Efficacy of Luteinizing Hormone (LH) Activity in Low Responder Patients With Transdermal Testosterone

Condition(s) targeted: Other Complications Associated With Artificial Fertilization

Intervention: Testosterone and FSHr-LHr (Drug); testosterone and FSHr alone (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Hospital Clinic of Barcelona

The investigators have previously demonstrated the utility of transdermal testosterone in in vitro fertilization (IVF) low responder patients. Now, the investigators want to evaluate the efficacy of luteinizing hormone (LH) activity added to recombinant follicular stimulating hormone (FSHr) during ovarian stimulation in these patients.

Official title: Efficacy of LH Activity in Low Responder Patients With Transdermal Testosterone: a Randomised Controlled Study.

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: ovarian response

Secondary outcome:

clinical pregnancy rate

Implantation rate

Live birth rate

Detailed description: Studies in macaques have indicated that androgens have some synergistic effects with follicular stimulating hormone (FSH) on folliculogenesis. Our previous clinical studies demonstrated the usefulness of pretreatment with transdermal testosterone in low-responder IVF patients. There is controversy on the usefulness of recombinant luteinizing hormone (LHr) added to FSHr in ovarian stimulation of low responder patients. Thus, our present study has been designed to compare ovarian stimulation with FSHr alone versus LHr added to FSHr when transdermal testosterone pretreatment is used.

Minimum age: 18 Years. Maximum age: 41 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Low responder patients: patients with previously canceled cycle or recovery of 3 or

less oocytes Exclusion Criteria:

- FSH > 12

- Previous ovarian surgery

Hospital Clínic, Barcelona 08036, Spain

Related publications:

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.

Starting date: January 2011
Last updated: February 7, 2011