
number of oocytes retrieved
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women >39 years on IVF treatment
Exclusion Criteria:
polycystic ovary syndrome
Any allergy to injection of human chorionic gonadotropin before
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mushira Aboo Dia,, MD
Email
mushiraa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mushira Aboo Dia, MD
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
0097226776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Mushira Aboo Dia, MD
Phone
0097226776425
Email
mushiraa@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Human Chorionic Gonadotropin Supplementation Prior to In-vitro Fertilization Treatment in Poor Responders
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