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

Ovarian Response Clinical Trial

— APPE  

Official title:

hCG Priming Prior to COH in Poor Responder IVF Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870025
• Other study ID #: IVIMAD-LO-09-2008-01
• Status: Completed
• Phase: Phase 4
• First received: October 25, 2008
• Last updated: April 21, 2015
• Start date: October 2008
• Est. completion date: September 2010

Study information

• Verified date: April 2015
• Source: IVI Madrid
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 41 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Response

Intervention

Biological:
• human chorionic gonadotropin
200 IU, sc, every 5 days, 4 doses
• placebo
diluent, every 5 days, s.c., 4 doses

Locations

Country	Name	City	State
Spain	IVI-Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
IVI Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Balasch J, Fábregues F, Peñarrubia 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. Epub 2006 Mar 3. — View Citation

Massin 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. Epub 2006 Feb 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy rate		2 weeks after intervention	No
Secondary	number of oocytes retrieved		2 weeks after intervention	No