György S Siklósi1, Ferenc G Bánhidy, Nándor Ács. 1. 2nd Department of Obstetrics and Gynecology, Semmelweis University, Budapest, Ulloi ut 78/a, Budapest 1082, Hungary.
Abstract
PURPOSE: To re-evaluate the role of folliculo-luteal function (FLF) in recurrent miscarriage (RM) on the basis of new hormonal diagnostic criteria. METHODS: A prospective, randomized, single-blinded, placebo-controlled study was carried out at 110 apparently healthy patients with three or more miscarriages not related to any presumable predisposing factors of RM were investigated. In the treatment group FLF was normalized preconceptionally. Women in the control group received placebo. FLF was regarded as physiological when the mean of three progesterone (P) values measured every second day between the 4th and 9th day after ovulation or before menstruation was 21.0 ± 2.0 ng/ml. RESULTS: A significant difference (p < 0.001) was found between the physiological and placebo groups in the occurrence of live births: 93 versus 56 %, pregnancy losses: 7 versus 44 %; premature delivery per births: 10 versus 57 %. Luteal mean P and estradiol values were significantly (p < 0.001) different in cases of spontaneous abortions and premature and mature deliveries, respectively (P: 14.6 ± 2.2, 20.2 ± 2.7, 27.6 ± 3.9 ng/ml). A strong and significant correlation (p < 0.001) was found between luteal mean P values and the duration of pregnancy (r = 0.85), as well as between the P means measured in the luteal phase and different parameters of the newborns: weight (r = 0.89), weight percentile (0.86) and length (0.73). Retrospective analysis of our data suggests that a luteal P mean value of 29.3 ± 2.9 ng/ml characterising patients with singular, mature, eutroph newborns seems to be the most favorable P value for successful reproduction in RM. CONCLUSION: Determining the oocyte quality and placentation, FLF quantitatively determines the outcome of pregnancy: its duration and different characteristics of the newborns in RM.
RCT Entities:
PURPOSE: To re-evaluate the role of folliculo-luteal function (FLF) in recurrent miscarriage (RM) on the basis of new hormonal diagnostic criteria. METHODS: A prospective, randomized, single-blinded, placebo-controlled study was carried out at 110 apparently healthy patients with three or more miscarriages not related to any presumable predisposing factors of RM were investigated. In the treatment group FLF was normalized preconceptionally. Women in the control group received placebo. FLF was regarded as physiological when the mean of three progesterone (P) values measured every second day between the 4th and 9th day after ovulation or before menstruation was 21.0 ± 2.0 ng/ml. RESULTS: A significant difference (p < 0.001) was found between the physiological and placebo groups in the occurrence of live births: 93 versus 56 %, pregnancy losses: 7 versus 44 %; premature delivery per births: 10 versus 57 %. Luteal mean P and estradiol values were significantly (p < 0.001) different in cases of spontaneous abortions and premature and mature deliveries, respectively (P: 14.6 ± 2.2, 20.2 ± 2.7, 27.6 ± 3.9 ng/ml). A strong and significant correlation (p < 0.001) was found between luteal mean P values and the duration of pregnancy (r = 0.85), as well as between the P means measured in the luteal phase and different parameters of the newborns: weight (r = 0.89), weight percentile (0.86) and length (0.73). Retrospective analysis of our data suggests that a luteal P mean value of 29.3 ± 2.9 ng/ml characterising patients with singular, mature, eutroph newborns seems to be the most favorable P value for successful reproduction in RM. CONCLUSION: Determining the oocyte quality and placentation, FLF quantitatively determines the outcome of pregnancy: its duration and different characteristics of the newborns in RM.