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PubMed1990

Pulsatile luteinizing hormone secretion in women with polycystic ovary syndrome under clomiphene citrate. Differences between responders and nonresponders.

Although administration of Clomiphene Citrate (CC) is an effective therapy for ovulation induction in PCO patients, 15 to 20% of PCO patients do not ovulate following CC treatment. The aim of this study was to compare the endocrine dynamics (LH pulsatile pattern, FSH and steroid hormone changes) in 6 patients who ovulated (PCOS) and 6 PCO patients who did not ovulate in response to CC (PCOR). Blood was collected at 15 min intervals for 4 hr on day 9 of the first menstrual cycle (control cycle) and on day 9 of the following (treatment) cycle. In this cycle all women received 100 mg CC/day from day 5 to day 9. LH was determined in all samples whereas FSH and estradiol were measured every 60 min. No significant differences were observed regarding the age, body mass index, degree of hirsutism, ovarian volumes and basal levels of reproductive hormones between both groups of PCO women. During the control cycle, the LH pulse amplitude and transverse LH mean concentrations in PCOR patients were higher than in PCOR patients whereas the LH pulse frequency was similar in both groups. No difference was found in FSH and estradiol values between both groups. Compared to the control cycle, PCOR patients showed no change in the pulse amplitudes and no difference in LH, FSH and estradiol values following CC treatment. In contrast, during the CC therapy in PCOS patients an increase in the LH amplitude (p less than 0.05), the transverse mean LH concentration (p less than 0.05), FSH and estradiol was observed.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1994

[Clomiphene resistant PCO syndrome: IVF treatment as an alternative in failed gonadotropin treatment].

34 infertile patients with severe clomiphene-resistant polycystic ovary syndrome were treated with IVF/ET. Stimulation attempts with gonadotropins had resulted in multifollicular ovarian reactions, which did not allow standard ovulation induction using hCG due to the risk of multiple pregnancy. The resulting oocyte retrieval rates (87.4%/treatment cycle), embryo transfer rates (73.3%/oocyte retrieval) and pregnancy rates (24.2%/embryo transfer) approximately corresponded to the rates which are achieved in women with tubal failure using IVF/ET. Since strictly a maximum of 2 embryos was transferred, the occurrence of multiple pregnancies of higher degree could be avoided as opposed to standard gonadotropin therapy. The treatment so far only resulted in singleton pregnancies. The relatively high ovarian hyperstimulation rate (34.4%, primarily WHO stage I-II) could not be unequivocally lowered even by aspiration of all larger follicles.

Adult↗
PubMed2003

Clinical characteristics of patients with an abnormal clomiphene citrate challenge test.

OBJECTIVE: The study was undertaken to identify the clinical characteristics associated with an abnormal clomiphene citrate challenge (CC) test. STUDY DESIGN: The medical records of 123 women seen in a referral-based infertility practice who had a CC test as part of their infertility workup were reviewed. Eighty-five patients had a normal CC test and 38 patients had an abnormal test. Demographic, clinical, and laboratory characteristics were reviewed and analyzed. RESULTS: Women with abnormal CC tests were significantly older, had a lower mean body mass index, family history of early menopause, and shorter cycle intervals. Patients with an abnormal CC test had a pregnancy rate significantly lower than other women in this case series. CONCLUSION: Increased age, lower body mass index, shorter cycle intervals, lower cycle day 21 progesterone levels, and decreased pregnancy rates are associated with an abnormal CC test. Women with an abnormal CC test also tended to have a familial history of early menopause.

Adult↗
PubMed2003

Expression of glucosamine trisaccharides on the rat uterine surface is altered by clomiphene citrate. III. Relationship with implantation regimes and pregnancy.

The present study further elucidates the complex effects of a commonly-prescribed fertility drug upon a target organ in an animal model. In the human condition, its effects are rarely observed without the influence of endogenous ovarian hormones. The aim of the study was to investigate how the administration of a single dose of clomiphene citrate (CC) given prior to an implantation-priming sequence of ovarian hormones would affect the expression of surface oligosaccharides and membrane architecture of uterine epithelium. Ovariectomized rats were given a single dose of either 0.25 mg or 1.25 mg of CC prior to a hormone-priming regime of progesterone (P4) for 3 days with a single additional administration of oestradiol 17beta (E2) on day 3. Animals were killed 24 h after final treatment. Uterine tissue was labelled with the lectin Phytolacca americana conjugated with avidin, subsequently labelled with biotinylated ferritin and prepared for transmission electron microscopy. Results indicate that CC, when administered prior to the implantation hormone-priming regime, is able to act as a super oestrogen and upregulates expression of oligosaccharides on the plasma membrane surface and increases the density and length of microvilli on the surface of the cells when compared with other treatment regimes. Understanding of the effects of CC at the uterine level at the time of implantation enables manipulation of uterine receptivity to control fertility and to improve the outcome of assisted reproductive procedures.

Animals↗
PubMed2000

Expression of glucosamine trisaccharides on the rat uterine surface is altered by clomiphene citrate. II. Combination with ovarian hormones.

We used a single administration of clomiphene citrate (CC), a synthetic oestrogen that is prescribed for infertility treatment, in combination with either a single administration of oestradiol 17beta (E2) or progesterone (P4) to assess the combined effects of these hormones on the uterine surface. The aim of these experiments was to investigate how CC in combination with these hormones affected both expression of oligosaccharides on the uterine surface and membrane architecture further elucidating CC's agonistic/antagonistic properties. Ovariectomized sexually mature rats were given combinations of E2 and CC (E2 + CC) or P4 and CC (P4 + CC) or P4 and E2 (P4 + E2) and were killed 24 h later. Uterine tissue was labelled with the lectin Phytolacca americana conjugated with avidin and subsequently labelled with biotinylated ferritin and prepared for transmission electron microscopy. Results of the administration of these hormone combinations indicate that CC, when administered in conjunction with E2, had the ability to downregulate expression of oligosaccharides on the membrane surface caused by E2. When administered with P4, CC had the ability to upregulate the effects of P4. Thus, when combined with E2, CC has an antagonistic effect but when combined with P4, CC has an agonistic effect.

Acetylglucosamine↗
PubMed2003

Medical vs. surgical treatment for clomiphene citrate-resistant women with polycystic ovary syndrome.

This study was conducted to evaluate the efficacy of metformin compared with ovarian drilling in the treatment of clomiphene citrate (CC) resistant women with polycystic ovary syndrome. A total of 161 infertile, CC-resistant women with PCOS aged 22-34 years (mean 25.5 +/- 4.4) were evaluated prospectively during the period between January 2000 and December 2001. Patients were allocated into two groups; group 1 includes 64 women who received metformin, 850 mg twice daily throughout the cycle, and group 2 which includes 97 women who underwent laparoscopic ovarian drilling. If spontaneous ovulation or pregnancy was not achieved within 3 months after treatment, CC was added with increments of 50 mg (up to 150 mg/day) for both groups. Clinical and menstrual characteristics in addition to the hormonal profile were evaluated before and after the treatment. There were no significant differences between the two groups in terms of age, body weight, BMI, duration of infertility and serum hormone levels (androgens, gonadotrophins, insulin) before starting the treatment. A significant improvement in the regularity of menstrual cycles (P < 0.05) and a significant reduction in the serum levels of testosterone(P<0.01), androstenedione (P<0.01), DHEAS (P <0.05), LH (P<0.01) and LH:FSH ratio (P<0.05) were noted after the treatment. There were no significant differences between the metformin group compared with the drilling group in the rates of ovulation (79.7% vs. 83.5%) and pregnancy (64.1% vs. 59.8%). It is concluded that CC-resistant patients with polycystic ovary syndrome can be treated effectively either by metformin or by laparoscopic ovarian drilling. Menstrual cycle pattern and the rates of ovulation and pregnancy are improved significantly, due most probably to the significant decrease in the levels of androgens and luteinising hormone.

Adult↗
PubMed2005

Psychological side-effects of clomiphene citrate and human menopausal gonadotrophin.

OBJECTIVE: This study evaluated the psychological side-effects of clomiphene citrate (CC) and hMG in women undergoing fertility treatment. METHOD: This study was a cross-sectional, self-report survey of 454 women at various stages of treatment for infertility. At the time of study, 139 women had not taken fertility drugs and 315 women had taken one or more cycles of CC or hMG. All subjects were asked to complete the State-Trait Anxiety Inventory (STAI). Women taking CC or hMG were also asked to complete a self-administered questionnaire on the side-effects of their medications. RESULT(S): In the CC group (n = 162) and hMG group (n = 153), 77.8% (126 of 162) and 94.8% (145 of 153) reported at least one side-effect, respectively. Irritability, mood swings, feeling down, and bloating had high frequencies in both CC and hMG groups, with a higher mean number of side effects reported in the hMG group (4.4 +/- 3.7 for the CC group and 6.8 +/- 3.7 for the hMG group, p < 0.001). There was no significant difference among the CC, hMG and no medication groups for mean state and trait anxiety scores. However, there were significant differences among the three side-effect groups (those who reported 1 to 4, 5 to 7, and more than 7 side-effects) for the mean scores of state (df = 2, F = 8.7, p < 0.001) and trait (df = 2, F = 11.9, p < 0.001) anxiety in women taking fertility drugs. CONCLUSION(S): Women taking CC or hMG reported high frequencies of psychological side-effects, and should be advised of these before treatment.

Anxiety↗
PubMed2005

Metformin in the treatment of clomiphene citrate-resistant women with high BMI and primary infertility: clinical results and reproductive outcome.

The objective of this study was to evaluate the clinical and reproductive outcome in clomiphene-citrate (CC)-resistant women with high body mass index (BMI) and primary infertility. This was a case series based at the King Hussein Medical center, Amman, Jordan. Nineteen CC-resistant women with polycystic ovary syndrome (PCOS) who had high BMI and primary infertility were studied. All women received metformin monotherapy; 850 mg twice daily for a period of 6 months. If pregnancy occurred, metformin was continued for the first 12 weeks of pregnancy. The main outcome measures were a reduction in the BMI, resumption of regular menses, ovulation and pregnancy rates. Resumption of regular cycles was observed in 13 of 19 (68.4%) women. Ovulation and pregnancy were achieved in 9 (47.4%) and 6 (31.6%) of the 19 women, respectively. A significant reduction in the body weight after treatment reflected by a significant reduction in the BMI was noted. Metformin monotherapy is effective in CC-resistant women with morbid obesity and primary infertility and should be considered as first-line treatment in these patients.

Adult↗
PubMed2005

Follicle tracking of women receiving clomiphene citrate for ovulation induction.

Forty-five cycles of forty subfertile women were monitored with follicle tracking. Thirty women were anovulatory and 10 had unexplained infertility. Thirty women responded to the initial dose of Clomiphene Citrate (CC) and 10 remained anovulatory. Of those who ovulated with the first dose of CC, 25 developed one follicle, 2 developed 2 follicles and 3 developed three follicles. All the women that produced three follicles belonged in the unexplained infertility group. Eight women from the anovulatory group developed 1 follicle, two developed 2 follicles and 8 failed to respond. Provision of universal follicle tracking proved to be time consuming and required significant resources. Our results indicate that if there is a place for selective monitoring that should include women with unexplained infertility. We should also offer the first scan at around day 12 of the cycle as this could detect multiple follicle development. Patients with Polycystic Ovaries that start on 50 mgs of CC may not necessarily need follicle tracking as they usually do not respond to that dose.

Adult↗
PubMed2004

Management of anovulatory infertility associated with polycystic ovary syndrome: tamoxifen citrate an effective alternative compound to clomiphene citrate.

Clomiphene citrate (CC) is widely used as first-line treatment for ovulation induction in anovulatory women with polycystic ovary syndrome (PCOS). Tamoxifen citrate (TMX), another non-steroidal selective estrogen receptor modulator, may also be effective on the resumption of ovulation in these women. The aim of this controlled observational study was to compare the efficacy and safety of ovulation induction with TMX versus CC in anovulatory infertile women with PCOS. A total of 102 consecutive women (mean age+/-SD: 31+/-3.6 years; range: 26-38) with PCOS were studied. Following a spontaneous or progesterone-induced withdrawal bleed, women received either 50 mg daily of CC (days 2-6) or 20 mg daily of TMX (days 2-5). In case ovulation failed to occur, the dose was sequentially increased to 100 mg daily of CC and 40 mg daily of TMX, respectively. Serum progesterone levels were measured on cycle day 21 to monitor the ovulation pattern. The overall ovulation rate was significantly higher in women who received TMX compared with those who received CC (61/98, 62.2% vs. 60/127, 47.2%, p=0.03). Although not statistically significant, the pregnancy rate per ovulatory cycle was higher in the TMX group compared to the CC group (14/61, 22.9% vs. 11/60, 18.3%, respectively). All pregnancies were single and there were no side-effects in either group of treatment. Collectively, these data demonstrate that TMX is a safe and effective agent, and a suitable alternative to CC for anovulatory infertility in women with PCOS.

Adult↗
PubMed2005

Preoperative luteinizing hormone levels predict the ovulatory response to laparoscopic ovarian drilling in patients with clomiphene citrate-resistant polycystic ovary syndrome.

OBJECTIVE: Laparoscopic ovarian drilling (LOD) is a treatment option for women with clomiphene citrate (CC)-resistant polycystic ovary syndrome (PCOS), but appropriate indications for this procedure are lacking. The aim of this study was to analyze preoperative factors affecting the efficacy of LOD in producing ovulation in CC-resistant PCOS patients. DESIGN: Retrospective cohort study. PATIENTS AND METHODS: We studied 40 infertile Japanese women with CC-resistant PCOS who received LOD using argon-beam electrocoagulation. These patients satisfied the diagnostic criteria of the revised European Society of Human Reproduction and Embryology/American Society for Reproductive Medicine PCOS consensus. RESULTS: After LOD, ovulation occurred in 33 (83%) patients; pregnancy occurred in 22 patients (55%). Preoperative serum luteinizing hormone (LH) levels were significantly higher in women who ovulated after LOD than in those who did not ovulate. The area under the receiver operator characteristic curve for ovulation using preoperative LH levels was 0.81 (95% confidence interval: 0.67-0.96). After LOD, follicle-stimulating hormone levels increased significantly in the non-ovulating group but were unchanged in the ovulating group. CONCLUSIONS: Preoperative serum LH levels may be a good predictor of LOD efficacy in patients with PCOS. Therefore, eligibility criteria for LOD should be strictly applied, since LOD for patients with inadequate LH levels is not only ineffective, but also may impair ovarian reserve.

Adult↗
PubMed2006

Efficacy of laparoscopic ovarian diathermy in clomiphene citrate-resistant women with polycystic ovary syndrome: relationships with chronological and ovarian age.

BACKGROUND: Laparoscopic ovarian diathermy (LOD) has been used successfully as a first-, second- and third-line treatment for ovulation induction in women with polycystic ovary syndrome (PCOS). However, little is known about the predictors for LOD efficacy. The aim of the present study was to evaluate reproductive outcomes in clomiphene citrate (CC)-resistant PCOS patients treated with LOD according to ovarian and chronological age. METHOD: A total of 60 non-obese, primary infertile, CC-resistant women with PCOS were enrolled and treated with LOD. During the following 6 months, all patients underwent ovulation monitoring and timed intercourse. If spontaneous ovulation did not occur within 3 months from surgery, CC (100 mg/day) was administered for 5 days from day 3 of the remaining cycles. The ovulation, abortion and pregnancy rates were assessed and analyzed with patients categorized according to chronological age (group A, <25 years; group B, 25-30 years; group C, 30-35 years; group D, >35 years) and ovarian age (group 1, follicle stimulating hormone (FSH) < 10 mIU/ml; group 2, FSH > 10 mIU/ml). RESULTS: At the end of the study, total ovulation, pregnancy and abortion rates were 57.1, 13.0 and 18.2%, respectively. No difference in all reproductive outcomes was observed between groups A, B and C, whereas the efficacy of LOD was significantly lower in group D. A significant difference in all clinical endpoints was detected between groups 1 and 2. CONCLUSIONS: Our data show that chronological age >35 years and basal FSH value > 10 mIU/ml are related to poor reproductive prognosis in CC-resistant PCOS patients treated with LOD.

Abortion, Spontaneous↗
PubMed2006

Comparison of outcome of clomiphene citrate/human menopausal gonadotropin/cetrorelix protocol and buserelin long protocol--a randomized study.

This study evaluates the efficacy of a stimulation protocol with clomiphene citrate (CC)/human menopausal gonadotropin (hMG)/cetrorelix and its effects on oocyte quality and endometrium. One hundred and twenty couples with male-factor infertility who were about to undergo their first intracytoplasmic sperm injection cycles were randomized into two groups. Sixty women were stimulated with the CC/hMG/cetrorelix protocol (cetrorelix group) and 60 received the buserelin long protocol (buserelin group). Fewer oocytes were recovered in the cetrorelix group than in the buserelin group (mean +/- standard deviation (SD): 11.1 +/- 4.0 vs. 17.3 +/- 5.8, p < 0.001); however, the percentages of metaphase II, metaphase I and germinal vesicle oocytes were similar between the two groups. Serum estradiol level was significantly lower in the cetrorelix than in the buserelin group (mean +/- SD: 2600.58 +/- 1189.11 vs. 3293.46 +/- 1221.49 pg/ml, p = 0.006), but the endometrial thickness was similar. The implantation rates (19.2% vs. 17.7%) and the pregnancy rates (41.7% vs. 40.0%) were similar between groups. The ampoules (mean +/- SD: 18.9 +/- 3.0 vs. 38.9 +/- 12.2, p < 0.001) and injections (mean +/- SD: 6.8 +/- 1.1 vs. 15.7 +/- 3.1, p < 0.001) of gonadotropin used were significantly lower in the cetrorelix group than in the buserelin group. No patients in either group developed a premature luteinizing hormone surge. The present study found no statistically significant difference between the two treatment modalities with regard to pregnancy rates.

Adult↗
PubMed2006

Endometrial biopsy during induction of ovulation with clomiphene citrate in polycystic ovary syndrome.

BACKGROUND: The dichotomy between ovulation rates and pregnancy rates for women with polycystic ovary syndrome (PCOS) treated with clomiphene citrate (CC) prompted the present study to determine the effect of CC on endometrial maturity. METHODS: Retrospective case-control study of anovulatory women with PCOS (n = 119) on their third ovulatory cycle of CC and controls, 238 healthy regularly ovulating women whose partners had abnormal sperm, all of whom had an endometrial biopsy in the late luteal phase. RESULTS: Endometrial histology classified according to the classical Noyes criteria revealed out-of-phase endometrium in 19/119 (16%) of the CC group compared with 7/238 (3%) in controls (p < 0.0001). Duration of the luteal phase was not influenced by histological age of the endometrium. Endometrial biopsy performed during 138 conception cycles extracted from the database did not increase the miscarriage rate significantly (23.9%). CONCLUSIONS: CC treatment significantly increases the prevalence of out-of-phase endometrium and this could explain, in part, the large difference between ovulation and pregnancy rates. There was no correlation between the results of the endometrial biopsy and the duration of the luteal phase. Performing an endometrial biopsy during a conception cycle does not seem to have a significant negative effect on the outcome of pregnancy.

Adult↗
PubMed2002

Clomiphene citrate does not adversely affect endometrial leukemia inhibitory factor levels.

The aim of this study was to compare endometrial leukemia inhibitory factor (LIF) levels in spontaneous and clomiphene citrate (CC)-induced cycles of patients with unexplained infertility. The patients were followed in two consecutive cycles. Endometrial samples were obtained 7 days after ultrasonographic evidence that ovulation has occurred during the spontaneous cycle, then the patients were induced with CC from day 5 to day 9 during the subsequent cycle with 50 mg/day, and ovulation monitoring and endometrial biopsy were performed in the same manner. The samples were obtained using a Pipelle biopsy device without using local anesthesia, and kept in formaldehyde solution until the day of measurement. Then they were homogenized in phosphate buffered distilled water, and LIF levels were detected in the homogenized fluid by ELISA method. Endometrial LIF levels were 470 +/- 52 and 501 +/- 45 pg/1 gram wet tissue in spontaneous and CC-induced cycles respectively, revealing no significant difference. Ovulation induction with CC did not adversely affect endometrial LIF levels.

Abortion, Spontaneous↗
PubMed1996

Complete and partial luteinized unruptured follicle syndrome after ovarian stimulation with clomiphene citrate/human menopausal gonadotrophin/human chorionic gonadotrophin.

A total of 31 clomiphene citrate/human menopausal gonadotrophin (HMG)/human chorionic gonadotrophin (HCG)-stimulated cycles in 28 patients were investigated to determine the fate of each of the matured follicles. A standard stimulation regimen was adhered to, and ultrasound as well as hormonal monitoring was performed. All follicles were measured by vaginal ultrasound at -12, +35 and +45 h relative to HCG administration and at 7 days after HCG administration. Of the 220 follicles, 107 (48.6%) ruptured. The number of ruptured follicles per cycle was correlated with the mid-luteal progesterone concentration (r = 0.63, P = 0.0005). The probability of follicular rupture was related to follicular diameter at 12 h before HCG administration; 6% of follicles < 12 mm in diameter ruptured compared with 87% of follicles 18-19 mm. A complete luteinized unruptured follicle (LUF) syndrome was observed in six cycles (20%). In these cycles, follicular growth and oestradiol, progesterone, luteinizing hormone (LH) and follicle stimulating hormone (FSH) concentrations at 12 h before HCG administration were similar to those in cycles with follicular rupture. However, mid-luteal progesterone concentrations were lower in complete LUF cycles (46.97 +/- 8.95 nmol/l versus 108.74 +/- 12.27 nmol/l; P = 0.02). These data demonstrate that in stimulated cycles many follicles, usually the smaller ones, fail to rupture, even after HCG administration. Complete LUF syndrome, despite a strong exogenous ovulatory signal, and the absence of any difference in peri-ovulatory hormonal parameters, indicates that the defect causing LUF resides in the follicle itself and/or hormonal changes during the follicular phase.

Chorionic Gonadotropin↗
PubMed1997

Intrauterine insemination after ovarian stimulation with clomiphene citrate: predictive potential of inseminating motile count and sperm morphology.

This retrospective study aimed to evaluate the prognostic value of the inseminating motile count (IMC) and sperm morphology (using strict criteria) on success rates after homologous intrauterine insemination (IUI) combined with clomiphene citrate (CC) stimulation. A total of 373 couples underwent 792 IUI cycles in a predominantly (87.4%) male subfertility group. The overall cycle fecundity (CF) and baby take-home rate (BTH) was 14.6 and 9.9% respectively. The cumulative CF and BTH (per couple) after three cycles were 30.6 and 21.1% respectively. Overall, sperm morphology and IMC were of no prognostic value using receiver operating characteristic (ROC) curve analysis, but after classifying the study population into different subgroups according to IMC, sperm morphology turned out to be a valuable prognostic parameter in subgroup 1, i.e. IMC <1 x 10(6). In this subgroup, no pregnancies were seen when the morphology score was <4% and the mean value of sperm morphology was significantly different in the pregnant (8.3%) versus non-pregnant group (5.0%; P <0.05). The cumulative CF and BTH after three IUI cycles were comparable for all couples with the exception of those cases in which the IMC was <1 x 10(6) with a morphology score of <4% normal forms. We recorded only two twin pregnancies (2.5%) and no moderate or severe ovarian hyperstimulation syndrome. We conclude that in a selected group of patients without CC resistance and normal ovarian response following CC stimulation [maximum of three follicles with a diameter of >16 mm at the time of administration of human chorionic gonadotrophin (HCG)], IUI combined with CC-HCG can be offered as a very safe and non-expensive first-line treatment, at least with an IMC of >1 x 10(6) spermatozoa. In cases with <1 x 10(6) spermatozoa, CC-IUI remains important as a first-choice therapy provided the morphology score is > or =4%.

Adult↗