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ABSTRACT: The aim of this study was to characterize the ovarian primordial and nongrowing follicle number according to the Stages of Reproductive Aging Workshop (STRAW) staging system as defined by menstrual cycle characteristics.
Normal ovaries were collected from 63 women (age 26-52 y) undergoing oophorectomy for benign indications. Before surgical operation, each participant completed a detailed questionnaire collecting information regarding menstrual cycle characteristics and was classified by bleeding patterns into STRAW stages -4, -3, -2, and -1. A single ovary was selected for the determination of ovarian primordial and total nongrowing follicle number using a validated fractionator/optical disector method. A subset of the participants (n = 43) underwent transvaginal ultrasound examination for the determination of the ovarian antral follicle count and serum measurements of follicle-stimulating hormone, estradiol, antimüllerian hormone, and inhibin B. All measurements were obtained within 2 weeks of surgical operation, irrespective of cycle day.
Significant differences were identified in ovarian primordial (P < 0.0001) and nongrowing follicle (P < 0.0001) counts across the STRAW stages. In post hoc testing, the differences in primordial follicle counts were significant between each of the STRAW stages. Significant differences were also identified in serum levels of antimüllerian hormone, follicle-stimulating hormone, and ovarian antral follicle count across the STRAW stages.
Progression through the STRAW stages as defined by menstrual cycle characteristics is associated with progressive and significant decreases in the ovarian primordial follicle number.
Menopause (New York, N.Y.) 12/2011; 19(2):164-71. · 3.08 Impact Factor
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ABSTRACT: To compare a US clinical trial of gonadotropin therapy for IVF with a similar European trial to determine what factors may explain the higher clinical pregnancy rate in the US trial.
Comparison of baseline, treatment, and outcome variables in the United States (US) and European trials.
IVF practices in the US (n=4) and Europe (n=6).
297 women undergoing IVF.
None.
Clinical pregnancy rate.
Clinical pregnancy rates were 43.4% in the US compared with 29.7% in Europe (p=0.016), with a live birth rate of 38.2% versus 27.6% (p=0.064). This difference in clinical pregnancy rate could not be explained by differences in the US versus Europe for number of embryos transferred (2.3 vs. 2.6) or female age (34.6 vs. 30.4). Although the starting dose of gonadotropin was higher in the US trial compared with the European trial (300 versus 225 IU), the total dose of gonadotropin was only slightly higher in the US. In multiple logistic regression analysis of 81 pretransfer variables on clinical pregnancy, the only two found to be significant predictors of outcome were baseline endometrial thickness following down-regulation and number of days of gonadotropin treatment.
This study suggests the possibility that US pregnancy rates may be higher in part because of differences in down-regulation or gonadotropin dosing. Other factors not assessed in these studies or in national datasets likely also contribute to the difference in pregnancy rates.
Fertility and sterility 10/2009; 94(4):1287-91. · 3.97 Impact Factor
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Fertility and sterility 05/2008; 89(4):1028-9; author reply 1029. · 3.97 Impact Factor
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ABSTRACT: The primary determinant of reproductive age in women is the number of ovarian non-growing (primordial, intermediate and primary) follicles (NGFs). To better characterize the decline in NGF number associated with aging, we have employed modern stereology techniques to determine NGF number in women from birth to menopause.
Normal human ovaries were collected from 122 women (aged 0-51 years) undergoing elective oophorectomy, organ donation or autopsy. After gross pathologic examination, systematic random sampling was utilized to obtain tissue for analysis by the fractionator/optical disector method. Models to describe the resulting decay curve were constructed and evaluated.
NGF decay was best described by a simple power function: log (y) = ax(b) + c, where a, b and c are constants and y = NGF count at age x (R(2) = 0.84, Sums of Squares Error = 28.18 on 119 degrees of freedom). This model implies that follicles decay faster with increasing age.
Unlike previous models of ovarian follicle depletion, our model predicts no sudden change in decay rate, but rather a constantly increasing rate. The model not only agrees well with observed ages of menopause in women, but also is more biologically plausible than previous models. Although the model represents a significant improvement compared with earlier attempts, a considerable percentage of the variation in NGF number between women cannot be explained by age alone.
Human Reproduction 04/2008; 23(3):699-708. · 4.47 Impact Factor
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ABSTRACT: To compare the efficacy of highly purified human urinary follicle stimulating hormone (HP-hFSH) versus human recombinant follitropin-alpha (rFSH) in volunteers undergoing controlled ovarian stimulation for IVF.
A randomized, controlled, investigator-blind trial.
Four assisted reproductive technology centers.
One hundred fifty-two IVF patients.
Volunteers, aged 18-39, were randomized to HP-hFSH (n = 76) versus rFSH (n = 76) at a starting dose of 300 IU in down-regulated cycles.
Number of oocytes, clinical pregnancy rate, and live birth rate with HP-hFSH versus rFSH.
The total IU of gonadotropin used did not differ between the two groups. There was no difference in number of oocytes retrieved with HP-hFSH (mean = 16.3) compared with rFSH (mean = 17.1), confidence interval (CI) of difference = -3.79 to +2.18. Clinical pregnancy rate, as defined by the presence of a gestational sac, was 48.7% (CI = 37.0%-60.4%) with HP-hFSH versus 44.7% (CI = 33.3%-56.6%) with rFSH (CI of difference = -11.9% to +19.8%). Live birth rate was 38.2% (29 of 76) in both groups (CI = 27.2%-50.0%), for a difference between groups of 0.0% (CI of the difference = -15.4% to +15.4%).
There were no statistically significant differences in mean oocyte number, clinical pregnancy rate, or live birth rate between HP-hFSH versus rFSH.
Fertility and sterility 04/2008; 91(4):1005-11. · 3.97 Impact Factor
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ABSTRACT: Inhibin is a gonadal glycoprotein believed to be important in the regulation of pituitary FSH secretion and/or to function as a paracrine factor within the ovary and testis. We studied serum levels of inhibin, oestradiol (E2), progesterone (P), FSH and LH during the periovulatory interval in order to determine whether there is differential control of sex steroid and inhibin secretion by the mature follicle and the emerging corpus luteum. Seven normal cyclic women were admitted 3–4 days prior to midcycle and blood samples drawn every 3 h for 5–7 days. Serum E2, P, FSH, LH and inhibin were measured by radioimmunoassay. Data were normalized around the peak LH value (0 h). Serum E2 and inhibin rose in parallel (r = 0.92, P < 0.001) between – 69 and – 18 h, E2 reached a peak of 1296 ± 154 (mean±SEM) pmol/1 at −18 h, then fell to 1050± 139 pmol/1 at 0 h. Serum inhibin, on the other hand, continued to rise to a peak of 837±95U/lat – 6 h, fell to 455±48 U/lat +45 h, then rose again. On average, the peak inhibin level occurred 10.4± 5.1 h after the peak E2 (P < 0.05). Inhibin levels were positively correlated with both serum LH and FSH between – 24 and +24 h (P<0.01). Serum E2 was negatively correlated with LH, FSH and inhibin between – 24 and 0 h (P < 0.01). Serum P levels increased from 1.8 ± 0.3 nmol/1 at – 24 h to 14.3 ± 1.0 nmol/1 at +60 h. Serum inhibin was positively correlated with serum P from −24 to 0 h (P<0.01) and +45 to +60 h (P < 0.01), but was inversely correlated from 0 to +45 h(P< 0.01). We conclude that the maturing follicle secretes both E2 and inhibin in parallel until – 18 h, at which time the process of luteinization is initiated by the onset of the midcycle LH surge, as evidenced by the rise in P. E2 secretion then falls while inhibin secretion rises, indicating different regulation of secretion of these two hormones by the maturing follicle. Furthermore, the close positive correlation between inhibin and gonadotrophin levels around midcycle suggests that FSH and/or LH stimulate inhibin secretion and that the presumed negative feedback effect of inhibin on FSH secretion is overcome at this time. After midcycle, inhibin secretion initially falls, then rises, while P rises progressively. This transient divergence of P and inhibin secretion may occur during the transformation of the preovulatory follicle into the corpus luteum.
Clinical Endocrinology 03/2008; 32(1):39 - 48. · 3.17 Impact Factor
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ABSTRACT: BACKGROUND Previous published reports on the number of non-growing follicles (NGFs) in the human ovary have employed model-based methods for number estimates. These methods are time-intensive, and require correction factors and assumptions that ultimately limit their accuracy. Here, we describe the modification, application and validation of a modern fractionator/optical disector technique for the estimation of human ovarian NGF number. METHODS Forty-eight pairs of normal human ovaries were collected from women (age 8-51 years) undergoing elective bilateral oophorectomy, organ donation, or from autopsy. After gross pathologic examination, systematic random sampling was utilized to obtain tissue for analysis by the fractionator/optical disector method. The precision of individual NGF counts was determined by calculating the observed coefficient of error (OCE). Intra-observer variability and variation in NGF number between ovaries within a pair were also determined. RESULTS The mean OCE was 16.6% with larger variations observed at lower follicle counts. In recount experiments of the same ovary, NGF number estimates varied by 15-29%, except at very low follicle counts where variation was greater, but absolute differences were small. There was no significant difference in NGF number between ovaries within a pair (Wilcoxon signed rank test, P = 0.81). CONCLUSIONS Modern stereology methods provide an unbiased, efficient method for estimating NGF number in the human ovary. Both ovaries within a pair contain similar numbers of NGFs.
Human Reproduction 09/2007; 22(8):2103-10. · 4.47 Impact Factor
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Melissa A Parisi,
Linda A Ramsdell,
Mark W Burns,
Michael C Carr,
Richard E Grady,
Daniel F Gunther,
Gadi B Kletter,
Elizabeth McCauley,
Michael E Mitchell,
Kent E Opheim,
Catherine Pihoker,
Gail E Richards, Michael R Soules,
Roberta A Pagon
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ABSTRACT: To describe a Gender Assessment Team that has provided a multidisciplinary approach to the diagnosis, medical and surgical treatment, genetic counseling, and psychosocial support of patients with ambiguous genitalia, intersex disorders, and other genital anomalies, collectively termed disorders of sex development; and to determine the major diagnostic categories and approach.
A retrospective review of 250 patients evaluated by the Team at Children's Hospital and Regional Medical Center in Seattle, WA, from January 1981 through December 2005. The Team included the following specialties: medical genetics, cytogenetics, gynecology, pediatric urology, endocrinology, and psychiatry.
Of the subjects, 177 were infants, 46 were children or adolescents, and 27 had a multisystem genetic condition. The most common diagnoses were congenital adrenal hyperplasia (14%), androgen insensitivity syndrome (10%), mixed gonadal dysgenesis (8%), clitoral/labial anomalies (7%), hypogonadotropic hypogonadism (6%), and 46,XY small-for-gestational-age males with hypospadias (6%).
The six most common diagnoses comprised 50% of the cohort. The expertise of a multidisciplinary team allowed for integrated care for patients with disorders of sex development and identification of novel conditions. Geneticists play an important role in a team approach through knowledge of genetic testing options and diagnosis of patients with karyotypic abnormalities and syndromes with genital anomalies.
Genetics in Medicine 07/2007; 9(6):348-57. · 4.76 Impact Factor
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ABSTRACT: We developed assays for measurement of urinary betaLH and betaFSH under collection and storage conditions typical of non-clinical research settings.
IEMAs for free betaLH and total betaFSH were validated by standard methods. Stability of urinary betaLH and betaFSH was tested across freeze-thaws and stored long term at 4 degrees C or -20 degrees C, or short term at room temperature, and with heating to dissociate the subunits.
The IEMAs exhibited acceptable parallelism, specificity, recovery (averaging 100% for betaLH, 97% for betaFSH), imprecision (maximum within-run and between run CVs, respectively, 4.8% and 25.7% for betaLH, 5.6% and 17.0% for betaFSH), and minimum detectable dose (2.5 pmol/L for betaLH, 6.8 pmol/L for betaFSH). Urine and serum measures were highly correlated (r=0.95 for LH, 0.86 for FSH). There was no consistent decline with any storage type. Dissociation of subunits by heating was needed for betaLH, but not betaFSH.
These IEMAs measure free betaLH and total betaFSH, overcoming inter-individual variability in, and collection and storage effects on, subunit dissociation, without the need for urine preservatives.
Clinical Biochemistry 12/2006; 39(11):1071-9. · 2.08 Impact Factor
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Michael R Soules
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ABSTRACT: The author perceives that there has been a shift away from academics and toward private practice in reproductive endocrinology and infertility over the last 25 years. It has been difficult to integrate assisted reproductive technology into academic medicine in the United States.
Fertility and sterility 10/2005; 84(3):570-2. · 3.97 Impact Factor
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ABSTRACT: Serum FSH elevations and decreases in inhibin B have been consistently demonstrated in the early follicular phase of cycles in women of advanced reproductive age. However, secretory products of the dominant follicle (estradiol and inhibin A) in the serum of older ovulatory women are maintained at levels similar to those of their younger counterparts. The goal of this investigation was to determine if ovarian secretory capacity is dependent on relative FSH levels and if basal measures of ovarian reserve reflect ovarian secretory capacity.
We administered equivalent low, but effective doses of recombinant FSH for 5 days to a group of older subjects (40-45 years, n=9) and younger controls (20-25 years, n=10) after pituitary suppression with a GnRH agonist. Outcome measures included follicular development as determined by serial transvaginal ultrasound examinations and serum levels of estradiol, inhibin A and inhibin B.
Serum levels of estradiol and inhibin A were not statistically different between the two groups, while the number of large follicles formed was greater in the younger subjects. Basal parameters of ovarian reserve were not significantly correlated with ovarian secretory capacity, but did correlate with the number of follicles recruited in response to low-dose FSH.
By providing equivalent serum levels of FSH in older and younger reproductive aged women, this study demonstrates that the secretory capacity of recruited follicles is maintained in older reproductive aged women.
Human Reproduction 02/2005; 20(1):89-95. · 4.47 Impact Factor
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ABSTRACT: The objective of this study was 2-fold. The first was to estimate side-to-side variation in antral follicle counts. The second was to determine whether basal follicle-stimulating hormone levels on days 2, 3, and 4 of the same menstrual cycle are significantly different.
Forty-one patients between the ages of 20 and 42 years undergoing monitoring for in vitro fertilization-embryo transfer were evaluated ultrasonographically for antral follicle number. The antral follicle counts were determined for each ovary by experienced ultrasonographers at the time of suppression check ultrasonography. In a separate study, 62 normal subjects (ages 20-25 and 40-45 years) underwent serial sequential serum follicle-stimulating hormone determinations on days 2-4 of the menstrual cycle, and these levels were compared.
There was no significant difference between right and left antral follicle counts (P =.30). Serial follicle-stimulating hormone values were not significantly different on days 2, 3, or 4 of the menstrual cycle (P =.22).
There is no significant difference between right-sided and left-sided antral follicle counts within the same individual. In turn, there is no significant difference in serial follicle-stimulating hormone levels on days 2, 3, or 4 of the menstrual cycle.
III
Obstetrics and Gynecology 11/2004; 104(4):801-4. · 4.73 Impact Factor
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ABSTRACT: To compare the value of basal follicle-stimulating hormone (FSH) measurement vs. the clomiphene citrate challenge test (CCCT) in predicting the ability to achieve a pregnancy in women who are undergoing infertility treatment.
Meta-analysis.
All studies that evaluated either basal FSH or the CCCT for determining the likelihood of pregnancy.
Infertility population undergoing treatment, which was defined as patients undergoing ovulation induction, IUI, or in vitro fertilization (IVF).
None.
Diagnostic test characteristics were calculated and pooled using standard methods. Inability to achieve a pregnancy with treatment was considered as the "disease."
Twelve studies on basal FSH (with 6296 patients, mean age 33.8) and seven studies on the CCCT (with 1352 patients, mean age 34.5) fit our criteria and were analyzed. For basal FSH and the CCCT, the sensitivities were 6.6% (95% confidence interval [CI] 5.9, 7.3%) and 25.9% (95% CI 23.0, 29.0%), respectively, and specificities were 99.6% (95% CI 99.1, 99.9%) and 98.1% (95% CI 96.5, 99.1%), respectively. For "disease" prevalence ranging from 40%-100%, for basal FSH and the CCCT, the positive predictive values ranged from 91.7%-100% and 90.1%-100%, respectively, and negative predictive values ranged from 61.5%-0.0% and 66.5%-0.0%, respectively.
Basal FSH and the CCCT are similar in predicting the ability to achieve a clinical pregnancy in women undergoing infertility treatment. With either test, a normal result is not useful, but an abnormal result virtually confirms that pregnancy will not occur with treatment.
Fertility and Sterility 08/2004; 82(1):180-5. · 3.56 Impact Factor
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ABSTRACT: Previous studies have reported that the monotropic rise in FSH in older women is associated with decreased inhibin B and/or A levels and increased levels of activin A. Whereas most investigators have found decreased follicular-phase inhibin B, the roles of inhibin A and activin A as modulators of the FSH rise are unclear. The objectives of this study were to determine whether deficiencies in circulating levels of inhibin A, inhibin B, and/or activin A exist during the intercycle interval in ovulatory older (age, 40-45 yr; n = 16), compared with younger women (age, 20-25 yr; n = 13). Blood samples were obtained daily throughout one menstrual cycle and the follicular phase of the subsequent cycle and were analyzed for LH, FSH, estradiol, inhibin A and B, and activin A. Despite significant FSH elevation, no deficiencies in inhibin A, activin A, or estradiol were detected in older subjects. In fact, inhibin A was significantly higher in older participants during the intercycle phase (P = 0.01), whereas inhibin B was significantly lower. Thus, the monotropic rise in FSH does not appear to result from changes in inhibin A or activin A, supporting the concept that inhibin B plays a critical role in mediating the FSH rise in older women.
Journal of Clinical Endocrinology & Metabolism 07/2004; 89(6):2977-81. · 6.50 Impact Factor
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ABSTRACT: To report a gynecologic use of a laparoscopic ultrasound transducer to isolate a myoma for surgical removal.
Case report.
University-based infertility practice.
A 44-year-old woman gravida 1 para 1 with history of a first trimester miscarriage who desired pregnancy as a participant in the donor egg program.
Before she entered the assisted reproduction program, a patient was found to have a myoma that was greater than 2 cm with both intramural and submucosal components. During the laparoscopic evaluation, a laparoscopic ultrasound transducer helped identify and properly locate the myoma in what otherwise appeared to be a normal uterus. Appropriate laparoscopic hysterotomy incision was then made, thereby minimizing uterine trauma.
Appropriately placed hysterotomy incision and successful reconstruction of uterus.
After the successful laparoscopic myomectomy, the patient achieved a pregnancy in our donor oocyte program.
Laparoscopic intraoperative ultrasound can help gynecologic surgeons complete a laparoscopic myomectomy.
Fertility and Sterility 07/2004; 81(6):1671-4. · 3.56 Impact Factor
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ABSTRACT: Specific gravity (SG) may perform as well as creatinine (CR) correction for adjusting urinary hormone concentrations, as well as offer some advantages. We compared the two methods and applied them to US and Bangladeshi specimens to evaluate their use in different populations.
Pearson correlations between serum concentrations and SG, CR, and uncorrected urinary concentrations were compared using paired daily urine and serum specimens from one menstrual cycle from 30 US women. Corrected urinary estrone conjugate and pregnanediol glucuronide concentrations were compared with serum estradiol and progesterone. Urine specimens across one menstrual cycle from 13 Bangladeshi women were used to evaluate the applicability of both methods to a nonindustrialized population. Linear mixed-effects models were used to compare CR and SG values in the Bangladeshi vs US specimens.
There was no significant difference between SG-corrected vs serum and CR-corrected vs serum correlations for either assay. Usable CR results were obtained for all US specimens, but 37% of the Bangladeshi specimens were below the CR assay limit of detection. The Bangladeshi sample had significantly lower CR and higher inter- and intrasubject CR variability than the US sample.
SG is a potentially useful alternative to CR correction for normalizing urinary steroid hormone concentrations, particularly in settings where CR values are highly variable or unusually low.
Clinical Chemistry 06/2004; 50(5):924-32. · 7.91 Impact Factor
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ABSTRACT: Our aim was to develop a statistical method to correct for non-parallelism in an estrone-3-glucuronide (E1G) enzyme immunoassay (EIA). Non-parallelism of serially diluted urine specimens with a calibration curve was demonstrated in an EIA for E1G. A linear mixed-effects analysis of 40 urine specimens was used to model the relationship of E1G concentration with urine volume and derive a statistical correction. The model was validated on an independent sample and applied to 30 menstrual cycles from American women. Specificity, detection limit, parallelism, recovery, correlation with serum estradiol, and imprecision of the assay were determined. Intra-and inter-assay CVs were less than 14% for high- and low-urine controls. Urinary E1G across the menstrual cycle was highly correlated with serum estradiol (r= 0.94). Non-parallelism produced decreasing E1G concentration with increase in urine volume (slope = -0.210, p < 0.0001). At 50% inhibition, the assay had 100% cross-reactivity with E1G and 83% with 17beta-estradiol 3-glucuronide. The dose-response curve of the latter did not parallel that of E1G and is a possible cause of the non-parallelism. The statistical correction adjusting E1G concentration to a standardized urine volume produced parallelism in 24 independent specimens (slope = -0.043+/-0.010), and improved the average CV of E1G concentration across dilutions from 19.5%+/-5.6% before correction to 10.3%+/-5.3% after correction. A statistical method based on linear mixed effects modeling is an expedient approach for correction of non-parallelism, particularly for hormone data that will be analyzed in aggregate.
Journal of Immunoassay and Immunochemistry 02/2004; 25(3):259-78. · 0.69 Impact Factor
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ABSTRACT: The aim of this study was to better characterize the ranges and intercycle variability for day 3 follicle-stimulating hormone, estradiol, and inhibin B levels in normal eumenorrheic women.
Healthy eumenorrheic volunteers were recruited, of whom 27 women were 20 to 25 years old (peak reproductive age) and 36 women were 40 to 45 years old (study population). Blood samples were obtained on day 3 of two consecutive menstrual cycles. In some women, an additional blood sample on day 3 was obtained within 1 year.
In normal women aged 20 to 25 years versus women aged 40 to 45 years, the day 3 follicle-stimulating hormone geometric mean is 5.6 IU/L (95% CI, 3.3-9.5 IU/L) versus 9.6 IU/L (95% CI, 3.8-23.8 IU/L), the day 3 estradiol geometric mean is 44.0 pg/mL (95% CI, 20.4-95.0 pg/mL) versus 52.4 pg/mL (95% CI, 22.4-122.8 pg/mL), and the day 3 inhibin B geometric mean is 100.4 pg/mL (95% CI, 51.7-195.0 pg/mL) versus 52.4 pg/mL (95% CI, 9.5-289.3 pg/mL). Furthermore, 22% of women in the older age group have a normal day 3 follicle-stimulating hormone and estradiol level in one cycle but an elevated value in a consecutive cycle (P=.008).
In women of peak reproductive age, the upper limit of day 3 follicle-stimulating hormone and estradiol levels are 9.5 IU/L and 95.0 pg/mL, respectively, and the lower limit of day 3 inhibin B level is 51.7 pg/mL. If the initial day 3 follicle-stimulating hormone and estradiol levels in an older woman are normal, then a second measurement in a subsequent cycle should be obtained before counseling this woman regarding her reproductive potential.
American Journal of Obstetrics and Gynecology 11/2003; 189(4):1080-4. · 3.47 Impact Factor
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ABSTRACT: To determine the extent of intercycle and interobserver variability in antral follicle (AF) count and their impact on stimulation quality in IVF.
Prospective evaluation of the impact on AF count of GnRH agonist down-regulation and interobserver variability. Retrospective evaluation of intercycle variability in AF count.
University ART clinic.
Twenty subjects were used to evaluate the effect of GnRH agonist down-regulation upon AF count; six of whom were used to evaluate interobserver variability. Fifty patients experiencing two or three cycles of IVF within a 1-year interval.
Transvaginal ultrasound exams before and after down-regulation with a GnRH agonist. Videotaped day-3 transvaginal ultrasound exams.
[1] Intercycle and interobserver variability in antral follicle count. [2] Oocytes retrieved, peak estradiol, gonadotropin dose, duration of stimulation and cancellation rates.
There is moderate intercycle and interobserver variability in AF counts. GnRH agonist down-regulation does not significantly change AF count. In infertility patients undergoing IVF, paired analysis between the low- and high-AF count cycles did not show a difference in quality of stimulation or cycle cancellation rates.
Within an individual patient, higher AF count in a given cycle was not predictive of better stimulation compared with the case of a lower count cycle.
Fertility and Sterility 10/2003; 80(3):577-83. · 3.56 Impact Factor
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Michael R Soules
Fertility and Sterility 09/2003; 80(2):295-9. · 3.56 Impact Factor
