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PubMed2004

[The use of clomiphene citrate in ambulatory medicine practice in the Midi-Pyrénées area: compliance to national guidelines applicable to infertility diagnosis and to prescription and monitoring rules applicable to clomiphene citrate treatments].

OBJECTIVE: Evaluate the compliance to the national guidelines from ANDEM (1996) and AFSSAPS (2003) concerning the diagnosis of infertility, the prescription of clomiphene and the monitoring of these treatments. PATIENTS AND METHODS: Retrospective study of female patients from 16 to 50 y.o. having benefited from reimbursement of clomiphene citrate treatment between 1st April 2002 and 30th June 2002. After random sampling stratified on age, data on diagnosis procedures and treatments were extracted from the Social Security reimbursement database. These data were validated and completed by patients' interviews. RESULTS: A total of 283 women were included. 30% were subject to the basic hormonal tests (FSH, LH, estradiol). The proportion of patients explored by hysterosalpingogram, post-coital test and echography were respectively 50%, 35% and 68%. A semen analysis was found in 60% of the partners. The complete set of recommended tests before start of treatment was realised in 1.5% of women. In 7% of cases, women were treated without prior exploration. The proportion of tests performed was comparable below and above the age of 35. 77% of treatments were initiated after at least one year of waiting for a spontaneous conception. 69% of women were monitored during treatment by other methods than clinical follow-up. CONCLUSION: Prescription of clomifene citrate is too frequently realised without compliance to guidelines applicable to infertility investigations and therefore without persuasive diagnosis. These practices can lead to loss of childbearing opportunities and complications.

Adult↗

PubMed2006

Clomiphene citrate and dexamethazone in treatment of clomiphene citrate-resistant polycystic ovary syndrome: a prospective placebo-controlled study.

BACKGROUND: The aim of this work was to evaluate the efficacy of adding dexamethazone (DEX) (high dose, short course) to clomiphene citrate (CC) in CC-resistant polycystic ovary syndrome (PCOS) with normal dehydroepiandrosterone sulphate (DHEAS) in induction of ovulation. METHODS: Eighty infertile women with CC-resistant PCOS were randomly assigned into two groups. Group I: Clomiphene citrate 100 mg/day was given from day 3 to day 7 of the cycle and DEX 2 mg/day from day 3 to day 12 of the cycle. Group II: Same protocol of CC combined with placebo (folic acid tablets) was given from day 3 to day 12 of the cycle. The main outcome was ovulation. Secondary measures included number of follicles >18 mm endometrial thickness and pregnancy rate. Ovarian follicular response was monitored by transvaginal ultrasound. HCG 10,000 U was given when at least one follicle measured 18 mm, and timed intercourse was advised. RESULTS: There were no statistically significant differences between groups as regards age, duration of infertility, BMI, waist-hip ratio (WHR), menstrual pattern, hirsutism, serum DHEAS or day of HCG administration. The mean number of follicles>18 mm at the time of HCG administration and the mean endometrial thickness were significantly higher in the DEX group than in the placebo group (P<0.05). Similarly, there were significantly higher rates of ovulation (75 versus 15%) (P<0.001) and pregnancy (40 versus 5%) (P<0.05) in the DEX group. Dexamethazone was very well tolerated as no patients complained of any side effect. There was a significant difference between the responders and non-responders in the presence of oligomenorrhea, amenorrhea or hirsutism. CONCLUSION: Induction of ovulation by adding DEX (high dose, short course) to CC in CC-resistant PCOS with normal DHEAS is associated with no adverse anti-estrogenic effect on the endometrium and higher ovulation and pregnancy rates in a significant number of patients. Induction with DEX appears to be independent on age, period of infertility, BMI or WHR.

Adult↗

PubMed1981

Induction of ovulation by combined clomiphene citrate and dexamethasone treatment in clomiphene citrate nonresponders.

Fifteen anovulatory, oligomenorrheic, hyperandrogenic and normoprolactinemic women who failed to respond to prolonged clomiphene citrate (CC) treatment, were subsequently treated with CC and small doses of dexamethasone (Dex). Twelve (80%) of the patients ovulated according to BBT and progesterone values, and 7 (49%) conceived during 3--6 treatment cycles. Five of these pregnancies terminated in live, single, full term deliveries, one set of twins and one first trimester abortion. It is concluded that a regimen of combined CC and a small dose of Dex may be offered to CC nonresponders as an effective alternative to Menotropins--HCG treatment.

Adult↗

PubMed2005

N-acetyl-cysteine is a novel adjuvant to clomiphene citrate in clomiphene citrate-resistant patients with polycystic ovary syndrome.

OBJECTIVE: To evaluate the effect of N-acetyl-cysteine (NAC), a mucolytic drug with insulin sensitizing properties, as an adjuvant therapy in subjects with polycystic ovary syndrome (PCOS) resistant to clomiphene citrate (CC). DESIGN: Placebo-controlled, double-blind randomized trial. SETTING: University-based hospital and private infertility practice. PATIENT(S): One hundred fifty women diagnosed with CC-resistant PCOS, aged 18-39 years undergoing therapy for infertility were included. INTERVENTION(S): The patients were assigned randomly to receive either NAC 1.2 g/d (group I) or placebo (group II) with CC 100 mg/d for 5 days starting at day 3 of the cycle. MAIN OUTCOME MEASURE(S): Ovulation rate and pregnancy rate (PR). RESULT(S): Combination of CC and NAC significantly increased both ovulation rate and PR in women with CC-resistant PCOS (49.3% vs. 1.3% and 21.3% vs. 0%, respectively). No cases of ovarian hyperstimulation syndrome (OHSS) were reported in the NAC group; two cases of miscarriage (12.5%) were reported. CONCLUSION(S): The NAC as an adjuvant to CC was more effective than placebo for CC-resistant patients with PCOS. It is safe and well tolerated.

Acetylcysteine↗

PubMed2001

Metformin increases the ovulatory rate and pregnancy rate from clomiphene citrate in patients with polycystic ovary syndrome who are resistant to clomiphene citrate alone.

OBJECTIVE: To determine whether metformin treatment increases the ovulation and pregnancy rates in response to clomiphene citrate (CC) in women who are resistant to CC alone. DESIGN: Randomized, double-blind, placebo-controlled trial. SETTING: Multicenter environment. PATIENT(S): Anovulatory women with the polycystic ovary syndrome (PCOS) who were resistant to CC. INTERVENTION(S): Participants received placebo or metformin, 500 mg three times daily, for 7 weeks. Information on reproductive steroids, gonadotropins, and oral glucose tolerance testing was obtained at baseline and after treatment. Metformin or placebo was continued and CC treatment was begun at 50 mg daily for 5 days. Serum P level > or =4 ng/mL was considered to indicate ovulation. With ovulation, the daily CC dose was not changed, but with anovulation it was increased by 50 mg for the next cycle. Patients completed the study when they had had six ovulatory cycles, became pregnant, or experienced anovulation while receiving 150 mg of CC. MAIN OUTCOME MEASURE(S): Ovulation and pregnancy rates. RESULT(S): In the metformin and placebo groups, 9 of 12 participants (75%) and 4 of 15 participants (27%) ovulated, and 6 of 11 participants (55%) and 1 of 14 participants (7%) conceived, respectively. Comparisons between the groups were significant. CONCLUSION(S): In anovulatory women with PCOS who are resistant to CC, metformin use significantly increased the ovulation rate and pregnancy rate from CC treatment.

Adolescent↗

PubMed2002

Use of dexamethasone and clomiphene citrate in the treatment of clomiphene citrate-resistant patients with polycystic ovary syndrome and normal dehydroepiandrosterone sulfate levels: a prospective, double-blind, placebo-controlled trial.

OBJECTIVE: To evaluate the effects of short-course administration of dexamethasone (DEX) combined with clomiphene citrate (CC) in CC-resistant patients with polycystic ovary syndrome (PCOS) and normal DHEAS levels. DESIGN: Prospective, double-blind, placebo-controlled, randomized study. SETTING: Referral university hospitals. PATIENT(S): Two hundred thirty women with PCOS and normal DHEAS who failed to ovulate after a routine protocol of CC. INTERVENTION(S): The treatment group received 200 mg of CC from day 5 to day 9 and 2 mg of DEX from day 5 to day 14 of the menstrual cycle. The control group received the same protocol of CC combined with placebo. MAIN OUTCOME MEASURE(S): Follicular development, hormonal status, ovulation rate, pregnancy rate. RESULT(S): Mean follicular diameters were 18.4124 +/- 2.4314 mm and 13.8585 +/- 2.0722 mm for the treatment and control groups, respectively. Eighty-eight percent of the treatment group and 20% of the control group had evidence of ovulation. The difference in the cumulative pregnancy rate in the treatment and control groups was statistically significant. CONCLUSION(S): Hormonal levels, follicular development, and cumulative pregnancy rates improved with the addition of DEX to CC in CC-resistant patients with PCOS and normal DHEAS. This regimen is recommended before any gonadotropin therapy or surgical intervention.

Adult↗

PubMed1986

Comparison of human menopausal gonadotropin, clomiphene citrate, and combined human menopausal gonadotropin-clomiphene citrate stimulation protocols for in vitro fertilization.

Human menopausal gonadotropins (hMG) and clomiphene citrate (CC), either alone or in combination, are frequently used for in vitro fertilization (IVF) in an attempt to maximize the number of oocytes recovered and the number of embryos transferred. However, direct comparison of the relative efficacy of these protocols in the same institution has been limited. To evaluate this question, the authors examined the outcome of 304 consecutive women attempting IVF. One hundred eighty-one women received hMG, 42 received CC, and 81 received combination hMG/CC. The percentages of women undergoing laparoscopy were not different among the groups (69%, 71%, and 74%, respectively), nor were the rates of oocyte recovery (94%, 100%, and 100%). However, the percentage of women achieving oocyte fertilization (77%, 83%, and 93%) and embryo transfer (73%, 83%, and 90%) were significantly greater among those who had received hMG/CC stimulation. A comparison of hMG/CC with hMG and CC cycles revealed a statistically significant increase in the total number of developing follicles (4.5 +/- 0.3, 3.3 +/- 0.2, and 3.1 +/- 0.3, respectively; P = 0.0137), total oocytes recovered (4.1 +/- 0.3, 3.2 +/- 0.2, and 2.5 +/- 0.2; P = 0.0011), and embryos transferred (2.2 +/- 0.2, 1.4 +/- 0.2, and 1.4 +/- 0.2; P = 0.0013). However, there was no significant difference in the occurrence of ongoing pregnancies. Thus, in terms of the per-patient number of follicles, oocytes, and embryo transfers, combined hMG/CC stimulation appears to be superior to either hMG or CC alone. However, to date the combined regimen has not improved pregnancy rates.

Clomiphene↗

PubMed1996

Menotropins alone are superior to a clomiphene citrate and menotropin combination for superovulation induction among clomiphene citrate failures.

OBJECTIVE: To examine the difference in efficacy between two protocols of superovulation induction with IUI among infertile couples. DESIGN: A prospective randomized trial. SETTING: Normal human volunteers in an infertility clinic. PATIENTS: Consecutively treated patients attending our infertility clinic for superovulation induction with IUI who had been unsuccessfully treated by clomiphene citrate (CC). INTERVENTIONS: Infertile couples were randomized to undergo one of two controlled ovarian hyperstimulation protocols. Group A patients received daily hMG beginning on cycle day 3, whereas group B patients were administered CC days 3 through 7, followed by hMG from day 7 onward. Randomization was performed using a random numbers table. In both groups, ovulation was triggered by 5,000 IU hCG and IUI was performed by 36 hours. MAIN OUTCOME MEASURES: Studied cycle performance parameters included peak E2, number of dominant and intermediate-sized follicles recruited, endometrial thickness and pattern, and frequency of monitoring. RESULTS: Data analysis demonstrated no significant difference between the two groups with respect to patient age, parity, weight, indication for superovulation and IUI, number of dominant follicles recruited, peak E2, or mean number of total motile sperm inseminated. Endometrial thickness and pattern differed between treatments, however, with group A demonstrating relatively thicker and proportionately more trilaminar patterns than group B. Group A had significantly more serum E2 measurements, as well as transvaginal sonograms performed, when compared with group B. Pregnancy rates for groups A and B were 0.192 and 0.091, respectively. Of 25 pregnancies in group A, 7 (0.28) were multiples, whereas there were no multiple gestations in group B. CONCLUSION: For patients undergoing superovulation with IUI, a menotropin-alone protocol yields significantly higher pregnancy rates than one using a combination of menotropin with CC. These differences could not be explained by patient characteristics. Among cycle performance parameters, endometrial thickness and pattern differed significantly between the two groups.

Adult↗

PubMed1999

Ovarian stromal echogenicity in women with clomiphene citrate-sensitive and clomiphene citrate-resistant polycystic ovary syndrome.

OBJECTIVE: To compare stromal echogenicity in women with clomiphene citrate (CC)-sensitive and CC-resistant polycystic ovary syndrome (PCOS), and to compare stromal echogenicity before and after laparoscopic ovarian drilling in women with CC-resistant PCOS. DESIGN: Prospective study. SETTING: University teaching hospital. PATIENT(S): Twenty-two infertile women. INTERVENTION(S): Transvaginal ultrasound examination and laparoscopic ovarian drilling. MAIN OUTCOME MEASURE(S): Ovarian stromal index (ratio of mean ovarian stromal echogenicity to mean echogenicity of the entire ovary). RESULT(S): The mean (+/- SD) ovarian stromal index was 1.26+/-0.27 in the women with CC-sensitive PCOS and 1.22+/-0.11 in the women with CC-resistant PCOS. The ovarian stromal index and ovarian volume of the women with CC-resistant PCOS before and after ovarian drilling were not significantly different. CONCLUSION(S): There was no difference in the stromal index and ovarian volume between women with CC-sensitive PCOS and women with CC-resistant PCOS. There was no overall difference in the stromal index and ovarian volume in women with CC-resistant PCOS before and after ovarian drilling.

Adult↗

PubMed2000

[Clomiphene acetate and prednisone: alternative approach for the management of patients with chronic anovulation and clomiphene treatment failure].

Chronic anovulation is a common neuroendocrine cause of infertility. Pharmacological management of such condition includes the use of clomiphen citrate (CC), which is the most utilized of the ovulation inductors. Clinical efficacy of CC provides ovulation rates of around 70%. Those patients who did not respond are candidates to receive gonadothrophin treatment, which will increase costs and the risk of ovarian hyperstimulation and multiple pregnancies. Because of that, new alternative treatments have been assayed, such as the concomitant use of dexametasone. This alternative has improved the response, but its use has been limited because the side effects of this treatment overcome their benefits. Another alternative is the use of prednisone throughout the menstrual cycle together with CC administered in pre-established days. This treatment is expected to improve the response without adding side effects. However, its clinical efficacy and clínical tolerance have not been studied. In this study we used CC and prednisone in a sample of patients diagnosed with infertility and chronic anovulation, and with previous failure to the treatment with CC. Patients were compared to a group of women with similar characteristics but who received additional cycles of CC. The group that received prednisone and CC increased their ovulation rates in 38%, compared to 8% in women that received only CC. Similarly, pregnancy rates increased 20% in the CC plus prednisone group while the group that received CC alone remained in 0 pregnancies. In the total sample, tolerance to treatment was adequate. There were no side effects associated to the use of prednisone. We conclude that the treatment with CC plus prednisone is an alternative treatment for patients in which the classical treatment with CC has failed.

Adult↗

PubMed1988

[Combined therapy with bromocriptine, clomiphene and gonadotropin for polycystic ovary syndrome patients failing to respond to clomiphene alone].

The purpose of this study is to investigate the ovulatory effect of the combined therapy with bromocriptine (Brc), clomiphene (Cl) and HMG. We investigated 25 patients with polycystic ovary syndrome (PCOS) who had anovulatory normoprolactinemia and failed to respond to Cl therapy alone. The results were as follows: 1) The ovulation rate with Method I(Brc/Cl) was 64.0% (16/25) in 25 cases, and 59.8% in 122 cycles. 2) Resting levels of serum dehydroepiandrosterone sulfate in the effective group with Method I were significantly lower than those in the non-effective group. 3) With Method I, serum prolactin (PRL), LH and testosterone were significantly decreased, while estradiol and progesterone concentrations were significantly increased in the effective group. However, there were no significant changes in the hormone levels except PRL in the non-effective group. 4) Out of the 9 nonrespondent Method I cases, 5 additional cases ovulated with both Method II(Brc/Cl+ a small dose of HMG) and Method III(Brc/Cl+ an increased dose of HMG-HCG). The total ovulatory rate was 84.0% (21/25) in 25 cases and 59.4% (85/143) in 143 cycles. 5) The total pregnancy rate was 43.8% (7/16). Six cases were normal pregnancies, one case was a twin pregnancy and there was no case of abortion. Our results suggested that the combined therapy with Brc, Cl and HMG had almost the same therapeutic effect as the HMG-HCG therapy in severe cases of PCOS.

Adolescent↗

PubMed1987

[Combined therapy of bromocriptine, clomiphene citrate and HMG in normoprolactinemic amenorrhea patients who fail to respond to bromocriptine-clomiphene citrate therapy].

The purpose of this study is to investigate the ovulatory effect of the following three methods on 40 patients with normoprolactinemic amenorrhea patients who failed to respond to clomiphene citrate (Cl) alone. Method I is the combined therapy with bromocriptine and Cl (Brc/Cl). Method II is the combined therapy with Brc/Cl and an additional small amount of HMG (less than or equal to 300 IU). Method III is the combined therapy with Brc/Cl and an increased amount of HMG (less than or equal to 1,200 IU) and HCG. The ovulation rate of method I was 57.5% (23/40) in 40 cases, and 55.6% (99/178) in 178 cycles. The pregnancy rate for this method was 23.8% (5/21). Out of the 12 nonrespondent method I cases, 5 additional cases were ovulated by method II and 3 cases were ovulated by method III. The total pregnancy rate was 42.9% (9/21) with these three methods. Seven cases were normal pregnancies, one case was a twin pregnancy and 1 case was an abortion. No other side effects were found in this study. From these results, the combined therapy with Brc/Cl or Brc/Cl + HMG had almost the same ovulatory rate as the HMG-HCG therapy, and fewer side effects.

Adolescent↗

PubMed1986

[The combined effect of bromocriptine and clomiphene citrate on normoprolactinemic anovulation; the lack of effectiveness of clomiphene citrate treatment alone].

The purpose of this study is to investigate the combined effect of bromocriptine and clomiphene citrate (Cl) treatment on 35 patients with normoprolactinemic amenorrhea who failed to respond to Cl alone. Ovulation was restored by this treatment in 20 of these patients (57.1%), and the pregnancy rate was 26.7%. This treatment was effective in 11 of 15 women with polycystic ovary like syndrome (73.3%). Resting levels of prolactin, estradiol and testosterone in the effective group were significantly higher than those in the non-effective group. As a result of the treatment, the prolactin and LH levels were significantly decreased, and estradiol and progesterone levels were significantly increased in the effective group. Before the treatment, the responsiveness of LH to LHRH in the effective group was significantly higher, but the responsiveness of prolactin to TRH in this group was not significantly higher than that in the non-effective group. After the treatment, the LH-releasing response following a premarin injection in the effective group was significantly higher than that in the non-effective group. The present results indicate that the therapeutic effect of this treatment may be primarily due to the restoration and improvement of the impaired hypothalamo-pituitary system without the suppression of pituitary prolactin secretion.

Adolescent↗

PubMed1993

Comparative trial of clomiphene citrate/human menopausal gonadotropin and the contraceptive pill, followed by clomiphene citrate/human menopausal gonadotropin, in a gamete intrafallopian transfer program.

PURPOSE: It may sometimes be necessary to regulate cycles in assisted reproduction. Cycles can be regulated with gonadotropin releasing hormone (GnRHa) agonist but other methods can also be used. The aim of this study was to compare the pregnancy rate in a gamete intrafallopian transfer (GIFT) program in patients receiving a contraceptive pill/Clomid/human menopausal gonadotropin (hMG) regimen (study group), with the standard Clomid/hMG regime (control group). Fifty one patients in the study group were carefully matched for patient age, infertility diagnosis (female), semen parameters, number of follicles, and number of oocytes transferred into consideration with a control group. RESULTS: The overall pregnancy rate was 21.6% (11/51) in the study group and 47% (24/51) in the control group (P = 0.01). However, the ongoing pregnancy rate in the two groups did not differ significantly, 11.8% (6/51) vs 27.5% (14/51) (P = 0.08). In the study group, 7.8% of patients had to be seen over a weekend, compared to 13.7% in the control group (not significant). CONCLUSION: From the findings we conclude that, although this method of controlling cycles can be useful in selected patients, it is not the ultimate method.

Adult↗

PubMed2005