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Crinone:New FDA Approved Vaginal Progesterone
Title: Transvaginal administration of progesterone
Authors: R. Fanchin et al.
Address:Paris, France
Source: Obstetrics and Gynecology 90: 396-401 (September) 1997
Summary: Sequential administration of estradiol (E2) and progesterone in physiological doses has been shown to induce normal secretory transformation of the endometrium in women whose ovaries are absent or inactive. This study uses recipients undergoing cycle programming for oocyte donation as an experimental model to examine the hormonal control of endometrial morphology. Three different doses of vaginal progesterone (Crinone) were given every other day from days 15-27 to 40 women 25-41 years of age. Group A(n=14) received progesterone 45 mg, group B (n=13) 90 mg. and group C(n= 13) 180 mg. Measurements of plasma gonadotropins, estrone, E2, and progesterone were performed along with an endometrial biopsy on day 20 (n=20) or day 24 (n=20) for endometrial dating and for estrogen and progesterone receptor determinations. The results showed estrogen levels to be within the menstrual cycle range. Group A mean progesterone levels were the lowest of the three groups (2.4+0.2 ng/ml). Group B plasma progesterone was the highest (3.6 +0.2 ng/ml). Group C plasma progesterone was 3.4+0.2 ng/ml(P=less than.005). All three groups showed normal transformation in the glands (day 20) and stroma (Day 24). The authors conclude that this progesterone induced normal secretory transformation of the endometrium suggests a direct vagina to uterus transit or first pass effect and that the vaginal route may be a better way to administer other uterotrophic substances maximizing uterine effects and minimizing systemic levels.
Comment: It seems clear from this and other studies that vaginal progesterone has a direct, non-systemic uterine effect. Normal endometrial changes are seen when plasma levels of progesterone are lower than what is thought necessary to achieve normal response. Since oral synthetic progestins are probably contraindicated in assisted reproduction and progesterone itself is poorly absorbed orally, a variety of administration routes have been tried. Injections of progesterone hurt. Some centers are administering the micronized progesterone (oral gel-caps) by vaginal route minimizing the mess of the vaginal suppositories. Crinone appears to be a clearly superior preparation that is approved only for assisted reproduction at present. Unfortunately its high cost, $8-20 per day, will prevent its widespread use for other indications. Progesterone, rather than synthetic progestins, may be superior in standard hormone replacement regimens. It is too bad that little data is available on its long term use and endometrial hyperplasia. Hopefully, large trlals will be forthcoming on the use of natural progesterone for hormone replacement indications.