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PubMed2002

Should patients with polycystic ovarian syndrome be treated with metformin?

The recognition of insulin resistance as a principal factor in the pathogenesis of polycystic ovarian syndrome (PCOS) has led to the use of insulin-lowering agents, also called 'insulin-sensitizing drugs', for its treatment. The most extensively studied insulin-lowering agent in the treatment of PCOS is metformin: an oral antihyperglycaemic agent used initially in the treatment of type 2 diabetes mellitus. Metformin is effective in the treatment of PCOS-related anovulation and infertility. Moreover, preliminary evidence indicates that metformin may also be effective in decreasing the risk of early spontaneous miscarriage in women with PCOS. Metformin also appears to induce cardioprotective effects on serum lipids as well as plasminogen activator inhibitor (PAI)-1 and may decrease the risk of development of type 2 diabetes. The highly promising therapeutic profile of metformin is related to the role of this agent in controlling an important aetiologic factor in the pathogenesis of PCOS: hyperinsulinaemia.

Abortion, Spontaneous↗
PubMed2003

Pseudo-isolated FSH deficiency caused by an inhibin B-secreting granulosa cell tumour: case report.

Isolated FSH deficiency due to a mutation in the FSHbeta subunit is characterized by an extremely low serum FSH concentration. We report a patient who presented with an FSH of 0.8 mIU/ml and infertility associated with anovulation. Endocrinological assessment and immunohistochemistry revealed that a granulosa cell tumour was secreting inhibin B and suppressing FSH; however, LH and estradiol were within their normal ranges. Upon removal of the tumour, inhibin B decreased and FSH levels rose to normal values. The patient subsequently conceived and delivered successfully. Based on this case and on those previously described in the literature, we suggest that inhibin B levels should be evaluated in anovulatory patients having a clinical presentation consistent with functional hypothalamic amenorrhoea and very low to normal values of FSH.

Adult↗
PubMed2004

In vitro maturation and fertilization of oocytes from an intact ovary of a surgically treated patient with endometrial carcinoma: case report.

Polycystic ovary syndrome (PCOS) with prolonged anovulation had resulted in endometrial carcinoma in a 43-year-old woman. Since she and her husband did not share common biological children, they requested fertility preservation. Due to the woman's age, high dose progesterone and postponing surgery were both considered inappropriate. We therefore proposed oocyte retrieval from the ovaries removed by staging laparotomy followed by in vitro maturation and ICSI. Surrogacy could then enable a future pregnancy. Fourteen of 17 (82%) retrieved oocytes matured in vitro. Following ICSI, eight embryos (two at the pronuclear stage and six cleaved) were cryopreserved. To the best of our knowledge, this is the first report of oocyte aspiration, maturation and fertilization from an ovary removed by laparotomy.

Adult↗
PubMed2004

An economic comparison of a laparoscopic electrocautery strategy and ovulation induction with recombinant FSH in women with clomiphene citrate-resistant polycystic ovary syndrome.

BACKGROUND: Recombinant FSH (rFSH) is the current standard treatment for ovulation induction in women with polycystic ovary syndrome (PCOS) that do not respond to clomiphene citrate. Ovulation induction with rFSH is known to be costly due to the necessity of daily injections and intensive monitoring. An alternative strategy, starting with electrocautery of the ovaries, may be a less costly option. METHODS: An economic evaluation was set up alongside a multicentre randomized clinical trial comparing laparoscopic electrocautery of the ovaries, followed by clomiphene citrate and rFSH when anovulation persisted, and treatment with rFSH in 168 women with clomiphene citrate-resistant PCOS. Data on resources used for treatment and productivity loss were collected prospectively up to an eventual ongoing pregnancy with a time horizon of 12 months. RESULTS: At 12 months the ongoing pregnancy rates were 67% for both the electrocautery strategy and rFSH treatment. Mean total costs per woman were 5308 euros for the electrocautery strategy and 5925 euros for treatment with rFSH, resulting in a mean difference of 617 (95% CI: -382 euros to 1614 euros). CONCLUSIONS: The total treatment costs up to an ongoing pregnancy are comparable for rFSH treatment and an alternative strategy starting with electrocautery. Due to a lower number of multiple pregnancies, the electrocautery strategy can be expected to result in lower total costs when costs of the delivery are included.

Adult↗
PubMed2004

Laparoscopic electrocautery of the ovaries versus recombinant FSH in clomiphene citrate-resistant polycystic ovary syndrome. Impact on women's health-related quality of life.

BACKGROUND: Ovulation induction with gonadotrophins is the standard treatment strategy for women with clomiphene citrate (CC)-resistant polycystic ovary syndrome (PCOS). Laparoscopic electrocautery of the ovaries is an alternative treatment modality, leading to a comparable cumulative pregnancy rate. In deciding which treatment to opt for, women's health-related quality of life (HRQoL) should be taken into account. METHODS: A total of 168 CC-resistant women with PCOS were randomly assigned to receive either the electrocautery strategy, entailing laparoscopic electrocautery of the ovaries followed by CC and recombinant FSH (rFSH) if anovulation persisted, or ovulation induction with rFSH. We assessed women's HRQoL with the standard questionnaires Short Form-36, Rotterdam Symptom Checklist and Center for Epidemiological Studies Depression Scale, administered before randomization and 2, 12 and 24 weeks thereafter. RESULTS: The intention to treat analysis revealed no significant differences between the treatment groups on any of the scales at any point during follow-up. In women without an ongoing pregnancy, those treated with rFSH showed significantly more depressive symptoms than women allocated to the electrocautery strategy, with or without CC, although differences were small. CONCLUSIONS: Overall, HRQoL was not affected in both groups. In women still under treatment, rFSH was slightly more burdensome for women's HRQoL than electrocautery with or without CC.

Clomiphene↗
PubMed2006

Cost-effectiveness of aromatase inhibitor co-treatment for controlled ovarian stimulation.

BACKGROUND: To compare the clinical results and the cost-effectiveness of using the aromatase inhibitor, letrozole, in conjunction with FSH and FSH alone for controlled ovarian stimulation (COS) in patients undergoing intrauterine insemination (IUI) for a variety of indications. METHODS: Four hundred and thirty-two consecutive patients who underwent 872 IUI cycles were included. The study population was composed of two groups. Group I included 308 patients who underwent 589 IUI cycles with letrozole and FSH for the following indications: anovulation (143 cycles), male factor infertility (147 cycles), unexplained infertility (250 cycles), endometriosis (18 cycles) and combined indications (31 cycles). Group II included 124 patients who underwent 283 IUI cycles who received FSH only for the following indications: ovarian factor infertility (82 cycles), male factor infertility (66 cycles), unexplained infertility (114 cycles), endometriosis (13 cycles) and other indications (8 cycles). Main outcome measures included number of mature follicles >16 mm in diameter, dose of FSH used per cycle, clinical pregnancy rate and cost-effectiveness ratio per pregnancy. RESULTS: FSH dose required for ovarian stimulation was significantly lower when letrozole was used (P < 0.0001). Although a significantly higher number of follicles >16 mm and endometrial thickness at the day of hCG administration (P < 0.0001) were observed in Group II, pregnancy rate per started (14.4 versus 15.9%) and per completed cycles (15.77 versus 18.07%) was the same in Group I and Group II, respectively. IUI cancellation rate was significantly lower with letrozole treatment (P = 0.05%). The cost per cycle was significantly lower in Group I versus Group II (468.93 Can dollars +/- 418.18 versus 1067.28 +/- 921.43; P < 0.0001). The cost-effectiveness ratio was 3249.42 dollars in the letrozole group and 6712.00 dollars in the FSH-only group. CONCLUSION: A letrozole-FSH combination could be an effective ovarian stimulation protocol in IUI cycles. Such a protocol may be more cost-effective than FSH alone because of the difference of FSH dose and cost. A randomized controlled trial is needed to further substantiate this finding.

Aromatase Inhibitors↗
PubMed2006

The preconceptual contraception paradigm: obesity and infertility.

Obesity is a major health problem across the world. Recent editorials suggest that obese patients should be denied treatment of any kind aimed to improve ovulation rates and achieve pregnancy until they have reduced their BMI. We propose that this approach is not a resolution of the problem, but indeed may amplify the maternal and perinatal complications attributed to fertility centres. Obesity independent of polycystic ovary syndrome (PCOS) is associated with anovulation, and minimal weight loss alone is an effective therapy for induction of ovulation in both obese women and obese PCOS women. Consequently, lifestyle programmes encouraging weight loss should be considered to be an ovulation induction therapy and due consideration for a potential pregnancy in an obese woman given. We propose that women with a BMI in excess of 35 kg m(2) should lose weight prior to conception-not prior to receiving infertility treatment. Therefore, clinicians undertaking the management of infertility in obese women should adopt measures to reduce their body mass prior to exposing them to the risks of pregnancy. We advocate that this approach should be aggressively managed including pharmacological strategies; intrinsic in this programme is the use of contraception and high-dose folic acid during that period of preconceptual weight reduction.

Body Mass Index↗
PubMedDate not supplied

Obesity and reproductive disorders in women.

Obesity, particularly the abdominal phenotype, is associated with several reproductive disturbances. Whereas mechanisms by which obesity affect fertility are complex and still not completely understood, an important role appears to be played by the presence of a condition of functional hyperandrogenism and hyperinsulinaemia, which accompanies the insulin-resistant state. In women with the polycystic ovary syndrome, abdominal obesity may be co-responsible for the development of hyperandrogenism and associated chronic anovulation, through mechanisms primarily involving the insulin-mediated overstimulation of ovarian steroidogenesis and decreased sex hormone-binding globulin blood concentrations. By these mechanisms, obesity may also favour resistance to clomiphene and gonadotrophin-induced ovulation and reduce outcomes of IVF/ICSI procedures. Due to the beneficial effects of weight loss, lifestyle intervention programmes should represent the first-line approach in the treatment of infertile obese women. Insulin-sensitizing agents may add further benefits, particularly if administered in combination with hypocaloric dieting. Therefore, individualized pharmacological support aimed at favouring weight loss and improving insulin resistance should be widely extended in clinical practice in obese infertile patients. This may be beneficial even during pregnancy, thereby permitting favourable physiological delivery and healthy babies.

Female↗
PubMedDate not supplied

Progestogens for endometriosis: forward to the past.

We performed a MEDLINE and EMBASE search to identify all studies published in the last decade in the English language literature on the use of progestogens for the treatment of endometriosis. Our aim was to clarify the biological rationale for treatment and define the drugs that can be used with their doses, routes of administration, efficacy and tolerability. Progestogens may prevent implantation and growth of regurgitated endometrium inhibiting expression of matrix metalloproteinases and angiogenesis, and they have several anti-inflammatory in-vitro and in-vivo effects that may reduce the inflammatory state generated by the metabolic activity of the ectopic endometrium, and the consequent immune response. Oral contraceptives increase the abnormally low apoptotic activity of the endometrium of women with endometriosis. Moreover, anovulation, decidualization, amenorrhoea and the establishment of a steady estrogen-progestogen milieu contribute to disease quiescence. Progestogens are effective in the control of pain symptoms in approximately three out of four women with endometriosis. Their effect does not seem to be inferior to that of other drugs used for the disease. Different compounds can be administered by the oral, intramuscular, subcutaneous, intravaginal or intrauterine route, each with specific advantages or disadvantages. Medical treatment plays a role in the therapeutic strategy when administered over a prolonged period of time. Given their good tolerability, minor metabolic effects and low cost, progestogens must therefore be considered drugs of choice and are currently the only safe and economic alternative to surgery. However, their contraceptive effectiveness limits their use to women who do not wish to have children in the short term.

Endometriosis↗
PubMedDate not supplied

The follicular excess in polycystic ovaries, due to intra-ovarian hyperandrogenism, may be the main culprit for the follicular arrest.

This review exposes the follicular abnormalities responsible for anovulation in polycystic ovary syndrome (PCOS). The putative pathophysiological explanations involve the principal intra- and extra-ovarian regulators which intervene during normal folliculogenesis to control the initial recruitment and growth and then the cyclic recruitment. We propose the hypothesis that the follicular problem in PCOS is 2-fold, but with the two abnormalities being linked. First, the intra-ovarian hyperandrogenism may promote early follicular growth, leading to a 2-5 mm follicle excess. Second, the ensuing excessive number of selectable follicles would inhibit the selection process, presumably through follicle-follicle interaction involving granulosa cell (GC) products such as the anti-Müllerian hormone (AMH). These factors would induce a reversible refractoriness to the FSH-induced differentiation of GC. This explanation challenges but does not exclude other hypotheses about the follicular arrest, such as the premature LH action on the GC of selectable follicles. Hyperinsulinism or insulin resistance would act as a second hit, worsening the follicular arrest either through amplification of the intra-ovarian hyperandrogenism or through dysregulation of the GC. The loss of cyclic rhythm would prevent the inter-cycle elevation of FSH, thus perpetuating the impairment of the ovulation process.

Androgens↗
PubMed2005

Using infertile patients in epidemiologic studies on subfecundity and embryonal loss.

Subfecundity is a frequent and serious problem that may sometimes be preventable, but we need to know more about its determinants. Different epidemiologic designs are available. The best of these use prospectively collected data from the population, but they are time consuming, expensive and often hampered by low-participation rates. Most patients undergoing infertility treatment are closely monitored for clinical reasons, making it feasible to use secondary data to study the period from conception to implantation and pregnancy. In spite that infertility patients are highly selected, there are specific exposure-effect relations that can be studied in cohorts of infertility patients. These patients offer a potentially useful setting for studying exposures that operate late in fertilization, whereas the designs may be inadequate to identify exposures that cause reduced sperm counts, anovulation and total occlusion. The clinical sampling and the treatment set limitations for what can be studied. In certain situations, infertile patients can, however, provide useful epidemiologic evidence for learning about the causes of subfecundity.

Abortion, Spontaneous↗
PubMed1996

Naloxone administration does not relieve the inhibition of gonadotropin release in food-restricted, lactating rats.

Lactational anovulation is an important factor in determining birth spacing in women living in developing countries. Therefore, a more comprehensive understanding of the mechanisms involved in the relationships among lactation, nutrition and ovulation is important. This study was designed using the food-restricted, lactating rat to examine whether endogenous opioids might be involved in depressing gonadotropin release. Females were mated after 65 d of age and, beginning on d 42 of life, offered food in unrestricted amounts (control) or were food restricted to 50% of what the controls consumed. On d 15 of lactation, dams were injected with either naloxone hydrochloride (3 mg/kg body weight) or saline and killed 0, 15, 30 or 60 min later. Plasma was analyzed for luteinizing hormone, follicle-stimulating hormone and prolactin. Food restriction decreased plasma concentrations of luteinizing hormone and follicle-stimulating hormone (P < 0.005). Naloxone administration marginally influenced follicle stimulating hormone (P < 0.1), but not luteinizing hormone concentration regardless of diet group. The interaction among diet group, drug group and time of killing was significant for plasma prolactin concentration (P < 0.05). Food restriction lowered prolactin concentrations, but this effect was diminished with increasing time after injection of naloxone. Furthermore, the magnitude of the effect of food restriction was lessened and even reversed with treatment of naloxone. These results indicate that endogenous opioids are not the primary mechanism suppressing luteinizing hormone release in food-restricted lactating rats.

Animals↗
PubMed1996

Molecular biology and biochemistry of human recombinant follicle stimulating hormone (Puregon).

Follicle stimulating hormone (FSH) is a heterodimeric glycoprotein hormone produced in the anterior pituitary gland. The hormone is essential in the regulation of reproductive processes, such as follicular development and ovulation. It is clinically used for treatment of anovulation and in assisted reproduction technologies such as in-vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). Until recently, the only source for human FSH has been the urine from post-menopausal women. Such a natural source implies limited availability and potential product variability. Thus, we have cloned the genes encoding the alpha- and beta-subunits of human FSH and transfected these into Chinese hamster ovary (CHO) cells. A CHO-clone was isolated capable of secreting intact glycosylated FSH with identical amino acid sequences to natural FSH. This cell line was grown in perfusion culture and enabled us to isolate highly pure FSH (> 99%). The complexity of the charge distribution of human recombinant FSH was demonstrated by Isoelectric focusing. The observed microheterogeneity is caused by the large number of carbohydrate chain structures which are added to the four potential glycosylation sites in the alpha beta-dimer. Furthermore, the carbohydrates show a variation in their degree of sialylation which reflects the different pl values of the individual isohormones. Despite the complexity of post-translational modification, the isoform distribution of recombinant FSH produced in a CHO-cell line and grown in perfusion culture is surprisingly similar to that observed with pituitary FSH and urinary FSH. In conclusion, we have shown that FSH-gene transfected CHO-cells are capable of stable serum-free production of recombinant FSH. A process has been developed which assures the consistent and reproducible production of highly-purified recombinant FSH.

Animals↗
PubMed2000

Distribution of steroidogenic enzymes involved in androgen synthesis in polycystic ovaries: an immunohistochemical study.

To find an explanation for the possible working mechanism of laparoscopic ovarian electrocautery for the treatment of anovulation in polycystic ovarian syndrome (PCOS), we evaluated the distribution of steroidogenic enzymes involved in the synthesis of ovarian androgens in surgical pathology specimens of entire polycystic ovaries. A total of 13 formalin-fixed and paraffin-embedded samples of the ovaries of patients with clinically proven PCOS were immunostained with specific antibodies against cholesterol side-chain-cleavage enzyme (P450scc), 3beta-hydroxysteroid dehydrogenase (3beta-HSD), 17alpha-hydroxylase (P450c17) and adrenal 4-binding protein (Ad4BP), a transcription factor of steroidogenic enzymes. Follicular theca cells of all ovaries demonstrated marked immunoreactivity for Ad4BP, P450scc, 3beta-HSD and P450c17. Granulosa cells of seven ovaries expressed Ad4BP, while granulosa cells of three ovaries also showed P450scc. In the granulosa cells of all ovaries, 3beta-HSD and P450c17 immunoreactivity was not observed. In the stroma, luteinized cells of most ovaries demonstrated Ad4BP, P450scc, 3beta-HSD and P450c17 immunoreactivity, but at a much lower level compared with the follicular theca cells. Non-luteinized stromal cells sporadically demonstrated Ad4BP, P450scc, 3beta-HSD and P450c17 immunoreactivity. The stromal steroidogenic cells were mainly located in the ovarian cortex, except for some hilus steroidogenic cells. These data demonstrate that in polycystic ovaries, androgens are mainly produced in the follicular theca cells and to some extent in luteinized stromal cells. This suggests that the working mechanism of laparoscopic electrocautery of the ovary is primarily explained through the reduction of ovarian hyperandrogenism by coagulation of follicular theca cells and concomitant stroma.

3-Hydroxysteroid Dehydrogenases↗
PubMed1999

Caffeine consumption and menstrual function.

The relation between caffeine intake and menstrual function was examined in 403 healthy premenopausal women who belonged to Kaiser Permanente Medical Care Program in 1990-1991. A telephone interview collected information about caffeinated beverage intake as well as other lifestyle, demographic, occupational, and environmental factors. Subjects collected daily urine samples and completed a daily diary for an average of five menstrual cycles. Metabolites of estrogen and progesterone were measured in the urine, each cycle was characterized as anovulatory or ovulatory, and a probable day of ovulation was selected when appropriate. Logistic regression and repeated measures analyses were performed on menstrual parameters. Women whose caffeine consumption was heavy (>300 mg of caffeine per day) had less than a third of the risk for long menses (> or =8 days) compared with women who did not consume caffeine (adjusted odds ratio = 0.30, 95% confidence interval 0.14-0.66). Those whose caffeine consumption was heavy also had a doubled risk for short cycle length (< or =24 days) (adjusted odds ratio = 2.00, 95% confidence interval 0.98-4.06); this association was also evident in those whose caffeine consumption was heavy who did not smoke (adjusted odds ratio = 2.11, 95% confidence interval 1.03-4.33). Caffeine intake was not strongly related to an increased risk for anovulation, short luteal phase (< or =10 days), long follicular phase (> or =24 days), long cycle (> or =36 days), or measures of within-woman cycle variability.

Adult↗
PubMed1990

Infertility and breast cancer: a population-based case-control study.

To investigate whether a history of infertility affects a woman's risk of developing breast cancer, the authors analyzed case-control data collected between 1980 and 1982 as part of the Cancer and Steroid Hormone Study. The 4,730 cases were women aged 20-54 years with a first diagnosis of breast cancer ascertained from eight population-based cancer registries; the 4,688 controls were women randomly selected from the general population of these same eight areas. After controlling for age, age at first birth, and parity, the odds ratio (OR) for breast cancer associated with infertility was 1.01 (95% confidence interval (CI) 0.89-1.15) among gravid women. Controlling for age, the odds ratio was 0.82 (95% CI 0.59-1.14) among nulligravid women. Women who reported that the reason for their infertility was a problem with their ovaries had a risk similar to that for women without a history of infertility (OR = 0.75, 95% CI 0.48-1.24). Women whose physicians reported that the reason for their infertility was anovulation or Stein-Leventhal syndrome also had risks similar to those for women without a history of infertility (OR = 1.26 (95% CI 0.67-2.34) and OR = 1.13 (95% CI 0.46-2.78), respectively). Menopausal status, age at menarche, history of spontaneous abortions, drinking or smoking behavior, use of exogenous hormones, or family history of breast cancer did not appreciably alter the observed odds ratios. If infertility has an effect on breast cancer that is independent of age at first birth, then the effect is small.

Adult↗
PubMed1993

Long acting methods of contraception.

Long acting methods of contraception have been developed and refined over the last 10 years. From the classical long acting progestogen-only depot preparations we now have a range of delivery systems including both combined and progestogen only injection systems and vaginal rings also containing either progestogen only or oestrogen and progestogen in combination. Subcutaneous implants at present containing only a progestogen, offer a range of durations from 2-5 years. The efficacy of these methods is high, with failure rates as low as 0.1 per 100 woman years. However, with progestogen only systems a significant proportion of women develop unpredictable menstrual bleeding, which with counselling is acceptable. The commonest reason for discontinuation still remains menstrual disorders and recent WHO workshops have investigated the cause of this bleeding and refined the reference periods of analysis. The method of action of progestogen-only systems is primarily cervical mucus blockade and prevention of sperm penetration. However, they also tend to produce a thinned atrophic endometrium. Ovarian effects ranging from complete anovulation to disordered luteal phase, persistent follicles and disorganised hormone production add to the contraceptive effect in more than half of the treatment cycles, but cause some of the menstrual disturbance. All these long acting methods are essential to family planning programmes, offering highly acceptable, and in some cases novel methods with high efficacy.

Administration, Intravaginal↗
PubMed1996

Effectiveness of pentoxifylline in semen preparation for intrauterine insemination.

Pentoxifylline, an inhibitor of cAMP phosphodiesterase activity, favours intracellular cAMP concentration increase. In-vitro treatment of semen with pentoxifylline leads to marked augmentation of sperm motility, enhancement of acrosome reaction, increase of sperm penetration into zona-free hamster oocytes, and protection of the sperm plasma membrane. Such properties indicate that the drug may be a useful tool for semen preparation in assisted reproduction, but its real effectiveness in improving fertilization rates is still uncertain, mainly in association with intrauterine insemination (IUI). Theoretically sperm motility should play an extremely important role for positive results in IUI. Therefore, a retrospective clinical trial was planned in order to evaluate whether addition of pentoxifylline to the previously standardized in-vitro treatment of semen had improved the percentage of pregnancies after homologous IUI. The study involved 55 sterile couples (33 classified infertile for male factor and 22 for other factors) who underwent a total of 150 cycles of homologous IUI: 101 for male factor infertility and 49 for other factors (anovulation n = 26, endometriosis n = 2, idiopathic n = 21). Out of the 101 cycles performed for male factor infertility, 61 underwent the standard preparation of semen and were followed by seven pregnancies (pregnancy rate = 11.5%) while 40 had a semen preparation with pentoxifylline addition and were followed by 11 pregnancies (pregnancy rate = 27.5%) with a significant difference between the two procedures (P < 0.05). Out of the 49 cycles carried out for factors different from male infertility, 10 underwent the standard preparation of semen and were followed by two pregnancies (pregnancy rate = 20.0%), while 39 had pentoxifylline addition and were followed by nine pregnancies (pregnancy rate = 23.1%). The difference between the two groups was not significant. Abortions and malformations were equally distributed in the standard treatment and in the pentoxifylline group.

Animals↗