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

This study has been completed.
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier:
NCT00870025
First received: October 25, 2008
Last updated: March 16, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Ovarian Response
Biological: human chorionic gonadotropin
Biological: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: hCG Priming Prior to COH in Poor Responder IVF Patients

Resource links provided by NLM:


Further study details as provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:

Primary Outcome Measures:
  • pregnancy rate [ Time Frame: 2 weeks after intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • number of oocytes retrieved [ Time Frame: 2 weeks after intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 41 Years
Genders 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00870025

Locations
Spain
IVI-Madrid
Madrid, Spain, 28023
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
Investigators
Principal Investigator: Juan A Garcia-Velasco, MD, PhD IVI Madrid
  More Information

Publications:
Responsible Party: Juan A Garcia-Velasco, IVI-Madrid
ClinicalTrials.gov Identifier: NCT00870025     History of Changes
Other Study ID Numbers: IVIMAD-LO-09-2008-01
Study First Received: October 25, 2008
Last Updated: March 16, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:
androgens
hCG
low response
IVF
Ovarian response in women with previous low response

Additional relevant MeSH terms:
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014