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PubMed2006

Rational diagnosis and treatment in infertility.

Subfertility is a statistical concept. When a pregnancy has not been achieved within a year of unprotected intercourse, the odds are that an underlying pathological mechanism is at play. Advanced female age, longer duration and primary infertility, are important prognostic factors, suggestive of low fecundity and indicating a need for further diagnosis and treatment. Many diagnostic tests only have screening value and the only gold standards are hysteroscopy and laparoscopy. Severely impaired semen quality should lead to andrological work-up. Postcoital test and endometrial biopsy are obsolete. Treatment should preferably be aetiological, such as in anovulation, and sometimes also in endometriosis and tubal infertility. Primary treatment of male infertility is not proven to be advantageous. Conception-enhancing techniques such as intrauterine insemination (IUI), in vitro fertilisation (IVF) with or without intracytoplasmic sperm injection (ICSI), have shown to be effective. As a rule, and where possible, IUI is preferred and only if four to six cycles have failed should IVF be offered.

Anovulation↗
PubMed2005

Estimating live birth rates after ovulation induction in polycystic ovary syndrome: sample size calculations for the pregnancy in polycystic ovary syndrome trial.

Polycystic ovary syndrome (PCOS) affects approximately 5% of the female population, and is a leading cause of infertility, primarily secondary to anovulation. Clomiphene citrate has been standard therapy for ovulation induction in patients seeking pregnancy, but recent evidence suggests that insulin sensitizing agents such as metformin may also be effective. The National Institute of Child Health and Human Development's Reproductive Medicine Network has begun a randomized, double-blind trial of clomiphene vs. metformin vs. clomiphene plus metformin for the induction of ovulation in patients with PCOS seeking pregnancy, with live birth rate as the primary outcome. Because the available literature was largely limited to surrogate outcomes such as ovulation and pregnancy rates, we created a Markov model to derive estimates of likely live birth rates in each arm. Using these estimates, we then constructed an algorithm that allowed only two formal comparisons between the three arms. First, we assumed that combination therapy would have to be superior to the next best single-agent therapy in order to be preferred, because of complexity, costs, increased side effects, etc. If combination therapy is not superior to the next best single agent, then the only other comparison of interest is between the two single agent therapies. Because the third possible comparison, between the best and worst of the three therapies, is not clinically relevant, it can be eliminated from formal statistical consideration, with subsequent reduction in sample size. Based on the opinion of the Network Steering Committee that a 15% absolute difference in live birth rates would be clinically relevant, our methodology resulted in a sample size of 226 per arm, or a total of 678 subjects. The PPCOS trial should definitively answer the question of the relative efficacy of metformin, clomiphene, and combination therapy in the treatment of infertile women with PCOS.

Adolescent↗
PubMed2005

Ovarian size and blood flow in women with polycystic ovary syndrome and their correlations with endocrine parameters.

OBJECTIVE: To determine how common polycystic ovarian morphology may be in women given the clinical diagnosis of polycystic ovary syndrome (PCOS) based on chronic anovulation and hyperandrogenism and whether certain hormonal factors correlate with ovarian morphology and blood flow. DESIGN: Prospective study. SETTING: Two academic endocrinology centers in Italy. PATIENT(S): Three hundred twenty-six women with PCOS and 50 age-matched and weight-matched ovulatory women. INTERVENTION(S): Ultrasound assessment of ovarian morphology in patients and controls and ovarian blood flow and fasting hormone levels in a subset of 50 patients and matched controls. MAIN OUTCOME MEASURE(S): Ovarian morphological assessments, ovarian blood flow by pulsatility index (PI) and resistance index (RI), and measurements of gonadotropins, estrogen, sex hormone-binding globulin, androgens, inhibin B, glucose, and insulin. RESULT(S): Using strict ultrasound criteria, 195 woman (60%) had enlarged ovaries, 135 (35%) had normal ovarian size but characteristic morphology, and 16 (5%) had normal size and morphology. Ovarian blood flow was increased (reduced PI and RI) in PCOS. All hormonal parameters were elevated in PCOS. Ovarian size correlated only with insulin and a measure of insulin resistance. Ovarian blood flow correlated positively with insulin, T, free T, and E2 but not with luteinizing hormone. Inhibin B showed a negative correlation with ovarian blood flow. CONCLUSION(S): When a clinical diagnosis of PCOS was made, virtually all women were found to have characteristic ovarian morphology. Insulin correlated with increased ovarian size as well as with increased blood flow. Blood flow also correlated positively with sex steroids but negatively with inhibin B.

Analysis of Variance↗
PubMed2005

Müllerian-inhibiting substance reflects ovarian findings in women with polycystic ovary syndrome better than does inhibin B.

OBJECTIVE: To investigate Müllerian-inhibiting substance (MIS) levels in women with polycystic ovary syndrome (PCOS), as well as relationships to ovarian morphology, levels of inhibin B, and other reproductive hormones. DESIGN: Prospective clinical study. SETTING: Academic endocrinology centers in Palermo, Italy and New York. PATIENT(S): Forty-six women with PCOS, recruited on the basis of the classic criteria of chronic anovulation and hyperandrogenism, and 25 age-matched ovulatory controls. INTERVENTION(S): Fasting blood was obtained in all subjects in the early follicular phase (days 5-6) after spontaneous or induced menses (in PCOS), and transvaginal ultrasounds were performed. MAIN OUTCOME MEASURE(S): Assessment of values for luteinizing hormone (LH), testosterone (T), androstenedione (A), estradiol (E2), inhibin B, MIS, fasting insulin, and the calculated quantitative sensitivity check index (QUICKI), as well as assessments of ovarian volume and blood flow. RESULT(S): Women with PCOS had higher LH, T, and A; higher insulin and lower QUICKI; and higher ovarian volume and lower pulsatility index. Inhibin B concentrations were statistically significantly higher in PCOS patients (70 +/- 8.0 vs. 40 +/- 3.4 pg/mL), as was MIS (6.7 +/- 0.9 vs. 4.6 +/- 0.5 ng/mL). Inhibin B had a statistically significant direct correlation with levels of MIS (r = 0.351). However, MIS, but not inhibin B, had a statistically significant positive correlation with ovarian size (r = 0.350); the reproductive hormones LH, T, A, and E2; and insulin (r = 0.249), independent of body mass index. Women with PCOS with the highest levels of MIS had higher ovarian volumes and values of LH, T, A, and insulin. CONCLUSION(S): Measurements of MIS reflect ovarian findings in PCOS better than levels of inhibin B and are more frequently elevated. However, MIS lacks sensitivity for use as a diagnostic tool in PCOS.

Anovulation↗
PubMed2006

Addition of human chorionic gonadotropin to clomiphene citrate ovulation induction therapy does not improve pregnancy outcomes and luteal function.

In a randomized prospective study, 125 women with World Health Organization class II anovulation received 50 mg of clomiphene citrate alone (group A, n = 65) or 50 mg of clomiphene citrate plus hCG (group B, n = 60) in a total of 125 cycles during natural intercourse-advised cycles. There were no statistically significant differences between groups regarding pregnancy outcomes and midluteal P levels, but luteal phase length was longer in group A.

Abortion, Spontaneous↗
PubMed2006

Diagnosis, phenotype, and prevalence of polycystic ovary syndrome.

New diagnostic criteria for polycystic ovary syndrome (PCOS) suggested three main phenotypes: classic (hyperandrogenism and anovulation), ovulatory, and normoandrogenic. However, it is unclear whether the normoandrogenic phenotype actually represents PCOS. Overall, 6% to 8% of reproductive-aged women suffer from PCOS, making this disorder one of the most common endocrine abnormalities.

Anovulation↗
PubMed2005

[Use of aromatase inhibitors in infertile women].

Aromatase inhibitors (AI) block the last enzymatic step of estrogen production, the aromatization of the A-cycle of aromatizable androgens and particularly, androstenedione (D4) and testosterone (T). Molecules designed for interfering with aromatase activity have existed for many years. Yet the activity of products of the aminogluthetimide era was too unspecific and these substances carried too many side effects for being used clinically. Today, however, 3rd generation AIs have become available that are highly specific and essentially devoid of side effects. These molecules have recently been approved for treating breast cancer in post-menopausal women, either in advanced forms, or as part of adjuvant therapy. In women whose ovaries are active, a temporary inhibition of E2 production will activate gonadotropins and in turn, stimulate follicular growth. In cancer patients, this property precludes the use of AIs in women whose ovaries are still active, unless gonadotropins are blocked. In infertile patients, this property of AIs has been put to play for inducing ovulation. AIs have been used both in women who do not ovulate but whose hypothalamo-pituitary-gonadal (HPG) axis is active (oligo-anovulators of PCOD type) and in those who ovulate regularly but in whom multiple ovulation is sought for treating infertility or as part of IVF. Like CC, AIs are not usable in women whose gonadotropins are suppressed, as in the case of hypothalamic amenorrhea. The sum of data available on the use of AI for inducing ovulation remains however meager to this date and is mainly constituted of pilot and non-randomized trials. Yet mounting evidence tends to support AIs' advantages over CC for induction of ovulation. Hence, we think that these drugs will play a key role for the induction of ovulation in the future.

Anovulation↗
PubMed2006

Ovulation induction by antiestrogens in an Indian tropical vespertillionid bat, Scotophilus heathi.

The ovulation induction property of ICI 182,780 a pure antiestrogen and enclomiphene citrate (ENC) was carried out in Scotophilus heathi, an Indian tropical vespertillionid bat, during December to February i.e., preovulatory period. This bat ovulates two ova naturally and shows ovulatory asynchrony. The study showed that 100 ìg of ENC followed by 10 IU hCG resulted in significantly lower number of ovulation. Whereas, the pure antiestrogen ICI 182,780 at a dose of 100 ìg followed by 10 IU hCG resulted in ovulation induction (4.2 +/- 0.4), which is significantly different in comparison to other groups. This is possibly the first report of ovulation induction using this pure antiestrogen i.e., ICI 182,780 in any bat as well as in any animal model that exhibits temporary anovulation similar to polycystic ovary disease (PCOD). This antiestrogen may be useful to induce ovulation in PCOD patients.

Animals↗
PubMed2006

What role of estrogens in ovarian stimulation.

Estrogens and progesterone represent the key ovarian hormones produced by the developing ovulatory follicle. Serum concentrations start to rise from the mid-follicular phase onwards, coinciding with the development of the dominant follicle. Androgens are converted into estrogens by aromatase activity of the granulosa cells and secreted into the follicular fluid compartment. Their significance for oocyte maturation and fertilizing potential remains unknown. Paradoxically, serum estrogen levels are within the normal range in the majority of patients presenting with cycle abnormalities due to ovarian dysfunction. Similarly, the distribution of estradiol (E2) and follicle-stimulating hormone (FSH) levels within the normal range is comparable between normo-ovulatory controls and normogonadotropic anovulatory women. Moreover, E2 levels are only moderately correlated with luteïnizing hormone (LH), testosterone (T), androstenedione (A), sex hormone binding globulin (SHBG), the free androgen index (FAI) and finally ovarian volume as measured by ultrasound. No correlations could be found between E2 and age, body weight and cycle history and FSH. Androgen concentrations and cycle history--but not E2--were the most prominent predictors of ovarian response tot the conventional ovulation induction. Anti-estrogenic compounds like clomiphene citrate and tamoxifen have remained the first-line treatment of choice for anovulation. Certainly, CC and to a lesser extent tamoxifen have demonstrated to exhibit undesired anti-estrogenic properties at the uterine level however. However, large follow-up studies demonstrate cumulative ovulation rates around 75%, and the overall pregnancy rates of around 50%. Aromatase inhibitors, another way to interfere with estrogen feedback, represent a feasible option. This claim should, however, be substantiated by further sufficiently powered, controlled studies, and the possibility of embryo toxicity remains a major concern. In retrospect, CC and tamoxifen represent the first generation of selective estrogen receptor modulators (SERMs), and many new compounds have recently been introduced into the clinic or are currently under investigation. The major focuses of these compounds are bone density, the cardiovascular system and breast cancer. No studies have been reported in the area of ovarian stimulation.

Anovulation↗
PubMed2005

Length of progesterone exposure needed to resolve large follicle anovular condition in dairy cows.

Hypothalamic unresponsiveness to an estradiol surge appears to be an underlying cause of large follicle anovular condition (follicular cysts), but progesterone exposure for 7 days resolves this condition. In this study, dairy cows with induced (Experiment 1) or naturally occurring (Experiment 2) follicular cysts were treated for different times with progesterone. In Experiment 1, 16 of 26 cows (62%) were induced into anovulation by causing a GnRH/LH surge when no ovulatory follicle was on the ovary. Anovular cows (n = 16) were assigned to one of four treatment groups ( 0, 1, 3, or 7 days of progesterone treatment) using an intravaginal, progesterone-releasing implant (CIDR). All anovular cows had low circulating progesterone concentrations before controlled internal drug releasing (CIDR) and greater concentrations that reached steady state (1.3 +/- 0.1 ng/mL progesterone) by 3 h after CIDR insertion. Circulating progesterone decreased to basal concentrations by 4 h after CIDR removal. Cows were treated with 5mg estradiol benzoate (EB) 12 h after CIDR removal. None (n = 4) of the control cows (0 day) had an LH surge after EB. All of the 3 days (5/5) and 7 days (4/4) CIDR-treated cows had an LH surge following EB, but only one of the 1 day (1/3) CIDR-treated cows. Magnitude of the LH peak was similar in the 3 and 7 days cows. All cows treated for 7 days ovulated (4/4), whereas, ovulation occurred in only 3/5, 1/3, and 0/4 of the cows treated for 3, 1, and 0 day, respectively. The two cows in the 3 days group that did not ovulate had a normal LH surge, but these two cows had a smaller maximal follicle size than cows that ovulated. In Experiment 2, naturally anovular lactating dairy cows (24 of 248) were identified using weekly ultrasonography. All anovular cows grew follicles to >12 mm, with 54% (13 of 24) having follicles larger than ovular size (15-24 mm) and 33% (8 of 24) having follicles that would be considered cystic (>25 mm). Anovular cows were randomly assigned to CIDR treatment for 0, 1, or 3 days. All (7/7) of 3 days, 33% (3/9) of 1 day, and 25% (2/8) of control (0 day) cows ovulated by 1 week after CIDR removal. Thus, 3 days but not 1 day of progesterone exposure appears to be sufficient to reinitiate estradiol responsiveness of the hypothalamus.

Administration, Intravaginal↗
PubMed2003

Plasma TBARS, blood GSH concentrations, and erythrocyte antioxidant enzyme activities in regularly menstruating women with ovulatory and anovulatory menstrual cycles.

BACKGROUND: Vigorous physical activity and subsequent depressed ovarian hormone secretion resulting in anovulatory menstrual cycles can affect erythrocyte antioxidant system in premenopausal women and contribute to attenuated protection against oxidative stress. METHODS: A total of 17 regularly menstruating women participated in the study. Prospective subjects monitored their basal body temperature (BBT) for 3 months prior to the study. Plasma progesterone concentration was assayed between the 7th and 9th day and again between the 22nd and 25th day of the menstrual cycle and made possible the classification of participants as either ovulating or non-ovulating. Plasma 17-beta-estradiol concentration was determined on the same menstrual cycle days as progesterone. Plasma thiobarbituric acid-reacting substances (TBARS) served as an index of plasma lipid peroxidation. Whole blood-reduced glutathione (GSH) concentration and glutathione peroxidase (GSH-PX) activity and erythrocyte catalase (CAT), superoxide dismutase and glutathione reductase (GSH-RX) represented red cells antioxidants. RESULTS: In non-ovulating women, the lack of progesterone peak between the 22nd and 25th day of the menstrual cycle was demonstrated. In addition, markedly lower (P<0.008) plasma 17-beta-estradiol concentrations in non-ovulating females than in ovulating ones in the follicular phase was noted. In the luteal phase, plasma 17-beta-estradiol levels in non-ovulating subjects tended to be lower (P<0.06) than in ovulating counterparts. Mean concentrations of plasma thiobarbituric-reacting substances and blood-reduced glutathione and mean activities of glutathione reductase, glutathione peroxidase and catalase did not differ significantly in ovulating and non-ovulating women. In non-ovulating women, both between the 7th and 9th day and the 22nd and 25th day of the menstrual cycle, erythrocyte superoxide dismutase (SOD) activity was higher (P<0.02) than in their ovulating counterparts. In ovulating subjects, significant and inverse correlation was demonstrated between circulating estradiol and SOD activity in collected data from both follicular and luteal phases. CONCLUSIONS: Current results indicate that persistent ovarian hormone disturbances in regularly menstruating women, and resultant anovulation did not affect plasma lipid peroxidation and GSH-dependent erythrocyte antioxidant defense. However, lower plasma estradiol concentrations resulted in attenuated erythrocyte SOD inhibition and elevated enzyme activity. The mechanism of inhibitory estradiol action on erythrocyte SOD activity as well as the importance of this effect for antioxidant protection merits further studies.

Adult↗
PubMed1977

The use of clomiphene citrate.

Two hundred and fifty-five women received clomiphene citrate during a 10-year period. Fifty-six were treated diagnostically and one hundred and ninty-nine therapeutically for infertility. It is concluded that clomiphene may aid in confirming the diagnosis and establishing a prognosis in patients with primary or secondary amenorrhea. The success of clomiphene therapy in patients with anovulatory infertility is related to the etiologic factor responsible for the anovulation, but results can be improved by adjustment of the therapeutic regimen used. In the present series, 48% of the patients who ovulated became pregnant, and 25.3% of the pregnancies were miscarried. Those patients who ovulated spontaneously and became pregnant after having discontinued clomiphene therapy showed only a 10% abortion rate. A review of the results indicates that both the ovulation rate and the pregnancy rate can be improved if adjustments are made in therapy to ensure normal follicular maturation and corpus luteum function.

Abortion, Spontaneous↗
PubMed1979

Relationship of weight to successful induction of ovulation with clomiphene citrate.

Over a 6 1/2-year period, 117 patients who were anovulatory, euthyroid, and estrogen-primed were treated with clomiphene citrate. Graduated doses from 50 mg to 250 mg daily for 5 days were used to induce ovulation. Of 62 patients who completed treatment, 50 ovulated and 12 did not. Several factors, including age, duration of infertility, weight, previous menstrual history, previous pregnancy history, and previous use of oral contraceptives, were investigated to determine conditions which might influence response. Only weight was found to be significantly different between responders and nonresponders. Furthermore, there was a linear relationship between body weight and dose of clomiphene required to induce ovulation. The ovulation rate for those completing therapy was 81% with a pregnancy rate of 76% of the total and 94% of those ovulating. Population homogeneity with anovulation as the major cause of infertility appears to be the most plausible explanation for the high pregnancy rate.

Adult↗
PubMed1980

Infertility: a review of 291 infertile couples over eight years.

Two hundred and ninety-one infertile couples were studied over an 8-year period. Anovulation was the most common cause of infertility, being the causative factor in half of the patients. Ovulation induction with clomiphene or cyclic hormone therapy readily achieved pregnancy in the majority of these patients. The distribution of other etiologic factors was fairly uniform, but treatment was much less successful. Thorough evaluation of both partners is advised both for treatment purposes and as a more accurate guide to the prognosis for conception. Furthermore, even in the presence of oligospermia, ovulation induction may be successful in achieving a pregnancy.

Anovulation↗
PubMed1981

The use of gonadotropins for induction of ovulation.

There has been impressive progress in the treatment of anovulation with gonadotropins in the last two decades. At the present time most patients can be helped. The treatment is expensive and complicated. To obtain good results with the fewest complications, patients should be closely monitored by measuring urinary or plasma estrogen levels, and treatment should be given only in centers where the estrogen assay is readily available. Severe hyperstimulation is avoidable, but the high rate of multiple gestations remains unavoidable. Possibly with sonographic monitoring of follicular development this problem will be solved.

Adult↗
PubMed1981

Fertility following bilateral ovarian wedge resection: a critical analysis of 90 consecutive cases of the polycystic ovary syndrome.

Fertility following bilateral ovarian wedge resection (BOWR) was evaluated in a retrospective cohort study of 90 consecutive cases of the polycystic ovary syndrome. Post-BOWR follow-up was available for varying time spans of up to 10 years. BOWR resulted in the resumption of menstrual cyclicity in 91.1% (82/90) of the cases. However, within this ovulatory group, 26 patients were characterized by oligo-ovulation and a significantly reduced conception rate (29.2%), as compared with that of 56 normo-ovulatory counterparts (60.3%). Although the crude overall conception rate for this series was 47.8%, the overall cumulative probability of conception at the end of follow-up as determined by life table analysis was 73%. The likelihood of conception at any given point in time was estimated by a monthly fecundability rate of 1.34%. Our findings also indicate that the probability of post-BOWR conception was unaffected by age, race, ward status, or duration of infertility. In contrast, persistent post-BOWR oligo- or anovulation and the presence of concurrent tuboperitoneal disease were reaffirmed as the most important determinants of the likelihood of post-BOWR conception. A minimum incidence of 7.8% was documented for acquired post-BOWR pelvic disease.

Adolescent↗
PubMed1982

Conservative surgery versus expectant management for the infertile patient with mild endometriosis.

During an 8-year period, the records of 90 patients with mild pelvic endometriosis diagnosed by endoscopy were reviewed to determine whether conservative surgical treatment resulted in higher pregnancy rates than expectant management. Forty-five patients were found to have mild endometriosis as the only abnormality in a complete fertility workup. Sixteen patients were managed expectantly, and 75% became pregnant in 1 year. Twenty-nine patients had conservative surgery, and 72.4% conceived in 1 year. This surgery-to-pregnancy interval was similar in both groups. Sixty patients had mild endometriosis only or mild endometriosis and anovulation corrected by clomiphene citrate. The pregnancy rate in 1 year was 72.2% in 18 patients managed expectantly and 76.2% in 42 patients treated with conservative surgery. The surgery-to-pregnancy interval was 5 and 6 months, respectively. These results suggest that expectant management should be considered prior to medical or surgical treatment of infertile patients with mild endometriosis.

Adult↗
PubMed1982

Exaggerated prolactin response of thyrotropin-releasing hormone in women with anovulatory cycles: possible role of endogenous estrogens and effect of bromocriptine.

Twenty-one women 18 to 36 years old, presenting with chronic anovulation, were compared with 10 normally cycling women. The patients were characterized by low progesterone (P) levels (0.93 +/- 0.14 ng/ml versus 15.5 +/- 1.4 in controls), whereas 17 beta-estradiol (E2) was moderately decreased (110.2 +/- 8.3 pg/ml versus 162.8 +/- 14.5 in controls) realizing a relative hyperestrogenism. Basal prolactin (PRL) levels were not elevated (12.1 +/- 0.97 ng/ml versus 9.2 +/- 0.7 in controls), but after thyrotropin-releasing hormone (TRH) stimulation an exaggerated response was observed (114.5 +/- 7 ng/ml versus 55.8 +/- 9 in controls). Patients were treated with bromocriptine (1.25 mg 2 times a day) for 3 months. Fifteen responded with ovulatory cycles, and five became pregnant. Progesterone increased significantly (10.2 +/- 1.3 ng/ml), whereas in patients who did not ovulate P increased only slightly (1.56 +/- 0.18 ng/ml). The particular endocrine profile of these patients (P/E2 imbalance) realizing relative hyperestrogenism may be responsible for the exaggerated PRL response to TRH. Bromocriptine, in reducing this transient, or masked, hyperprolactinemia, allows in many patients the return to ovulatory cycles. This mechanism may be one of the possible pathways leading to chronic functional or organic hyperprolactinemia.

Adolescent↗