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PubMed2006

Determination by liquid chromatography-mass spectrometry of clomiphene isomers in the plasma of patients undergoing treatment for the induction of ovulation.

A rapid, sensitive and selective LC-MS method is described for the simultaneous determination of zuclomiphene and enclomiphene in plasma from patients undergoing treatment with clomiphene citrate for the induction of ovulation. Samples spiked with N-didesmethyltamoxifen, the internal standard, were extracted into methyl tertiary butyl ether. The compounds were separated on a Luna C(18) analytical column, and a mobile phase of methanol-water (70:30 v/v) containing 0.05% trifluoroacetic acid at a flow rate of 1ml/min. The limits of determination were 35pg/ml and 7pg/ml for zu- and enclomiphene, respectively. Within-day coefficients of variation ranged from 2.1% to 7.2%.

Chromatography, High Pressure Liquid↗
PubMed2006

Relative effects of estradiol-17beta (E2), catecholestrogens and clomiphene citrate on in vitro oocyte maturation in the catfish Heteropneustes fossilis (Bloch) and E2 inhibition of 2-hydroxyestradiol-induced maturation.

In vitro effects of estradiol-17beta (E(2)), the catecholestrogens 2-hydroxyE(2) (2-OHE(2)) and 2-methoxyE(2), and the nonsteroidal antiestrogen clomiphene citrate (clomid) on oocyte maturation were investigated in the catfish Heteropneustes fossilis. Incubation of postvitellogenic follicles with 2-OHE(2) induced germinal vesicle breakdown (GVBD; 86% at 5 microM for 30 h) and progression of meiosis up to metaphase II, as evident from the presence of Hoechst stained metaphase chromosomes and anti-alpha-tubulin-positive bipolar spindles. The response was both concentration (1, 2.5, 5, 10, and 20 microM)- and duration (0, 3, 6, 12, 24, and 30 h)-dependent. The diameter of the follicles increased and about 20% follicles elicited ovulation. Incubation of the follicles with clomid (20 microM) induced only about 29-35% GVBD at 30 h. This might be due to the dual properties of clomid with estrogenic (cis-isomer) and antiestrogenic (trans-isomer) actions or due to estrogen receptor binding dynamics. Incubations of the follicles with E(2) or 2-methoxyE(2) did not induce oocyte maturation. The higher concentrations of 2-methoxyE(2) caused degenerative changes in the follicles. In competition studies, E(2) inhibited the GVBD response of 2-OHE(2) (5 microM) significantly in a concentration (1, 5, 10, and 20 microM) or duration (2, 4, and 6 h)-dependent manner after pre-incubation with 20 microM E(2) (P<0.001, one-way ANOVA, P<0.05, Newman-Keuls' test). The results show that 2-OHE(2) induces maturational activity while the parent estrogen is a strong inhibitor, alone or in combination with 2-OHE(2).

2-Methoxyestradiol↗
PubMed1976

Effect of clomiphene citrate on serum prolactin in infertile women with ovarian dysfunction.

Serum prolactin (PRL) levels were determined by radioimmunoassay in 12 normal, menstruating women and in 26 infetile women with ovarian dysfunction for one cycle or for about 30 days in amenorrheic women. Galactorrhea was not observed. No significant change in serum PRL levels was observed throughout the normal, menstrual cycle. Of the 26 patients with ovarian dysfunction, seven showed PRL levels higher than normal. Twelve of the 26 patients were treated with clomiphene citrate (Clomid), 100 mg, daily for 5 days. Ovulation occurred in seven, and pregnancy was achi-ved in two of them. Serum PR;, follicle-stimulating hormone, and luteinizing hormone were measured for a preceding control cycle and during the cycle following Clomid treatment in the 12 patients. The serum PRL levels were normal during the control cycle in five of the patients who ovulated with Clomid and high in four patients who failed to ovulate. Although serum PRL levels were not significantly changed by Clomid in the patients who ovulated with the drug, they were markedly decreased during and immediately after Clomid treatment in patients who failed to ovulate with Clomid.

Clomiphene↗
PubMed2000

A randomized controlled study comparing the endocrine effects of pulsatile intravenous gonadotropin-releasing hormone after gonadotropin-releasing hormone agonist pretreatment versus clomiphene citrate in patients with polycystic ovary syndrome.

OBJECTIVE: To compare the endocrine changes in the follicular phase in infertile patients with polycystic ovary syndrome (PCOS) treated with either pulsatile IV GnRH after GnRH-agonist (GnRH-a) down-regulation or clomiphene citrate (CC). DESIGN: Subgroup analysis within a randomized, controlled, multicenter study. SETTING: Women referred to the Infertility Clinic, Catharina Hospital Eindhoven, The Netherlands. PATIENT(S): Twenty-eight infertile patients with PCOS. INTERVENTIONs): Patients were randomly assigned to pulsatile IV GnRH (10-20 microgram/90 min) after GnRH-a down-regulation or CC (50-150 mg; cycle days 3-7). Patients were monitored on alternate days with ovarian sonography and serum concentrations of E(2), LH, and FSH. Serum P and sonography confirmed ovulation. MAIN OUTCOME MEASURE(S): Serum concentrations of E(2), LH, and FSH were assessed before treatment was started and after each ovarian sonography. RESULT(S): In ovulatory cycles, no statistically significant differences were observed during the follicular phase comparing serum concentrations of E(2), LH, and FSH between the treatments. However, a significant increase in LH occurred in the GnRH group. CONCLUSION(S): No significant endocrine differences were observed between GnRH and CC treatment. However, there was a significant increase in the serum LH concentration during the follicular phase in the GnRH group. Increments of LH in the GnRH group may be due to recovery of endogenous LH secretion.

Adult↗
PubMed2001

A prospective randomized trial comparing clomiphene citrate with tamoxifen citrate for ovulation induction.

OBJECTIVE: To compare the rates of ovulation and pregnancy after tamoxifen citrate (TMX) or clomiphene citrate (CC) among anovulatory women with infertility. DESIGN: Prospective randomized trial. SETTING: Infertility clinic in a university teaching hospital. PATIENT(S): Eighty-six anovulatory women under 40 years of age undergoing ovulation induction. INTERVENTION(S): The women were assigned randomly to receive either TMX or CC on cycle days 5-9. MAIN OUTCOME MEASURE(S): Rates of ovulation and pregnancy for the two treatment modalities. RESULTS(S): The overall rate of ovulation in the TMX group was 50 of 113 (44.2%) and in the CC group, 41 of 91 (45.1%). There were 10 pregnancies in the TMX group and 6 pregnancies in the CC group. The cycle fecundity per ovulatory cycle was 20.0% in the TMX group and 14.6% in the CC group. CONCLUSION(S): The overall rate of ovulation and pregnancy were similar with TMX and CC. TMX is a suitable alternative agent to CC in the management of anovulatory infertility.

Adult↗
PubMed2002

A nomogram to predict the probability of live birth after clomiphene citrate induction of ovulation in normogonadotropic oligoamenorrheic infertility.

OBJECTIVE: To establish whether initial screening characteristics of normogonadotropic anovulatory infertile women can aid in predicting live birth after induction of ovulation with clomiphene citrate (CC). DESIGN: Prospective longitudinal single-center study. SETTING: Specialist academic fertility unit. PATIENT(S): Two hundred fifty-nine couples with a history of infertility, oligoamenorrhea, and normal follicle-stimulating hormone (FSH) concentrations who have not been previously treated with any ovulation-induction medication. INTERVENTION(S): 50, 100, or 150 mg of oral CC per day, for 5 subsequent days per cycle. MAIN OUTCOME MEASURE(S): Conception leading to live birth after CC administration. RESULT(S): After receiving CC, 98 (38%) women conceived, leading to live birth. The cumulative live birth rate within 12 months was 42% for the total study population and 56% for the ovulatory women who had received CC. Factors predicting the chances for live birth included free androgen index (testosterone/sex hormone-binding globulin ratio), body mass index, cycle history (oligomenorrhea versus amenorrhea), and the woman's age. CONCLUSION(S): It is possible to predict the individual chances of live birth after CC administration using two distinct prediction models combined in a nomogram. Applying this nomogram in the clinic may be a step forward in optimizing the decision-making process in the treatment of normogonadotropic anovulatory infertility. Alternative first line of treatment options could be considered for some women who have limited chances for success.

Abortion, Spontaneous↗
PubMed2002

Comparison of stimulation with clomiphene citrate in combination with recombinant follicle-stimulating hormone and recombinant luteinizing hormone to stimulation with a gonadotropin-releasing hormone agonist protocol: a prospective, randomized study.

OBJECTIVE: To compare IVF-ET outcome with a new stimulation protocol using clomiphene citrate (CC) with recombinant FSH and LH to stimulation with the standard long GnRH-a protocol. DESIGN: Prospective randomized study. SETTING: Outpatient infertility clinic in Vienna, Austria. PATIENT(S): Two hundred ninety-four infertile women undergoing IVF-ET; 154 IVF cycles stimulated with CC + recombinant FSH + recombinant LH (group A) and 140 cycles with long GnRH-a suppression + recombinant FSH (group B). INTERVENTION(S): Controlled ovarian hyperstimulation, egg retrieval, and ET. MAIN OUTCOME MEASURE(S): Cycle parameters (number of oocytes, fertilization, number of embryos) and outcome (pregnancy rate, cancellation rate, ovarian hyperstimulation syndrome [OHSS]). RESULT(S): Pregnancy rate per ET was 42.9% (implantation rate, 21.3%) in group A and 36.6% (17.4%) in group B. Cancellation rates were similar. The OHSS occurred in four cases (3%) in group A and 12 cases (10%) in group B. CONCLUSION(S): Stimulation with CC + recombinant FSH + recombinant LH leads to comparable pregnancy rates vs. the long protocol. With this new stimulation, less gonadotropins are used and there is less need for monitoring (lower cost for patient and clinic). The risk of OHSS is reduced as well. Therefore, this protocol should be regarded as the first-line treatment.

Adult↗
PubMed2002

Effects of initiation day of clomiphene citrate on the endometrium of women with regular menstrual cycles.

OBJECTIVE: To investigate the effects of initiation time of clomiphene citrate (CC) on the endometrium of women with regular menstrual cycles. DESIGN: Randomized, double-blind, cross-over study. SETTING: Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand. PATIENT(S): Thirty-three healthy female volunteers with regular menstrual cycles. INTERVENTION(S): The volunteers were randomized to receive either 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). After a wash-out period of 1 month of CC treatment, the medication was switched in each group. Ultrasonography was performed daily after day 10 of the cycle to detect ovulation. Ultrasonography for endometrial appearance and thickness, endometrial sampling, and blood samples obtained for determination of E(2) and P levels were performed 7 days after ovulation in both groups. MAIN OUTCOME MEASURE(S): Morphometric analysis, histologic dating, and ultrasonographic appearance and thickness of the endometrium. RESULT(S): Morphometric parameters, histologic dating, and ultrasonographic appearance and thickness of the endometrium were similar in both groups. CONCLUSION(S): Starting CC on either day 1 or day 5 of the menstrual cycle did not have any differential effects on the endometrium of women with regular menstrual cycles, particularly regarding the morphometric analysis, histologic dating, or ultrasonographic appearance.

Adult↗
PubMed2003

Live birth of healthy twins after a heterotopic tubal and intrauterine twin pregnancy in a woman who was stimulated with clomiphene citrate.

OBJECTIVE: To report a heterotopic pregnancy with successful delivery of monochorionic-diamniotic twins after rupture of the tubal ectopic gestation. DESIGN: Case report. University teaching hospital. PATIENT(S): A patient with heterotopic twin monochorionic-diamniotic pregnancy. INTERVENTION(S): Surgical removal of the ectopic pregnancy. MAIN OUTCOME MEASURE(S): Pregnancy course and outcome. The patient successfully delivered twins. CONCLUSION(S): Heterotopic pregnancy after clomiphene citrate administration may have a complicated course, but could end in successful live birth of twins.

Adult↗
PubMed1979

Induction of ovulation in women with hyperprolactinemic amenorrhea using clomiphene and human chorionic gonadotropin of bromocriptine.

Clomiphene citrate (Clomid), when given alone, is generally considered ineffective in inducing ovulation in women with hyperprolactinemia. This study reports the treatment of 29 infertile women with hyperprolactinemic amenorrhea. Twenty-one patients (eighteen of whom had previously had no ovulation response to Clomid alone) were treated with a combined regimen of Clomid (100 to 200 mg/day for 5 days) and two injections of 5000 IU of human chorionic gonadotropin (HCG), the first 8 to 10 days after Clomid withdrawal and a second injection 1 week later. Basal body temperature charts, conception, and/or plasma progesterone measurements showed that 19 patients ovulated (90%). There were 17 pregnancies in 12 of 21 patients (57% pregnancy rate) with 15 single live births and two abortions. When bromocriptine (Parlodel) became available, a total of 22 patients (including 14 patients previously treated with Clomid/HCG, six of them successfully) with amenorrhea associated with hyperprolactinemia were treated with this drug with dosages varying from 2.5 mg to 15 mg/day. Ovulation was confirmed in 20 patients (90%). There were 17 pregnancies in 15 patients (68% pregnancy rate) with 15 single live births and two first-trimester abortions. In all, 21 of 29 patients (73%) achieved one or more pregnancies resulting in live births with one or both of the above treatments. It is concluded that a combined Clomid/HCG regimen can often be used as an effective alternative to bromocriptine therapy in the treatment of infertility associated with hyperprolactinemic amenorrhea.

Adult↗
PubMed1979

Clomiphene therapy in male infertility: a negative report.

The enthusiastic acceptance of the use of clomiphene citrate in the treatment of the subfertile male prompts the issuance of this report. Fifty-four subfertile males were treated following recommended guidelines. In addition, testicular biopsy was performed in each patient. Analysis of the results, even excluding those with elevated follicle-stimulating hormone levels (which everyone concedes spells a poor prognosis), shows only a small percentage of improvement.

Adult↗
PubMed1980

Effect of clomiphene citrate on corticosteroid-binding globulin and serum progesterone levels during ovulation induction.

Mid-luteal phase serum progesterone, cortisol, and corticosteroid-binding globulin concentrations were measured in 46 conception cycles and in 19 ovulatory, non-conception cycles in patients with spontaneous ovulation and following ovulation induction with clomiphene citrate (Clomid) or human menopausal gonadotropin. Significant elevations (P less than 0.05) of serum corticosteroid-binding globulin were noted in patients under therapy with Clomid. This effect was not secondary to elevated serum estrogen levels. This alteration in serum binding protein levels appears to be secondary to a direct effect of Clomid on hepatic synthesis and may have significance in relation to progesterone binding and metabolism during ovulation induction with Clomid.

Adrenal Cortex Hormones↗
PubMed1982

A life-table analysis of pregnancy yield in fixed low-dose menotropin therapy for patients in whom clomiphene citrate failed to induce ovulation.

Forty-nine patients in whom clomiphene citrate failed to induce ovulation were treated for 177 cycles with a fixed low dosage of menotropin. Among these 49 patients, there were 24 pregnancies. Among these pregnancies were two that were multiple and three spontaneous abortions. In only one treatment cycle was there a hyperstimulation syndrome. These patients were divided into three clinical groups: the secondary amenorrheic patient, the oligo-amenorrheic patient, and the patient with poor corpus luteum function. There was no statistically significant difference in the pregnancy rate per month among all groups during the first three treatment cycles (average value, 0.07). However, there was a statistically significant improvement in the pregnancy rate per month in the group with secondary amenorrhea and the group with poor corpus luteum in the last three treatment cycles, as compared with the first three treatment cycles (P = 0.05; average value, 0.75). The oligo-amenorrheic patients, on the other hand, during the last 3 months of treatment, had no statistically significant increase in the pregnancy rate per month. These data suggest that menotropin therapy may have a priming effect. These data do not fit the currently accepted model of a constant pregnancy rate per month for all patients. The data suggest that caution should be exercised before combining patient groups when evaluating the results of menotropin therapy.

Amenorrhea↗
PubMed1983

Sequential clomiphene citrate-menotropin therapy for induction or enhancement of ovulation.

Either to induce ovulation in anovulatory infertility patients or to enhance ovulation in patients with mild endometriosis or luteal phase inadequacy, we utilized a sequential regimen of low-dose clomiphene citrate (CC) followed by human menopausal gonadotropin (hMG) injections on alternate days; duration and dosage of menotropin therapy was individualized by using serum estradiol levels for monitoring until the time of administration of human chorionic gonadotropins. Previous therapeutic efforts without menotropins had been unsuccessful in all patients. One third of 70 treated patients conceived during 156 treatment cycles. The pregnancy rate was 44% in anovulatory patients (n = 34), and 26% in patients with ovulation dysfunction (n = 23). Pregnancy rates declined with patient's age. Four of the 23 patients that conceived had a spontaneous abortion (17%). The multiple gestation rate was 10.5%. A relative inhibition of cervical mucus development was noted and shown to be caused by CC. Hyperstimulation occurred in three patients. The discussed CC-hMG regimen approaches the effectiveness of standard hMG therapy; but compared with standard hMG therapy, it has significant economic advantages and seems to have a markedly lower rate of multiple gestation. However, like standard hMG therapy, CC-hMG therapy requires careful monitoring specifically, because hyperstimulation may occur.

Adult↗
PubMed1983

Comparison of two clomiphene citrate dosage regimens for follicular recruitment in an in vitro fertilization program.

Clomiphene citrate (CC) (150 mg/day) is used in most clinical in vitro fertilization and embryo transfer (IVF-ET) programs to induce maturation of several preovulatory follicles rather than the one characteristic of the unstimulated cycle. This study examines whether a reduced dosage of CC will induce the maturation of a similar number of follicles. The advantage of the reduced dosage should be a decrease in the dose-dependent antiestrogenic effects of CC. Normally ovulating women undergoing treatment in an IVF-ET program received CC on cycle days 5 to 9. Thirty-six patients received 150 mg/day, and 60 patients received 50 mg/day. There were no significant differences between the groups in the number or the size of follicles as measured by ultrasonography on the day of human chorionic gonadotropin administration. All seven clinical pregnancies were in the 50 mg group (P less than 0.05). These data suggest that there is no advantage to the 150 mg/day dosage of CC as compared with 50 mg/day with respect to enhanced follicular recruitment, and the higher dosage may have a detrimental effect on pregnancy establishment.

Chorionic Gonadotropin↗
PubMed1983

Congenital malformations of newborn infants after clomiphene-induced ovulation.

The effect of clomiphene citrate (CC) on the incidence of congenital malformations in newborn infants was assessed from the outcome of 1034 pregnancies after CC-induced ovulation recorded at nine university hospitals in a 5-year period. Of these pregnancies, 14.2% ended in abortion, 0.5% in ectopic pregnancy, 0.1% in molar pregnancy, and 1.6% in stillbirth. In all, 935 infants were born, and 21 (2.3%) showed visible malformations. This incidence of malformations was not significantly different from that in 30,033 infants (1.7%) after spontaneous ovulation (spontaneous ovulation group), and the types of malformations after CC treatment were similar to e those in the spontaneous ovulation group. These data indicate that CC has no teratogenic effect.

Abnormalities, Drug-Induced↗