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.
Conditions
Interventions
Trade Name: Femar
Product Name: Femar
Pharmaceutical Form: Tablet
Sponsors
Fertility clinic Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria; Normogonadotropic, healthy women =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: OBJECTIVES: To evaluate effects of late luteal phase androgen priming to enhance follicle growth and improve sensitivity to FSH stimulation in normogonadotropic women with a proven poor response to standard hormone stimulation for IVF. Each patient thus serves as her own control ;Secondary Objective: SECONDARY ENDPOINTS: To evaluate the effects of this hormonal regime on ovarian androgen production and follicular development by measuring the following parameters 1) on cycle day 24 (start of treatment), 2) on the day of administration of aromatase inhibitor and hCG, and 3) five days later, i.e. on FSH stimulation day 1: I) Concentrations of androstenedione, testosterone, anti-müllerian hormone (AMH), Inhibin B, østradiol, FSH, LH in the circulation. II) Number of antral follicles with diameter = 2mm as visualized by vaginal ultrasound on the three occasions 1), 2) and 3) mentioned above In addition: III) The follicular development; number of follicles > 10mm, > 14 mm and > 17 mm on S8, HCG- and OPU-day. IV) Se-oestradiol per follicle > 10 mm on S8, hCG-day and OPU-day. V) Total consumption of FSH and LH VI) Rate of biochemical and clinical pregnancy ;Primary end point(s): PRIMARY ENDPOINTS: Number of oocytes retrieved and fertilised, and number of transferable embryos in comparison with the patient’s immediate previous IVF cycle, in which a low response was recorded. | — |
Countries
Denmark
Outcome results
None listed