Androgen priming in the late luteal phase as a mean to improve the outcome of ovarian stimulation for IVF in normogonadotrophic women with a previously proven poor response - Androgen priming

Conditions: Hypothesis. By combining pituitary downregulation with aromatase inhibitor, and hCG injection during a late luteal phase a powerful stimulation of thecal androgen production is achieved. Thereby, it is expected that the later FSH stimulation will result in growth and pre-ovulatory development of significantly more follicles in women with a previously proven poor response to standard hormone treatment in IVF cycles. The present study is designed to meet these requirements.

Registration Number: EUCTR2005-003104-11-DK

Lead Sponsor: Fertility clinic Odense University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 20

Inclusion Criteria

Inclusion criteria; Normogonadotropic, healthy women < 40 years old, who in a previous IVF or ICSI attempt has shown the characteristics of a low responder as defined above.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria;
Any clinically significant systemic disease (e.g., insulin dependent diabetes) or endocrine/metabolic disease, any concomitant medications that would interfere with evaluation of study medications (non-study hormonal therapy - except for thyroid medication, NSAIDs - including aspirin, and psychotropic agents (phenothiazine’s, major tranquillisers) at the time of study entry and during the study.
Abuse of alcohol or drugs, history of chemotherapy or radiotherapy, any clinically relevant abnormal laboratory value, use of any non registered investigational drugs during 3 months before screening or previous participation in the study, pregnancy, lactation or contraindication to pregnancy – must be confirmed by negative pregnancy test on CD 24. i.e. at the time of entry into the study.