Oral dydrogesterone versus vaginal progesterone gel in the luteal phase support: randomized controlled trial. 2015

Vlatka Tomic, and Jozo Tomic, and Djurdja Zigmundovac Klaic, and Miro Kasum, and Krunoslav Kuna
Department of Gynecology and Obstetrics, University Clinical Centre "Sisters of Mercy", Zagreb, Croatia; Department of Gynecology and Obstetrics, DZ Zagreb Centar, Zagreb, Croatia. Electronic address: tomic.vlatka@gmail.com.

OBJECTIVE To compare efficacy, satisfaction and tolerability of oral dydrogesterone and micronized vaginal progesterone gel used for luteal supplementation. METHODS Randomized controlled trial. A total of 853 infertile women undergoing IVF/ICSI treatment in University Hospital Center "Sisters of Mercy", Zagreb, Croatia. Luteal support was provided as Crinone 8%(®) vaginal progesterone gel (90mg) administered daily, or oral dydrogesterone Duphaston(®) (2× 10mg) administered two times daily. Progesterone was administered from the day of oocyte retrieval (day 0) till pregnancy test or in a case of pregnancy, until week 10. RESULTS The on-going pregnancy rates were comparable between Crinone 8%(®) vaginal progesterone gel and oral dydrogesterone - Duphaston(®) (28.1% versus 30.3%; OR 1.11 (0.82-1.49 with 95% CI)). Overall satisfaction and tolerability were significantly higher in the dydrogesterone group than in the Crinone group. Vaginal bleeding, interference with coitus and local adverse side effects such as vaginal irritation and discharge occurred significantly more in Crinone group than in dydrogesterone group. CONCLUSIONS Oral dydrogesterone is effective drug, well tolerated and accepted among patients and can be considered for routine luteal support. BACKGROUND NCT01178931; www.clinicaltrials.gov.

UI MeSH Term Description Entries
D007247 Infertility, Female Diminished or absent ability of a female to achieve conception. Sterility, Female,Sterility, Postpartum,Sub-Fertility, Female,Subfertility, Female,Female Infertility,Female Sterility,Female Sub-Fertility,Female Subfertility,Postpartum Sterility,Sub Fertility, Female
D008183 Luteal Phase The period in the MENSTRUAL CYCLE that follows OVULATION, characterized by the development of CORPUS LUTEUM, increase in PROGESTERONE production by the OVARY and secretion by the glandular epithelium of the ENDOMETRIUM. The luteal phase begins with ovulation and ends with the onset of MENSTRUATION. Menstrual Cycle, Luteal Phase,Menstrual Cycle, Secretory Phase,Menstrual Secretory Phase,Postovulatory Phase,Phase, Luteal,Phase, Postovulatory,Secretory Phase, Menstrual
D011247 Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. Gestation,Pregnancies
D011372 Progestins Compounds that interact with PROGESTERONE RECEPTORS in target tissues to bring about the effects similar to those of PROGESTERONE. Primary actions of progestins, including natural and synthetic steroids, are on the UTERUS and the MAMMARY GLAND in preparation for and in maintenance of PREGNANCY. Gestagenic Agent,Progestagen,Progestagenic Agent,Progestational Agent,Progestational Compound,Progestational Hormone,Progestogen,Progestogens,Gestagen,Gestagen Effect,Gestagen Effects,Gestagenic Agents,Gestagenic Effect,Gestagenic Effects,Gestagens,Progestagenic Agents,Progestagens,Progestational Agents,Progestational Compounds,Progestational Hormones,Progestin,Progestin Effect,Progestin Effects,Progestogen Effect,Progestogen Effects,Agent, Gestagenic,Agent, Progestagenic,Agent, Progestational,Compound, Progestational,Effect, Gestagen,Effect, Gestagenic,Effect, Progestin,Effect, Progestogen,Effects, Gestagen,Effects, Gestagenic,Effects, Progestin,Effects, Progestogen,Hormone, Progestational
D011374 Progesterone The major progestational steroid that is secreted primarily by the CORPUS LUTEUM and the PLACENTA. Progesterone acts on the UTERUS, the MAMMARY GLANDS and the BRAIN. It is required in EMBRYO IMPLANTATION; PREGNANCY maintenance, and the development of mammary tissue for MILK production. Progesterone, converted from PREGNENOLONE, also serves as an intermediate in the biosynthesis of GONADAL STEROID HORMONES and adrenal CORTICOSTEROIDS. Pregnenedione,Progesterone, (13 alpha,17 alpha)-(+-)-Isomer,Progesterone, (17 alpha)-Isomer,Progesterone, (9 beta,10 alpha)-Isomer
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D004394 Dydrogesterone A synthetic progestational hormone with no androgenic or estrogenic properties. Unlike many other progestational compounds, dydrogesterone produces no increase in temperature and does not inhibit OVULATION. Isopregnenone,6-Dehydro-9 beta-10 alpha-progesterone,Dehydrogesterone,Duphaston,6 Dehydro 9 beta 10 alpha progesterone
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man

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