ClinicalTrials.gov
ClinicalTrials.gov Menu

Human Chorionic Gonadotropin (hCG) Priming Prior to Controlled Ovarian Hyperstimulation (COH) in Poor Responder In Vitro Fertilization (IVF) Patients (APPE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00870025
Recruitment Status : Completed
First Posted : March 26, 2009
Last Update Posted : April 22, 2015
Sponsor:
Information provided by (Responsible Party):
IVI Madrid

Brief Summary:
There is a decline in androgen concentration with ovarian aging. Also, ovarian response to COH in IVF cycles diminishes with ovarian aging. Recent evidence suggest that testosterone or DHEA may improve ovarian response in poor prognosis patients by increasing intraovarian androgen concentration. A physiological way to induce androgen synthesis within the ovary is to stimulate theca cells androgen production by hCG stimulation. By doing this in the previous cycle we might expect a better response to COH.

Condition or disease Intervention/treatment Phase
Ovarian Response Biological: human chorionic gonadotropin Biological: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: hCG Priming Prior to COH in Poor Responder IVF Patients
Study Start Date : October 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: hCG
200 IU rec hCG s.c./5 days, 4 doses prior to onset of COH
Biological: human chorionic gonadotropin
200 IU, sc, every 5 days, 4 doses
Biological: placebo
diluent, every 5 days, s.c., 4 doses
Placebo Comparator: placebo
similar injection at same time points with similar diluent but no hCG
Biological: placebo
diluent, every 5 days, s.c., 4 doses



Primary Outcome Measures :
  1. pregnancy rate [ Time Frame: 2 weeks after intervention ]

Secondary Outcome Measures :
  1. number of oocytes retrieved [ Time Frame: 2 weeks after intervention ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • previous IVF cycle with 5 or less mature follicles or 5 or less oocyte retrieved

Exclusion Criteria:

  • 42 years or older
  • BMI <18 or >30

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): NCT00870025


Locations
Spain
IVI-Madrid
Madrid, Spain, 28023
Sponsors and Collaborators
IVI Madrid
Investigators
Principal Investigator: Juan A Garcia-Velasco, MD, PhD IVI Madrid