Human Chorionic Gonadotropin (hCG) Priming Prior to Controlled Ovarian Hyperstimulation (COH) in Poor Responder In Vitro Fertilization (IVF) Patients
APPE
hCG Priming Prior to COH in Poor Responder IVF Patients
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2008
1 active site
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
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 25, 2008
CompletedFirst Posted
Study publicly available on registry
March 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedApril 22, 2015
April 1, 2015
1.9 years
October 25, 2008
April 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pregnancy rate
2 weeks after intervention
Secondary Outcomes (1)
number of oocytes retrieved
2 weeks after intervention
Study Arms (2)
hCG
ACTIVE COMPARATOR200 IU rec hCG s.c./5 days, 4 doses prior to onset of COH
placebo
PLACEBO COMPARATORsimilar injection at same time points with similar diluent but no hCG
Interventions
Eligibility Criteria
You may qualify if:
- previous IVF cycle with 5 or less mature follicles or 5 or less oocyte retrieved
You may not qualify if:
- years or older
- BMI \<18 or \>30
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IVI Madridlead
Study Sites (1)
IVI-Madrid
Madrid, 28023, Spain
Related Publications (2)
Balasch J, Fabregues F, Penarrubia J, Carmona F, Casamitjana R, Creus M, Manau D, Casals G, Vanrell JA. Pretreatment with transdermal testosterone may improve ovarian response to gonadotrophins in poor-responder IVF patients with normal basal concentrations of FSH. Hum Reprod. 2006 Jul;21(7):1884-93. doi: 10.1093/humrep/del052. Epub 2006 Mar 3.
PMID: 16517559BACKGROUNDMassin N, Cedrin-Durnerin I, Coussieu C, Galey-Fontaine J, Wolf JP, Hugues JN. Effects of transdermal testosterone application on the ovarian response to FSH in poor responders undergoing assisted reproduction technique--a prospective, randomized, double-blind study. Hum Reprod. 2006 May;21(5):1204-11. doi: 10.1093/humrep/dei481. Epub 2006 Feb 13.
PMID: 16476678BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juan A Garcia-Velasco, MD, PhD
IVI Madrid
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2008
First Posted
March 26, 2009
Study Start
October 1, 2008
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
April 22, 2015
Record last verified: 2015-04