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

I

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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