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Human Chorionic Gonadotropin Supplementation Prior to In-vitro Fertilization Treatment in Poor Responders

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ClinicalTrials.gov Identifier: NCT01205009
Recruitment Status : Unknown
Verified September 2010 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : September 20, 2010
Last Update Posted : March 2, 2011
Sponsor:
Information provided by:

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.

Condition or disease Intervention/treatment
Infertility Drug: Ovitrelle

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2011
Estimated Primary Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Ovitrelle supplemantation
The women will be given 250 mcg of Ovitrelle prior to their IVF cycle
Drug: Ovitrelle
One dose of Ovitrelle 250 mcg
No Intervention: no Ovitrelle supplementation


Outcome Measures

Primary Outcome Measures :
  1. number of oocytes retrieved [ Time Frame: 1 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women >39 years on IVF treatment

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01205009


Contacts
Contact: Mushira Aboo Dia, , MD mushiraa@gmail.com
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Center Not yet recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    0097226776095    arik@hadassah.org.il   
Contact: Mushira Aboo Dia, MD    0097226776425    mushiraa@gmail.com   
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Mushira Aboo Dia, MD Hadassah Medical Center
More Information

Responsible Party: Arik Tzukert, Hadassah Medical Center
ClinicalTrials.gov Identifier: NCT01205009     History of Changes
Other Study ID Numbers: hCGpoorresp-HMO-CTIL
First Posted: September 20, 2010    Key Record Dates
Last Update Posted: March 2, 2011
Last Verified: September 2010

Keywords provided by Hadassah Medical Organization:
in-vitro fertilization
poor responders
human chorionic gonadotropin
Fertility Agents, Female

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs