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PubMed1999

Prospective randomized double-blind trial of the correlation between time of administration and antiestrogenic effects of clomiphene citrate on reproductive end organs.

OBJECTIVE: To investigate whether the timing of administration of clomiphene citrate (CC) affects hormone levels, follicular recruitment, reproductive end organs, and pregnancy rates. DESIGN: Prospective, randomized, double-blind trial. SETTING: Academic center. PATIENT(S): Twenty-three patients with unexplained infertility. INTERVENTION(S): Twenty-three patients with unexplained infertility underwent 45 cycles of CC and IUI. For each cycle, patients were randomized either to receive 100 mg of CC on days 1-5 and placebo on days 5-9 (study group), or placebo on days 1-5 and CC on days 5-9 (control group). MAIN OUTCOME MEASURE(S): The difference in uterine artery PI, number of follicles, endometrial thickness, and pregnancy rates. RESULT(S): Gonadotropins and E2 levels, as well as uterine artery pulsatility index, were significantly higher in the study group on day 5. In addition, in the study group, a longer time interval existed between finishing CC and IUI (8 versus 6 days; MD = 2 days; 95% CI = 1-3) and the pregnancy rate was higher than in the control group (6 versus 0; OR = 15.1; 95% CI = 1.1-72.4). CONCLUSION(S): Clomiphene citrate commenced on day 1 of the menstrual cycle, rather than day 5, results in more rapid follicular growth, a longer CC-free period before IUI, and higher pregnancy rates. Although methodologically sound, our results should be taken with some degree of caution because they are based on a relatively small number of patients.

Adult↗
PubMed1999

Prospective, randomized, crossover study to evaluate the benefit of human chorionic gonadotropin-timed versus urinary luteinizing hormone-timed intrauterine inseminations in clomiphene citrate-stimulated treatment cycles.

OBJECTIVE: To compare two methods of timing IUI, urinary LH monitoring and transvaginal ultrasonography/ hCG timing of ovulation, in patients receiving clomiphene citrate. DESIGN: Prospective, randomized, crossover study. SETTING: Yale University Reproductive Medicine Center. PATIENT(S): Infertile couples undergoing IUI because of unexplained infertility, anovulation, or male factor infertility. INTERVENTION(S): Patients received clomiphene citrate on days 3-7 of the menstrual cycle and were randomized initially to one of two monitoring protocols. In protocol A, urinary LH monitoring was used to time IUI. Urinary LH levels were determined daily with the use of commercial kits, starting on day 10 of the cycle. When urinary LH was detected, IUIs were performed daily for the next 2 days. In protocol B, ultrasound monitoring of folliculogenesis was performed until a leading follicle of > or = 18 mm was noted, at which time hCG (10,000 IU) was given intramuscularly and IUIs were performed daily for the next 2 days. If no pregnancy occurred, the couple crossed over to the alternate protocol for the next cycle and continued this alternating therapy for a total of four cycles. MAIN OUTCOME MEASURE(S): Pregnancy rate per cycle. RESULT(S): One hundred forty-one cycles were completed. In these cycles, six pregnancies occurred, for an overall pregnancy rate of 4.26% per cycle. The pregnancy rate with LH-timed IUI was 4.29% (3/70) and that with hCG-induced ovulation was 4.23% (3/71); the difference was not statistically significant. CONCLUSION(S): Timing IUI with the use of a relatively expensive and time-consuming method such as ultrasound monitoring of folliculogenesis and hCG induction of ovulation does not appear to produce an increased pregnancy rate over urinary LH monitoring of ovulation.

Adult↗
PubMed2003

Follicular growth, endometrial thickness, and serum estradiol levels in spontaneous and clomiphene citrate-induced cycles.

OBJECTIVES: To evaluate follicular growth, endometrial thickness, and serum estradiol levels in spontaneous cycles and cycles induced by clomiphene citrate (CC). METHODS: A 2-year prospective study of spontaneous cycle followed by a CC-induced cycle to compare paired data. Twenty couples with unexplained infertility were recruited from the Infertility Clinic of the Jawaharlal Institute of Postgraduate Medical Education and Research. An oral dose of 150 mg of CC was administered on days 5 through 9 of the CC-induced cycle. Each woman was evaluated using transvaginal sonography and serum estradiol level estimation from day 10 of the menstrual cycle until ovulation. Results were analyzed using the paired t-test. RESULTS: The leading follicular diameter was significantly larger, endometrial thickness was significantly decreased, and serum estradiol levels were significantly higher in the follicular phase of CC-induced cycles. CONCLUSIONS: Clomiphene citrate-induced cycles showed different follicular, endometrial growth patterns, and serum estradiol levels compared with spontaneous cycles.

Adult↗
PubMed1985

Evaluation of sperm parameters in clinical trial with clomiphene citrate of oligospermic men.

A randomized group of 101 oligospermic men, with low or normal serum follicle-stimulating hormone levels and infertile marriages of more than 2 years were studied with and without clomiphene citrate. For 6 to 9 months 56 patients were treated with 50 mg. clomiphene citrate daily and 45 men were given no treatment. Significant improvement in volume, sperm density and sperm motility was observed in the treated group but not in the control group. Sperm density greater than 20 times 10(6) per ml. was obtained in 18 men and there were 7 pregnancies in the treated group. In the control group 3 men had a sperm count greater than 20 times 10(6) per ml. and there was no pregnancy. This study showed statistically significant improvement in sperm parameters in the treated group but not in the untreated patients.

Clinical Trials as Topic↗
PubMed1976

Clomiphene citrate in the management of male infertility.

There were 35 hypofertile men who underwent assay of serum follicle stimulating and luteinizing hormones, and testosterone, and were placed in a trial program using clomiphene citrate in a 25-day cycle, with 5-day rest periods. Therapy has been maintained for up to 9 months with a projected termination of 12 months. No relationship could be established between serum follicle stimulating hormone and spermatozoal number in this population. The spermatozoal count improved in 31 men while they were on therapy and 8 pregnancies have occurred. Clomiphene citrate seems to be effective in improving the quanttity of spermatozoa and the spermatozoal motility in these hypofertile men.

Clomiphene↗
PubMed1975

Effect of clomiphene on the ponderal, histological and biochemical changes induced by stilbestrol and testosterone in the uterus of rats.

A comparative study on the effects of clomiphene on the stilbestrol- and testosterone-induced changes in the weight, histology and biochemical constituents of the uterus was undertaken. Clomiphene counteracted the stilbestrol-induced increase in the weight, and the absolute contents of the glycogen, protein and RNA of the uterus, possibly by competitive inhibition. It failed to prevent such changes induced by testosterone: on the contrary, there were some additive effects. The results of the present study indicate that the binding sites for the estrogen and the androgen in the uterus are different.

Animals↗
PubMed2000

Correction of hyperinsulinemia in oligoovulatory women with clomiphene-resistant polycystic ovary syndrome: a review of therapeutic rationale and reproductive outcomes.

Polycystic ovary syndrome (PCOS) describes a convergence of chronic multisystem endocrine derangements, including irregular menses, hirsutism, obesity, hyperlipidemia, androgenization, large and cystic-appearing ovaries, insulin resistance and subfertility. Few PCOS patients exhibit all of these features, and often only one sign or symptom is evident. The sequelae of PCOS reach beyond reproductive health, as women affected with PCOS have increased relative risks for myocardial infarction, hypertension, ischemic heart disease, thromboembolic disease and diabetes. Although the adverse health consequences associated with PCOS are substantial, unfortunately most women are not aware of these risks. Indeed, in infertility practice such concerns are secondary as most patients are referred for treatment specifically to achieve a pregnancy. Impairments in insulin metabolism appear central to the physiologic cascade of PCOS, yet clomiphene therapy fails to remedy this defect. Several investigators have described satisfactory reproductive outcomes for PCOS patients treated with oral insulin-lowering agents. In this report, we outline a diagnostic and therapeutic approach for women with PCOS refractory to clomiphene with attention to the underlying insulin imbalance associated with impaired fertility.

Clomiphene↗
PubMed2006

Clomiphene citrate challenge test predicts outcome of intrauterine insemination in women aged under 37 years.

The clomiphene citrate challenge test is a tool to predict ovarian reserve and fertility. It has mainly been used as a predictor of success of IVF/intracytoplasmic sperm injection (ICSI) cycles. Infertile young women with diminished ovarian reserve have a worse prognosis than women with adequate ovarian reserve attempting IVF/ICSI cycles. Nothing is known regarding the outcome of young women with diminished ovarian reserve undergoing low-complexity assisted reproductive treatment such as ovulation induction plus intrauterine insemination (IUI). This study included all women under 37 years who consulted in the authors' centre between May 2004 and August 2005 who underwent ovulation induction and IUI. Ninety-six women younger than 37 years with adequate ovarian reserve, and 50 women with diminished ovarian reserve were found. The pregnancy rate and pregnancy rate per cycle in the adequate ovarian reserve group were significantly higher than those of the diminished ovarian reserve group (46.7% versus 25%, P < 0.02 ; 15.9% versus 7.6%, P < 0.02 respectively). It is concluded that the clomiphene citrate challenge test is a good predictor of low-complexity infertility intervention outcome, and represents an effective tool to establish a prognosis. Therefore, it is very useful in planning therapy, and advising the infertile couple.

Adult↗
PubMed2003

Clomiphene citrate versus letrozole for ovarian stimulation: a pilot study.

The purpose of this pilot study was to compare the endocrinological environment of cycles stimulated with clomiphene citrate (CC) or letrozole. Fifteen patients undergoing intrauterine insemination (IUI) received from day 3 to day 7 of the cycle either letrozole 2.5 mg/day (n = 7) or clomiphene citrate 100 mg/day (n = 8). IUI was performed one day after the detection of LH peak. No luteal support was administered. Significantly lower serum oestradiol concentrations were present in the follicular phase on days 9, 13 and 15 of the cycle and in the luteal phase on days 3 and 6 post-IUI in the letrozole group compared with those in the CC group. Progesterone concentrations and oestradiol concentrations were significantly lower in the letrozole group than in the CC group on the day of LH peak. Significantly more follicles developed in patients in the CC group compared with those in the letrozole group. In conclusion, significantly lower oestradiol concentrations and fewer follicles are observed in cycles stimulated with 2.5 mg letrozole compared with cycles stimulated with 100 mg CC from day 3 to day 7 of the cycle.

Adult↗
PubMed2003

Single dose application of cetrorelix in combination with clomiphene for friendly IVF: results of a feasibility study.

A prospective randomized feasibility study was carried out on 10 patients undergoing IVF treatment using a single-dose LHRH antagonist protocol (cetrorelix, Cetrotide) with clomiphene citrate in combination with either human menopausal gonadotrophin (HMG) (n = 5) or recombinant human FSH (rFSH) (n = 5). Both treatment-groups, HMG and rFSH, were comparable with regard to age (33.2 +/- 2.6 versus 34.4 +/- 4.0 years) BMI (23.2 +/- 2.6 versus 22.7 +/- 1.6) and cause of infertility. They yielded comparable results concerning gonadotrophin dose (19.8 +/- 8.7 versus 17.0 +/- 8.9), stimulation days (6.5 +/- 2.0 versus 5.8 +/- 1.9) and live births (one versus two). No premature LH surge (LH >10 IU/ml and progesterone >1 ng/ml) occurred. The overall baby take-home rate was 30%. In a small number of patients, cetrorelix could be shown to effectively prevent premature LH surges in stimulation protocols combining clomiphene with gonadotrophins with an excellent baby take-home rate per started cycle of 30%.

Adult↗
PubMed1981

The relationship of the oestrogen and progestin receptors in the abnormal uterus of the adult anovulatory rat. Effects of neonatal treatment with testosterone propionate or clomiphene citrate.

The neonatal administration of testosterone propionate to Wistar rats resulted in anovulatory adults in persistent vaginal oestrus. Clomiphene citrate had a similar effect. In both groups of adults, hyperplasia of the uterine epithelium and occasional metaplasia was observed. The uterine nuclear and cytosol oestrogen and progestin receptors of these anovulatory rats were found to have affinities for their respective ligands similar to those of normal females. The nuclear oestrogen receptor comprised occupied and unoccupied components, as in normal females. The content of the nuclear oestrogen receptor was comparable with that of females in the late dioestrous or pro-oestrous phase. This content was higher in the clomiphene-treated group. Despite the relatively high nuclear oestrogen receptor content the content of progestin receptors, a putative index of the oestrogenic response, was lower in the treated rats than in normal adult females throughout the cycle. Administration of oestradiol to both treatment groups resulted in depletion of cytosol oestrogen receptor content 1 h later, which, however, was not reflected by an increase in the content of nuclear oestrogen receptors. There was no measurable increase in progesterone receptor content in treated rats after daily administration of oestrogen (5 microgram/rat) for 3 days. These changes in sex-hormone-receptor interactions involving an impairment of the normal oestrogenic response may be associated with the abnormal differentiation of the uterus in these sterile, anovulatory animals.

Animals↗
PubMed1979

[Treatment with clomiphene of endocrine primary and secondary infertility in women (author's transl)].

Clomiphene (Dyneric) in a daily dosage of 100--300 mg, partially combined with HCG (n = 12), was used in the treatment of 86 women aged 19 to 39 years with primary or secondary infertility of endocrine origin in 296 menstrual cycles. In 67 cases (77.9%) ovulation could be induced and in 38 cases (44.2%) pregnancy occurred. In addition, in 4 cases pregnancy occurred two months after cessation of treatment. Combination therapy with HCG was successful in some of the cases resistant to clomiphene.

Adult↗
PubMed2003

Characteristics of the best prognostic evidence: an example on prediction of outcome after clomiphene citrate induction of ovulation in normogonadotropic oligoamenorrheic infertility.

The standard first-line treatment for normogonadotropic anovulatory infertile patients [referred to as World Health Organization group 2 (WHO 2)] is ovulation induction using clomiphene citrate (CC) in incremental doses. Twenty to 25% of women show clomiphene-resistant anovulation (CRA), that is, they remain anovulatory even after multiple attempts with increased doses of CC. About 50% of the ovulatory CC patients conceive within six CC-induced cycles. Given the heterogeneous nature of the group, the individual prognosis (i.e., the chance of success) will vary considerably between patients. In the event an individual prognosis of each patient would be available before the start of the treatment, the overall efficiency of ovulation induction could be improved. Prognostic evidence at an individual level should use multiple patient variables, including results from previous treatments (if any). When variables are interdependent, a statistical model can be used to relate individual characteristics with the predicted outcome. Such a model will provide estimates of prognosis for individualized patient profiles, allowing new patients to profit from the experience of the cohort of previous patients used to build the model. This paper discusses the prediction of time to pregnancy following induction of ovulation with CC. This prediction was broken down in two steps, leading to two separate prognostic models. The first model predicts an intermediate outcome, the chance that the patient will be CRA (i.e., no ovulation in response to CC medication); the second model predicts the final outcome (time until pregnancy) in women who do ovulate. The CRA model was based on a prospective cohort study of 201 patients with normogonadotropic oligoamenorrheic infertility, 45 of whom were CRA (22%). It contained four predictor variables all related to the diagnosis of PCOS within the group of WHO 2: Increased free androgen index (FAI; hyperandrogenemia), elevated body mass index (BMI; obesity), greater mean ovarian volume (as an ultrasound feature of polycystic ovaries), and amenorrhea were all predictive for CRA. The second model was based on the non-CRA patients and contained two prognostic variables: increased age and oligomenorrhea were predictive for longer time to pregnancy after first ovulation with CC. Using the example of the prediction of time to pregnancy following induction of ovulation with CC, we present and discuss characteristics of good prognostic evidence for clinical use, focusing on study design, statistical analysis, evaluation, and presentation of results.

Amenorrhea↗
PubMed1991

Failure to induce ovulation with clomiphene citrate and bromocriptine in luteal deficient women athletes.

This study was designed with a three-fold aim: to assess ovarian function of women athletes with menstrual irregularities (AMI); to evaluate the potentiality of clomiphene citrate and bromocriptine for the induction of ovulation in these women; and to show that ultrasound scanning offers a suitable technique for ovarian screening in healthy and high-performance athletes. Our small test group consisted of 11 women, mainly track athletes, with AMI. There was no significant difference in age at menarche (13.2 yrs +/- 0.2), percent of ideal body weight (92% +/- 4), or percent of body fat (12.3% +/- 2.8) among the subjects. Plasma estradiol values were low (mean: 22 pg/ml +/- 0.8), as those of plasma progesterone (2.85 ng/ml +/- 2.10), LH (5.6 mIU/ml +/- 0.8), and prolactin (10.89 ng/ml +/- 5.56). The mean distance run per week (35 km +/- 15) was relatively high considering the presence of 4 non-runners. All menstrual irregularities were attributed to exercise. A short luteal phase (7 days +/- 1.5 for a cycle with a mean duration of 25 days +/- 1.8) was found in all subjects. We failed to observe the presence of a corpus luteum in 9 out of 11 women. A two-month administration of clomiphene citrate (150 mg/d for 5 days) or bromocriptine (2.5 mg/d) did not succeed in provoking ovulation in any of these women. Ultrasonographic observations showed a continuously hypo-estrogenic endometrium with a consecutively developing and regressive follicle. Our data emphasize the difficulties inherent in the restoration of menstrual function in women athletes with AMI. In addition, the usefulness of ultrasound in screening ovarian function was confirmed.

Adolescent↗
PubMed1990

[Dehydroepiandrosterone sulfate (DHEAS) concentration changes in clomiphene therapy?].

Plasma DHEAS levels were followed in 10 anovulatory patients, treated with 50 mg clomiphene citrate from the 5th to the 9th day of menstruation as well as 6 ovulatory women, who were taken as controls. A serum progesterone level of 13 nmol/l or more in the luteal phase was found in both, the treatment and the control group. This was considered to be a strong indication, that ovulation had occurred. A significant preovulatory increase in DHEAS levels was found neither in the treatment nor in the control group. A negative influence of DHEAS on the ripening of the follicles due to a single dose of 50 mg of clomiphene during 5 days of menstruation seems unlikely.

Adult↗
PubMed1980

[The serum levels of estradiol-17 beta and progesterone following hyper-stimulation of the ovaries by clomiphen].

The serum levels of estradiol-17 beta and progesterone in a cycle which was hyperstimulated by Clomiphen are reported. The pre-ovulatory maximum of estradiol-17-beta was 3,240 pg/ml, the maximum during the luteal phase was 2,930 pg/ml. The increase of progesterone to 54.8 ng/ml during the luteal phase was an indication of multiple ovulation. Bilateral ovarian enlargement was palpated. At the same dosage in the following menstrual cycle the maximum pre-ovulatory estradiol-17-beta was 962 pg/ml and the maximum progesterone in the luteal phase was 9.1 ng/ml. During this second cycle the ovaries were not palpably enlarged. It is concluded that sensitivity of the ovaries to hyper-stimulation by Clomiphen may vary from menstrual cycle to menstrual cycle. A single hyperstimulation does not necessarily indicate further hyperstimulation in subsequent cycles.

Adult↗