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

Fertility clinic Odense University Hospital0 sites20 target enrollmentSeptember 1, 2005

Overview

Phase: Not Applicable
Intervention: Not specified
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.
Sponsor: Fertility clinic Odense University Hospital
Enrollment: 20
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

September 1, 2005

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

Fertility clinic Odense University Hospital

•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;
•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.