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

IVI Madrid

Status and phase: Completed; Phase 4

Conditions: Ovarian Response

Treatments: Biological: human chorionic gonadotropin; Biological: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00870025

IVIMAD-LO-09-2008-01

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18 to 41 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

hCG

Active Comparator group

Description:

200 IU rec hCG s.c./5 days, 4 doses prior to onset of COH

Treatment:

Biological: placebo

Biological: human chorionic gonadotropin

placebo

Placebo Comparator group

Description:

similar injection at same time points with similar diluent but no hCG

Treatment:

Biological: placebo