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PubMed1993

The effect of clomiphene citrate and menopausal gonadotropins on cervical mucus in ovulatory cycles.

OBJECTIVE: To determine the effect of clomiphene citrate (CC) and hMG on cervical mucus (CM), optimally sampled in the periovulatory period from confirmed ovulatory cycles, in the dosage range commonly employed for ovulation induction. DESIGN: Controlled, observational. SETTING: Infertility treatment center at a university medical center. PATIENTS: One hundred fifty-four infertile patients undergoing 161 treatment cycles in which postcoital test was performed in a documented ovulatory cycle. INTERVENTION: One hundred six patients received CC at dosages of 50 to 200 mg. Twenty patients received hMG at dosages of 75 to 225 IU. Thirty-seven patients sampled during spontaneous ovulatory cycles served as controls. MAIN OUTCOME MEASURE: Cervical mucus score using standardized scoring criteria. RESULTS: Subjects receiving CC at all dosages had significantly lower CM scores 8.6 +/- 0.5, compared with patients receiving hMG 11.0 +/- 0.6 or spontaneous cycles 12.1 +/- 0.5. The incidence of unfavorable CM (score < 10/15) was similar in patients receiving CC at dosages of 50 mg (48.1%), 100 mg (48.6%), and 150 to 200 mg (60%). CONCLUSIONS: Cervical mucus scores are reduced in ovulatory cycles after CC administration compared with both spontaneous ovulatory cycles and in patients undergoing superovulation with hMG. The reduction in CM scores was similar at all dosages of CC studied. The lack of adverse effects on CM during hMG therapy supports a local antiestrogenic effect of CC at the level of the cervix.

Adult↗
PubMed1994

Evaluation of clomiphene citrate and human chorionic gonadotropin treatment: a prospective, randomized, crossover study during intrauterine insemination cycles.

OBJECTIVE: To test the hypothesis that in couples undergoing IUI, actively managed cycles using clomiphene citrate (CC) stimulation, ultrasound monitoring, and hCG timing will result in increased pregnancy rate (PR) per cycle compared with unstimulated urinary LH-timed cycles. PATIENTS: Fifty-six couples with unexplained infertility (n = 26) or male factor infertility (n = 30) participated in the study. SETTING: Tertiary academic medical center. DESIGN: Prospective, randomized, crossover. Couples were randomized initially to one of the two study groups (treatment A: LH-timed IUI; treatment B: CC-stimulated, hCG-timed IUI). If no pregnancy occurred, each couple alternated between the two regimens during subsequent cycles, up to a total of four cycles. RESULTS: Twenty-nine couples completed the study and the analysis of 95 cycles revealed that among the male factor infertility group, one pregnancy occurred during the 26 cycles of each treatment group (PR per cycle of 3.9% for both treatment groups). In contrast, among the unexplained infertility group, there was a marked difference in the effect of treatments. During treatment A only one pregnancy occurred in 20 cycles (PR of 5% per cycle) whereas during treatment B, six pregnancies occurred in 23 cycles (PR of 26.1% per cycle). CONCLUSIONS: If IUI is chosen as the treatment modality in unexplained infertility, the addition of active ovulation management that includes CC stimulation, ultrasound monitoring of folliculogenesis, and hCG timing of ovulation increases the PR per cycle. In couples with male infertility, PR per cycle is low and is apparently not affected by the addition of active ovulation management.

Adult↗
PubMed1994

Optic neuropathy associated with clomiphene citrate therapy.

A 31-year-old woman developed acute visual loss in her right eye immediately after a 5-day course of CC for primary infertility. Although she gradually recovered vision, she did not return to 20/20 acuity in that eye. As CC may cause vascular sludging, it is hypothesized that increased blood viscosity resulted in sufficiently reduced flow in a posterior ciliary artery to produce an anterior ischemic optic neuropathy. Patients experiencing visual symptoms while taking clomiphene should have their eyes examined promptly for evidence of visual changes or optic nerve injury.

Adult↗
PubMed1994

Serum progesterone predicts abnormal gestations in clomiphene citrate conception cycles as well as in spontaneous conception cycles.

OBJECTIVE: To determine if a "discriminatory" P concentration could be established that predicted abnormal early pregnancies in clomiphene citrate (CC)-conceived cycles. DESIGN: Progesterone concentrations of gestations between 28 and 49 days from last menstrual period in both spontaneously conceived and CC-stimulated cycles were analyzed using a relative-operating characteristic (ROC) curve. INTERVENTIONS: Serum P concentrations were measured in 222 pregnant patients from the first 49 days of gestation. One hundred sixteen patients conceived in a spontaneous cycle and 106 patients conceived in CC-treated cycles. Two by two contingency tables were used to calculate the true-positive (sensitivity) and false-positive rates at 20 specific P at 20 specific P concentrations. A ROC curve was then generated by plotting the sensitivity of the test against the percent of normal patients incorrectly classified (false positive) at each P level. The best discriminatory value was estimated in each curve at a point of high sensitivity associated with a minimal false-positive value. The areas under the curve and SE were calculated for each group and compared by the critical ratio z-test. RESULTS: The best discriminatory P concentration was 10 ng/mL (32 nmol/L) for spontaneously conceived pregnancies and 30 ng/mL (95 nmol/L) for CC-treated pregnancies. The area under each ROC curve was significantly predictive. Comparison of the two curves indicated that the ability of P measurements to predict gestational complications was independent of follicular stimulation. CONCLUSIONS: Follicular stimulation with CC increases the discriminatory P value that predicts gestational normalcy but does not alter the clinical utility of the test.

Abortion, Spontaneous↗
PubMed1994

Cycle abnormalities in infertile women with regular menstrual cycles: effects of clomiphene citrate treatment.

OBJECTIVE: To investigate the incidence and nature of cycle abnormalities and the effect of clomiphene citrate (CC) treatment in women with apparently ovulatory cycles and unexplained infertility. DESIGN: Nonrandomized, open study of patients before and during treatment. SETTING: The Reproductive Medicine Clinic of a District General Hospital. PATIENTS: Thirty-five women with regular, apparently ovulatory menstrual cycles and unexplained infertility. INTERVENTIONS: Detailed ultrasound and hormonal cycle tracking was performed before and during treatment with CC. MAIN OUTCOME MEASURES: Serial ultrasound scans and measurements of serum LH, FSH, E2, and P. RESULTS: Before treatment, 54% of cycles were uniovulatory, 40% were characterized by cyst formation, and 6% were characterized by poor follicular growth. Fifty-one percent of pretreatment cycles had normal hormone profiles, 31% had defective luteal phases, 14% had increased early follicular phase serum FSH levels, and 9% had increased early follicular phase serum LH levels. Treatment with CC reduced the incidence of cyst formation to 9% and the incidence of luteal phase defects to 3%. However, 28% of CC-treated cycles showed ultrasound features of overstimulation and 51% had high follicular phase E2 peaks so that only 34% of CC-treated cycles had normal hormone profiles. CONCLUSIONS: Cycle abnormalities are common in unexplained infertility. The incidence of cyst formation and luteal phase defects, the most common abnormalities in this group, is reduced by CC treatment.

Adult↗
PubMed1994

Transvaginal ultrasonic assessment of the response to clomiphene citrate in polycystic ovarian syndrome.

OBJECTIVE: To study the relationship between some ovarian morphological findings based on transvaginal ultrasound (US) and the clomiphene citrate (CC) responsiveness in patients with polycystic ovarian syndrome (PCOS). DESIGN: A comparative study of ovarian US features between the CC responders and the CC nonresponders. SETTING: Infertility and Endocrine Clinic, Department of Obstetrics Gynecology, Shimane Medical University Hospital, Izumo, Japan. PATIENTS: Forty-seven infertile patients with PCOS and 30 healthy volunteers. INTERVENTIONS: A dose of 50 to 200 mg/d CC was given for ovulation induction in patients with PCOS. MAIN OUTCOME MEASURES: Ovarian volume and number of follicles; serum LH, FSH, T, delta 4 androstenedione, and DHEAS. RESULTS: The mean ovarian volume (11.9 mL) and the number of small follicles (13.0) were significantly larger in the CC nonresponders compared with those of the CC responders (7.9 mL and 7.0, respectively). Only 47% of the CC responders and 79% of the CC nonresponders had bilaterally enlarged ovaries (> 6.2 mL). Considerable overlap existed between the different groups. However, 96% of the CC nonresponders had a significantly increased number of follicles (> or = 10 follicles) in each ovary compared with that (16%) of the CC responders. Furthermore, with the combination of these parameters, none of the CC nonresponders had bilaterally normal ovaries, and 96% of patients with PCOS with bilaterally abnormal ovaries were CC nonresponsive. CONCLUSIONS: Small multiple follicles (> or = 10) and enlarged ovarian volume (> 6.2 mL) were the most prominent transvaginal US features of ovaries in patients with PCOS with CC nonresponsiveness. These US features could be clinically useful for distinguishing clearly a CC nonresponder from a CC responder.

Adolescent↗
PubMed1995

Clomiphene citrate reduces serum insulin-like growth factor I and increases sex hormone-binding globulin levels in women with polycystic ovary syndrome.

OBJECTIVES: To evaluate the effect of clomiphene citrate (CC) on circulating levels of insulin-like growth factor I (IGF-I) and sex hormone-binding globulin (SHBG) in patients with polycystic ovary syndrome (PCOS). DESIGN: Prospective open trial. PATIENTS: Eight women with clinical and biochemical evidence of PCOS. INTERVENTION: One hundred fifty milligrams CC was administered orally for 5 days. MAIN OUTCOME MEASURES: Serum IGF-I, SHBG, LH, FSH, and E2 levels were determined for 8 days, beginning 3 days before CC treatment. RESULTS: A progressive decline in serum IGF-I levels was observed in all subjects reaching a maximum of 30% on the 5th day of therapy (40.6 +/- 5.1 to 28.7 +/- 4.0 nmol/L [conversion factor to SI unit, 0.13]). This was correlated inversely with the expected rises in LH, FSH, and E2 levels. Concomitantly, there was a 23% rise in SHBG levels. The absolute decrease of IGF-I levels was negatively correlated with age and was independent of body mass index. CONCLUSIONS: These observations suggest that oral administration of CC has an impact on the IGF-I and SHBG systems, which may be involved in the initiation of ovulatory function in PCOS.

Adolescent↗
PubMed1995

Effect of laparoscopic ovarian electrocautery on ovarian response and outcome of treatment with gonadotropins in clomiphene citrate-resistant patients with polycystic ovary syndrome.

OBJECTIVE: To evaluate the effect of ovarian electrocautery on the ovarian response to gonadotropic stimulation and pregnancy rate (PR) in clomiphene citrate (CC)-resistant women with polycystic ovary syndrome (PCOS) and high basal serum LH levels. DESIGN: Retrospective study. SETTING: Outpatient infertility clinic in a tertiary referral center. SUBJECTS: Twenty-two women with PCOS, high basal serum LH concentrations, and CC resistance who underwent laparoscopic ovarian electrocautery. Treatment with gonadotropin was scheduled after failure to ovulate spontaneously or conceive after electrocautery. Data from gonadotropin-stimulated cycles were compared with data from treatment cycles in the same patients before ovarian electrocautery. MAIN OUTCOME MEASURES: Number of ampules, duration of induction phase, daily effective dose, PR, and pregnancy outcome. RESULTS: Markedly reduced basal serum LH concentrations and normal menstrual cyclicity in 41% of patients were recorded after laparoscopic ovarian electrocautery. Comparison of gonadotropin-stimulated cycles before and after electrocautery revealed significantly higher rates of ovulation and pregnancy after electrocautery as well as significant reduction in the number of ampules, daily effective dose, and duration of the induction phase with hMG and in daily effective dose with FSH. CONCLUSIONS: Our results indicate an increased ovarian sensitivity to gonadotropins after laparoscopic ovarian electrocautery. A preference for laparoscopic ovarian electrocautery over medical treatment in all or selected groups of CC-resistant PCOS patients is suggested.

Adult↗
PubMed1995

Clomiphene citrate and neural tube defects: a pooled analysis of controlled epidemiologic studies and recommendations for future studies.

OBJECTIVE: To estimate the degree to which neural tube defects (NTDs) are associated with periconceptional clomiphene citrate (CC) exposure in controlled epidemiologic studies, to investigate the consistency of study findings with respect to this association, and to identify key problems that future studies should address. DESIGN: Pooled analysis of 10 epidemiologic studies. SETTINGS: Hospitals and clinics. PATIENTS: Women undergoing treatment for infertility. INTERVENTIONS: Oral administration of CC. MAIN OUTCOME MEASURE: Prevalence ratio for NTDs. RESULTS: Ten controlled epidemiologic studies were identified that supplied sufficient data on CC and NTDs for inclusion. The estimated ratio of NTD prevalence among CC-exposed versus unexposed pregnancies ranged from 0.55 to 5.73 among the studies, but the variation was compatible with random fluctuation. The estimated summary prevalence ratio was 1.08, with 95% confidence limits of 0.76 and 1.51. CONCLUSION: This analysis indicates that an elevation in NTD risk due to CC cannot be ruled out, but any such elevation seems likely to be less than twofold, and there may be no elevation at all. Future studies should be designed to avoid several methodological problems not addressed in studies to date.

Administration, Oral↗
PubMed1996

Clomiphene citrate with intrauterine insemination: is it effective therapy in women above the age of 35 years?

OBJECTIVES: To evaluate the influence of female age on clomiphene citrate (CC) with IUI therapy and to compare the efficacy of this therapy between patients with ovulatory and anovulatory infertility. SETTING: A university fertility clinic. SUBJECTS: Six hundred sixty-four CC with IUI cycles from 290 women aged 22 to 48 years. MAIN OUTCOME MEASURES: Cumulative and clinical pregnancy rates (PRs). RESULTS: Both cumulative and clinical PRs declined substantially in women > 35 years when compared with those < or = 35 years. In addition, no difference in these parameters was noted between patients with ovulatory and anovulatory infertility diagnoses. The vast majority of pregnancies occurred within the first four treatment cycles, irrespective of age or ovulatory versus anovulatory infertility diagnoses. CONCLUSIONS: The age-related decline in clinical PR is most rapid beginning at the age of 35 years. For any given age group, CC with IUI therapy has similar cumulative and clinical PRs for both ovulatory and anovulatory infertility diagnoses. This therapy usually should not extend beyond four cycles. Couples should be counseled about the dramatic fall in PRs occurring beyond the age of 35 years.

Adult↗
PubMed1996

Efficacy of selection criteria for ovarian reserve screening using the clomiphene citrate challenge test in a tertiary fertility center population.

OBJECTIVE: To examine selection criteria for ovarian reserve screening. DESIGN: Retrospective study. PATIENTS: Two hundred nineteen women underwent testing for ovarian reserve for woman's age > 35 years, any age with unexplained infertility, one ovary, or a poor response to hMG. INTERVENTIONS: Clomiphene citrate challenge test. MAIN OUTCOME MEASURES: Frequency of abnormal ovarian reserve screening, menstrual cycle parameters, response to hMG, and pregnancy outcome by screening criteria. RESULTS: One hundred eighty-four (84.0%) women had a normal ovarian reserve screening test; 35 (16.0%) had an abnormal ovarian reserve screening test. Twenty-six had abnormal ovarian reserve screening when screened by age, 14 for unexplained infertility, 5 for poor response to hMG, and 6 for one ovary. Fifteen women with abnormal ovarian reserve screening had more than one indication for screening. For women attempting pregnancy (n = 182), 49 of 148 (33.1%) with normal ovarian reserve screening became pregnant compared with 2 of 34 (5.9%) with abnormal ovarian reserve screening. Within each screening category, women with abnormal ovarian reserve had menstrual cycle parameters associated with a short follicular phase, required more hMG, and responded poorly to hMG. CONCLUSIONS: One of six women undergoing ovarian reserve screening had an abnormal test, which was associated a poor reproductive outcome. Age was the most important single criteria. Selected ovarian reserve screening is simple and inexpensive and should be offered to all fertility patients meeting the specific screening criteria listed above.

Adult↗
PubMed1996

Ovulation induction in clomiphene-resistant anovulatory women with normal dehydroepiandrosterone sulfate levels: beneficial effects of the addition of dexamethasone during the follicular phase.

OBJECTIVE: To evaluate the effect on ovulation of a 10-day course of dexamethasone (DEX) initiated concurrently with a 5-day course of clomiphene citrate (CC) in CC-resistant patients with normal DHEAS levels. DESIGN: Retrospective review. SETTINGS: Patients from the clinical practice of the authors at the Medical College of Georgia, Augusta, Georgia. PATIENTS: Thirteen oligomenorrheic women with normal DHEAS levels who failed to ovulate on a graduated regimen of CC up to a dose of 150 mg for 5 days. INTERVENTIONS: Ten-day course of DEX initiated concurrently with a 5-day course of CC; ovulation and pregnancy outcomes recorded. MAIN OUTCOME MEASURE: Pregnancy. RESULTS: Eleven of 13 women had evidence of ovulation. Five clinical pregnancies were achieved. CONCLUSION: These initial data support improvements in follicular development with an overlapping follicular phase regimen of CC and DEX in patients with normal DHEAS levels and a previous poor response.

Adult↗
PubMed1996

Luteal support with both estradiol and progesterone after clomiphene citrate stimulation for in vitro fertilization.

OBJECTIVE: To determine if pregnancy rates (PRs) for clomiphene citrate (CC)-stimulated IVF-ET can be increased by luteal support with E2 and P. DESIGN: Prospective randomized crossover clinical study. SETTING: Infertile women volunteers in an academic research environment. PATIENTS: Ninety-three infertile women underwent a total of 143 IVF-ET cycle using CC for ovulation induction. INTERVENTIONS: Each woman received either no luteal support (control group) or luteal support with both oral E2 (2 mg three times daily) starting on the day of retrieval and vaginal P suppositories (100 mg twice daily) starting on the day of ET. MAIN OUTCOME MEASURE: Clinical PR. RESULTS: In 79 of 143 (55%) of the cycles, at least one embryo was transferred. Compared with the control group (n = 35 cycles), the luteal support group (n = 44 cycles) had a significantly higher PR per retrieval (control: 2% versus luteal support: 16%) and were older (control: 33 +/- 4 versus luteal support: 35 +/- 4 years; mean +/- SEM). They did not differ in terms of E2 or P levels, endometrial thickness on the day of hCG, number of follicles > 16 mm in diameter, mature oocytes retrieved, or embryos transferred. CONCLUSIONS: Luteal support with both E2 and P significantly increase the clinical PRs for CC-stimulated IVF-ET.

Adult↗
PubMed1996

An extended 10-day course of clomiphene citrate (CC) in women with CC-resistant ovulatory disorders.

OBJECTIVE: To evaluate the effectiveness of extended duration clomiphene citrate (CC) (100 mg for 10 days) as an alternative to complex ovulation induction strategies for women who fail to ovulate despite standard incremental doses of CC of > or = 150 mg for 5 days. DESIGN: Retrospective case series. SETTING: University-based infertility practice. PATIENT(S): Thirty women with CC-resistant World Health Organization group II ovulatory disorders. INTERVENTION(S): At least one cycle of 100 mg CC from days 3 to 12. RESULT(S): Fourteen patients (47%) ovulated during 31 of their 48 cycles (65%). Five women (17%) conceived a total of seven singleton pregnancies, including five term deliveries and two spontaneous abortions. Weight, body mass index, and the presence of hyperandrogenism did not predict responsiveness to the extended duration CC. Side effects were similar to those reported during standard CC treatment. CONCLUSION(S): An extended 10-day course of CC provides a simple, noninvasive, and inexpensive alternative for a subset of women with ovulatory disorders that are refractory to standard CC treatment.

Adult↗
PubMed1987

Prediction of ovulation with the use of oral and vaginal electrical measurements during treatment with clomiphene citrate.

This study was undertaken to evaluate the usefulness of measuring salivary and vaginal electrical resistance in monitoring ovulation induced by clomiphene citrate (CC). Data from 28 cycles of 12 women treated with CC were compared with those of 18 cycles of 13 women who were ovulating spontaneously. Patterns of salivary readings in CC and spontaneous cycles were similar and showed a preovulatory peak 6.2 (mean) days before the luteinizing hormone peak. The trend in vaginal readings for CC cycles differed from that of spontaneous ovulations in that the values were depressed during and shortly after CC therapy. Occurrence of the periovulatory nadir and subsequent rise was common to both groups. The rise in vaginal readings CC cycles occurred within 24 hours of the luteinizing hormone peak in 88% of cases. Retrospective analysis showed that, based on this method, artificial insemination would have been timed appropriately in 25 of 27 cycles or in every cycle, depending on the protocol used. The results indicate that the method is equally useful for predicting and confirming ovulation in cycles in which CC was used to induce ovulation as it is in spontaneous cycles.

Adult↗
PubMed1987

Timing of nuclear maturation and cumulus dissociation in human oocytes stimulated with clomiphene citrate, human menopausal gonadotropin, and human chorionic gonadotropin.

The maturation of the preovulatory human follicle larger than 16 mm is described between 0 and 36 hours after human chorionic gonadotropin (hCG) administration. The nuclear evolution of the oocyte is timed: prophase at 14 hours, germinal vesicle breakdown at 15 hours, metaphase I at 20 hours; metaphase II is complete by 35 hours. The quantified expansion of the cumulus is related to nuclear evolution. Almost complete expansion may already be observed 18 hours before ovulation (20 hours after hCG). The specific action of clomiphene citrate, human menopausal gonadotropin, and hCG stimulation on the granulosa induces a more rapid luteinization than is found after other means of stimulation or in spontaneous cycles. Oocytes from follicles less than or equal to 16 mm on preovulatory ovaries often show a reaction to hCG that may be related to their subsequent quality.

Adult↗
PubMed1987

Mature and immature oocytes in large and medium follicles after clomiphene citrate and human menopausal gonadotropin stimulation without human chorionic gonadotropin.

After ovarian stimulation with clomiphene citrate combined with human menopausal gonadotropin, 24 large (greater than 16 mm) and 16 medium (7 to 15 mm) human follicles were classified according to plasmatic estradiol (E2), luteinizing hormone (LH), and histology of the follicle and oocytes (in thin sections). An asynchronism of several hours between the stage of development of the largest and large cohort follicles is observed; overripeness of oocyte cumulus complex (OCC) is revealed. An asynchronous response to gonadotropins in granulosa and cumulus is also seen in the cohort of medium follicles of the same ovary, but not resumption of nuclear maturation of the oocyte. The efficiency of these oocytes after fertilization is discussed.

Adult↗
PubMed1987

Utilization of the biochemical response to clomiphene citrate for the selection of women with hypothalamic amenorrhea who require further investigation.

Clomiphene citrate (CC) 100 mg daily for 5 days was given to 41 women with hypothalamic amenorrhea. CC also was given to 6 similar women with known organic suprasellar disease and to 8 normal women in the early follicular phase. Serum luteinizing hormone (LH), follicle-stimulating hormone (FSH), and estradiol (E2) were measured both before the first tablet of CC and again on the fifth day. Biochemical evidence of ovulation occurred in 12 of the 41 women. The remaining 29 women included 14 with a significant rise in one or more of serum LH, FSH, and E2 similar to the normal group. The 15 women without rise in any hormonal parameter were investigated further because their response was similar to the organic suprasellar disease group. Serious organic sellar/suprasellar disease was initially found in 4 women, while 2 of the remaining 11 subsequently developed previously unrecognized organic disease over the ensuing year. The authors conclude that the biochemical response to CC is useful to indicate which women with hypothalamic amenorrhea--without any other obvious clinical stigmata--should be further investigated for underlying organic disease.

Amenorrhea↗