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Biomedical subjects

T Levy

Publications and source records attributed to T Levy.

At least 55 records · Page 3Linked to original sources
PubMed1997

A phase I study of TNP-470 administered to patients with advanced squamous cell cancer of the cervix.

A Phase I study of the novel angiogenesis inhibitor TNP-470 was performed. Patients with inoperable recurring or metastatic squamous cell cancer of the cervix with evaluable disease, no coagulopathy, and adequate renal, hepatic, and hematological function were eligible. One course of treatment consisted of an i.v. infusion of TNP-470 over 60 min every other day for 28 days, followed by a 14-day rest period. The starting dose was 9.3 mg/m2. Eighteen evaluable patients were treated, with a median age of 48 years (range 27-55) and performance status Zubrod 1 (range 0-2). Grade 3 neurotoxicities consisting of weakness, nystagmus, diplopia, and ataxia were encountered in two patients receiving the 71.2 mg/m2 dose. An intermediate dose level of 60 mg/m2 was evaluated and found to be well tolerated by three patients. Only one patient experienced grade 3 nausea on the 60 mg/m2 dose level. No myelosuppression, retinal hemorrhage, weight loss, or significant alopecia were observed. One patient had a complete response, which continues for 26 months, and three patients with initially progressive disease stage had stable disease for 5, 7.7, and 19+ months. Other Phase I studies, including over 200 patients, were performed concurrently with this study. Based on this experience, the dose of TNP-470 recommended for further studies is 60 mg/m2 as a 60-min i.v. infusion every Monday, Wednesday, and Friday. Neurotoxicity was dose limiting, but appears to be reversible. Otherwise, the treatment was well tolerated. The drug may be active in squamous cell cancer of the cervix. Further studies of TNP-470 in squamous cell cancer of the cervix are warranted.

Adult↗
PubMed1996

The residual ovary syndrome: a 20-year experience.

OBJECTIVE: To address the controversy of ovarian preservation during a hysterectomy for benign indications by using our experience with residual ovary syndrome (ROS). STUDY DESIGN: Over a period of 20 years, 2561 hysterectomies (during which one or both ovaries were preserved) were performed at the Golda Medical Center, Israel. A retrospective, quasi, case-control analysis was undertaken. RESULTS: The incidence of ROS was 2.85%. While chronic pelvic pain was the principle indication for subsequent reexploration in 52 patients (71.3%), an asymptomatic pelvic mass noted during routine follow-up examination accounted for 24.6% of operations for ROS. The majority (75.4%) of patients underwent surgery during the first 10 years, while the highest incidence occurred within the first 5 years (46.6%). Furthermore, histological examination revealed functional cysts, benign neoplasm and ovarian carcinoma in 50.7%, 42.6% and 12.3% of the cases, respectively (in nine patients more than one pathology was observed). CONCLUSIONS: Since ROS was found to occur in 1/35 women who had undergone previous hysterectomies mainly due to physiologic ovarian function and benign cyst formation, but not malignancy, we believe that routine oophorectomy is justified in premenopausal women over 45 years of age. However, the final decision to perform elective oophorectomy at the time of hysterectomy for benign disease should be established on an individual basis, taking into consideration age, individual and family risk factors, the patient's preference and ability to ensure long-term compliance to exogenous hormone replacement therapy.

Adult↗
PubMed1996

Severe ovarian hyperstimulation syndrome despite low plasma oestrogen concentrations in a hypogonadotrophic, hypogonadal patient.

Ovarian hyperstimulation syndrome (OHSS) is the most serious, life-threatening, iatrogenic complication of ovulation induction. The importance of excessive oestradiol concentrations on the day of human chorionic gonadotrophin (HCG) administration as a predictor and factor in the pathophysiology of OHSS has been extensively studied and discussed. We present the case report of a woman with hypogonadotrophic hypogonadism who developed severe OHSS during ovulation induction with urinary human follicle stimulating hormone (FSH) and HCG in the presence of low circulating oestradiol concentrations. The implication of FSH treatment and complications in hypogonadotrophic hypogonadal patients, and the role of preovulatory oestradiol concentrations in the prediction of OHSS, are discussed.

Adult↗
PubMed1996

Preliminary report of the activity of docetaxel in advanced or recurrent squamous cell cancer of the cervix.

Eighteen patients with squamous cell cancer of the cervix were treated with i.v. docetaxel 100 mg/m2 over 1 h every 21 days. No patient received prior chemotherapy, except as a radiation sensitizer. Median age was 42 years (range 30-58) and Zubrod performance status was 1 (0-2). Ten (59%) patients had prior surgery and 11 (65%) had prior radiation therapy. Sixteen patients were evaluable for response. Two patients had a partial response (13%; 95% CI 0-32%) and eight (50%; 95% CI 23-77%) had stable disease. Dose reduction to 75 mg/m2 was required in 10 patients and to 55 mg/m2 in one patient. Granulocytopenia was the major hematopoietic toxicity (31% grade 3 and 44% grade 4). Docetaxel is active in patients with squamous cell cancer of the cervix and may be tolerable at this dose schedule.

Adult↗
PubMed1995

Pharmacokinetics of follicle-stimulating hormone: clinical significance.

OBJECTIVE: To review studies that examine the pharmacokinetics and pharmacodynamics of endogenous, as well as several exogenous FSH preparations. DESIGN: Related studies were identified through a computerized bibliographic search. PATIENTS: Initial pharmacodynamic studies were done in animal models and in women and men with either hypogonadotropic hypogonadism or suppressed hypothalamic-pituitary-gonadal axis. More recent studies evaluated FSH pharmacokinetics during ovulation induction treatment in women with normal ovulatory cycles or polycystic ovarian syndrome. RESULTS: Various types of FSH exist according to their sialic acid content. High estrogen levels induce the secretion of less sialylated molecules with higher receptor affinity and an increased clearance rate. It appears that there is a threshold FSH level that should be reached to achieve an ovarian response. A very narrow range exists between the threshold and ceiling level for monofollicular growth. This threshold level is surpassed intentionally during IVF treatment cycles to induce multiple follicular recruitment. The threshold level can change under situations such as polycystic ovaries, perimenopause, oral contraceptives, and GnRH analogue treatment. CONCLUSIONS: To avoid the risk of ovarian hyperstimulation syndrome and multiple pregnancies, careful adjustments of serum FSH levels should be made by fine dosage modifications. By monitoring FSH levels and using less sialylated preparations, the efficacy of the treatment probably will improve.

Animals↗
PubMed1995

A comparative prospective study of conventional regimen with chronic low-dose administration of follicle-stimulating hormone for anovulation associated with polycystic ovary syndrome.

OBJECTIVE: To compare efficiency of conventional and chronic low-dose regimens for treatment of anovulation associated with polycystic ovary syndrome (PCOS). DESIGN: Fifty participants divided into two equal groups. The first group was treated with urinary human FSH using a conventional stepwise protocol and the second group was treated with a regimen of chronic low-dose and small incremental rises with urinary human FSH or with recombinant human FSH for a maximum of three cycles. SETTING: Tertiary referral university hospital fertility unit. PATIENTS: Fifty infertile women with clomiphene citrate-resistant anovulation associated with PCOS. MAIN OUTCOME MEASURES: Pattern of follicular development, amount of FSH required, serum E2 concentrations, cycle fecundity, cumulative conception, and live birth rates. Multiple pregnancy and ovarian hyperstimulation syndrome (OHSS) rates. RESULTS: Compared with the conventional dose protocol, the chronic low-dose regimen yielded slightly improved pregnancy rates (40% versus 24%) while completely avoiding OHSS and multiple pregnancies, which were prevalent (11% and 33%, respectively) with conventional therapy. Monofollicular development was induced in 74% versus 27% of cycles, and the total number of follicles > 16 mm and E2 concentrations were half those observed on conventional therapy. CONCLUSIONS: For women with PCOS, a chronic low-dose regimen of FSH eliminated complications of OHSS and multiple pregnancies while maintaining a satisfactory pregnancy rate. This modality, thus, has distinct advantages and could well replace conventional gonadotropin therapy for these patients.

Adult↗
PubMed1995

Adjuvant growth hormone for induction of ovulation with gonadotrophin-releasing hormone agonist and gonadotrophins in polycystic ovary syndrome: a randomized, double-blind, placebo controlled trial.

The objective of this study was to explore the effect of cotreatment with recombinant human growth hormone (GH), gonadotrophin-releasing hormone agonist (GnRHa) and human menopausal gonadotrophin (HMG) for induction of ovulation in women with clomiphene resistant polycystic ovary syndrome (PCOS). It was designed as a randomized, double-blind, placebo controlled trial in which 30 women with anovulation associated with PCOS who were resistant to clomiphene all received DTRP6-LHRH (Decapeptyl microcapsules, 3.75 mg, i.m.) and, 2 weeks later, HMG in a standard, conventional, individually adjusted dose regimen until human chorionic gonadotrophin (HCG) and then luteal phase support could be given. From day 1 of HMG therapy, patients were randomized to receive either human GH (Norditropin, 12 IU/day, i.m., for 7 days) or placebo. The number of ampoules, duration of treatment and daily effective dose of HMG required to achieve ovulation, serum oestradiol concentrations and number of follicles induced, ovulation and pregnancy rates, serum insulin and insulin-like growth factor-I (IGF-I) concentrations were measured. There were no significant differences between growth hormone and placebo groups in any of the outcomes measured, other than a growth hormone induced increase in serum insulin and IGF-I levels. We conclude that although GH kinetics are abnormal and GH pituitary reserves generally low in women with PCOS, adjuvant GH treatment to GnRHa/HMG does not influence follicular development or sensitivity in response to gonadotrophins and that it does not seem likely to be of any potential clinical benefit for the treatment of PCOS.

Adult↗
PubMed1995

Laparoscopic unwinding of hyperstimulated ischaemic ovaries during the second trimester of pregnancy.

Successful unwinding of large, hyperstimulated, ischaemic-haemorrhagic adnexa by laparoscopy during the second trimester of pregnancy is described. Three women in their second trimester of pregnancy were treated by laparoscopy. In all cases, the ovaries were unwound and replaced in their anatomical position. Shortly after the procedure they became pink. Serial ultrasound examinations showed viable, intrauterine fetuses and ovaries with normal blood flow. Laparoscopic ovarian detorsion is a safe and easy procedure, and can be carried out in advanced gestation until approximately 20th week if special safety measures are adhered to.

Adult↗
PubMed1994

The role of intrapartum vibroacoustic stimulation in the prediction of neonatal myasthenia gravis.

BACKGROUND: The exact mechanism for the development of neonatal myasthenia gravis is unclear, and the occurrence of neonatal myasthenia gravis cannot be predicted. CASE: A case of normal duration of fetal forearm extention with return to flexion in response to vibroacoustic stimulation, and the pertinent details concerning neonatal myasthenia gravis and vibroacoustic stimulation test are described. CONCLUSIONS: Inasmuch as fetal acoustic stimulation test results in a fetal reaction resembling the startle response of the newborn, we think that it will worthwhile to perform this test antenatally in the next encountered fetuses of myasthenic mothers in order to assess its role in the prediction of neonatal myasthenia gravis.

Acoustic Stimulation↗
PubMed1993

Gonadotropin-releasing hormone agonist reduces the miscarriage rate for pregnancies achieved in women with polycystic ovarian syndrome.

OBJECTIVE: To compare the effect of treatment with gonadotropin-releasing hormone agonist (GnRH-a) and human menopausal gonadotropins (hMG) with that of gonadotropins only, on the cumulative livebirth rate and miscarriage rate of pregnancies achieved in women with polycystic ovarian syndrome (PCOS). DESIGN: Retrospective analysis of the outcome of 97 pregnancies according to the treatment protocol, with or without GnRH-a. Calculation of miscarriage rate and cumulative livebirth rate by life-table analysis. SETTING: Infertility clinic and in vitro fertilization (IVF) unit. PATIENTS: Women with polycystic ovaries (n = 239) who were clomiphene citrate failures and received either GnRH-a/hMG (n = 110) or gonadotropins only (n = 129) for ovulation induction (n = 138) or superovulation for IVF (n = 101). INTERVENTIONS: For ovulation induction, hMG was given in a step-up, individually adjusted dose scheme. For IVF, three ampules of pure follicle-stimulating hormone were given for 3 days followed by three ampules per day hMG and then individual dose adjustment. Gonadotropin-releasing hormone agonist (Decapeptyl, D-Trp6, microcapsules, 3.75 mg) was given in a single dose 2 weeks before gonadotropin treatment. MAIN OUTCOME MEASURES: The rate of early miscarriages (< 12 weeks) per pregnancies achieved was analyzed, and the cumulative livebirth rate for each treatment group was calculated by life-table analysis. RESULTS: Miscarriage rates after treatment in ovulation induction with (16.7%) and without GnRH-a (39.4%) and in IVF with (18.2%) and without GnRH-a (38.5%) were almost identical and were therefore analyzed together. Of pregnancies achieved with GnRH-a, 17.6% miscarried compared with 39.1% of those achieved with gonadotropins alone. Cumulative livebirth rate after four cycles for GnRH-a was 64% compared with 26% for gonadotropins only. CONCLUSIONS: Cotreatment with GnRH-a/hMG for anovulatory women with PCOS reduces the miscarriage rate and improves the livebirth rate compared with treatment with gonadotropins alone.

Abortion, Spontaneous↗
PubMed1993

Severe abdominal complications after transvaginal ultrasonographically guided retrieval of oocytes for in vitro fertilization and embryo transfer.

Severe life-threatening complications as a result of ultrasonically guided ovum pick-up for IVF may rarely occur. We report 14 cases, out of 3,656 patients undergoing the procedure, presenting with a clinical picture of acute abdomen. In 9 patients tubo-ovarian and pelvic abscess were diagnosed; 3 were treated by laparotomy, whereas in the other 6, culdocentesis and drainage were performed. In 3 cases severe intra-abdominal bleeding occurred with 1 requiring laparotomy and hemostasis, whereas in the others laparoscopic drainage and hemostasis were sufficient. Ruptured endometriotic cystic masses caused acute abdomen in 2 patients; partial oophorectomy and drainage were essential operative procedures. We conclude that although severe postovum retrieval complications are rare, one has to be aware of their occurrence with the aim of accurate diagnosis and prompt intervention.

Abdomen, Acute↗
PubMed1993

In vitro fertilization and embryo transfer for the treatment of infertility associated with polycystic ovary syndrome.

OBJECTIVE: To examine the outcome of treatment with IVF-ET of women with polycystic ovarian syndrome (PCOS) who failed to conceive on conventional treatment. DESIGN: Retrospective analysis with an age-matched control group. SETTING: University hospital infertility clinic and IVF unit. PATIENTS. INTERVENTIONS: Sixty-eight women with PCOS who had failed to conceive on treatment with clomiphene citrate and during six ovulatory cycles on gonadotropins underwent 208 cycles of IVF-ET. An age-matched group of 68 women with a tubal mechanical factor who received 143 treatment cycles during the same period served as controls. MAIN OUTCOME MEASURES: Cumulative conception rates, the cumulative livebirth rates, and IVF-ET data were compared between the two groups. Results of treatment with and without GnRH agonist (GnRH-a) within the groups were also compared. RESULTS: A comparison of PCOS and mechanical factor (control) groups showed almost identical results at 6 months for cumulative conception rate (82% versus 85%) and cumulative livebirth rate (69% versus 65%). Significantly more oocytes were retrieved but a smaller percentage fertilized in PCOS, and the pregnancy rate per ET did not differ between the two groups (23% versus 26%). Treatment with GnRH-a and gonadotropins as opposed to gonadotropins alone improved the cumulative conception rate, miscarriage rate, and cumulative livebirth rate in the PCOS but not in the control group and improved fertilization rates in both groups. CONCLUSIONS: For patients with PCOS who fail to conceive with gonadotropin treatment, IVF-ET is a successful treatment alternative, producing results equal to those for women with a mechanical tubal factor. Better results were achieved with GnRH-a in women with PCOS but made no difference to those with a mechanical tubal factor compared with treatment with gonadotropins alone.

Adult↗
PubMed1993

Another look at co-treatment with growth hormone and human menopausal gonadotrophins in poor ovarian responders.

The objective of this study was to evaluate whether a combined human growth hormone (HGH) and human menopausal gonadotrophin (HMG) treatment can improve ovulation induction in poor ovarian responders. Ten patients aged 28-43 years and requiring > 25 ampoules of HMG for ovulation were admitted to the study. Pituitary growth hormone reserve was evaluated by clonidine stimulation and insulin tolerance tests before commencement of treatment. The patients underwent one treatment cycle with D-tryptophan-6-luteinizing hormone-releasing hormone (D-Trp6-LHRH) and HMG and another cycle with D-Trp6-LHRH, HMG and HGH. Serum HGH, insulin-like growth factor (IGF)-I and oestradiol were measured throughout the two treatment cycles and follicular maturation was assessed by ultrasonographic studies. All patients tested showed no elevation of their serum HGH concentration during a clonidine test, but showed an adequate response during insulin tolerance tests. No significant difference was found in the number of HMG ampoules, duration of treatment, number of leading follicles, and serum oestradiol concentration between the two treatment cycles. Co-treatment with HGH and HMG did not improve ovarian performance in poor ovarian responders. No correlation was found between the results of HGH pituitary function tests and the ovarian response to gonadotrophins.

Adult↗
PubMed1992

The impact of long-term gonadotropin-releasing hormone analogue treatment on preclinical abortions in patients with severe endometriosis undergoing in vitro fertilization-embryo transfer.

OBJECTIVE: To examine the relationship between endometriosis and preclinical abortions and to evaluate the effect of gonadotropin-releasing hormone analogue (GnRH-a) therapy on these pregnancies. DESIGN AND PATIENTS: Of 67 women with severe endometriosis referred to us for in vitro fertilization-embryo transfer (IVF-ET), 32 underwent ovarian stimulation for oocyte retrieval with menotropins (protocol A), whereas the other 35 were admitted for the procedure after a 6-month period of hormonal suppression with a GnRH agonist (protocol B). The clinical impact of the preclinical and clinical pregnancies in both treatment protocols were evaluated on the basis of oocyte classification and embryo quality score. SETTING: All patients were treated in our IVF Unit. MAIN OUTCOME MEASURE: Clinical pregnancy was used as our main outcome measure of success. RESULTS: A significantly higher number of preclinical pregnancies (P less than 0.0001) occurred in patients treated by protocol A. After GnRH-a treatment, the preclinical pregnancy rate declined significantly (P less than 0.0001), whereas the clinical pregnancy rate per cycle and per transfer rose significantly (P less than 0.0001 and P less than 0.0001, respectively). Furthermore, clinical pregnancies had a significantly better mean embryo quality score in comparison with preclinical pregnancies (P less than 0.0001). CONCLUSIONS: It is concluded that combining GnRH-a therapy before IVF-ET provides an improved treatment modality for preclinical abortions and infertility associated with severe endometriosis.

Abortion, Spontaneous↗
PubMed1991

Age and pregnancy rates in in vitro fertilization.

The influence of women's age on the results of in vitro fertilization (IVF) was analyzed in 1801 women undergoing the procedure. Advancing age was found to be related to significant reduced success rates from an average of 30.1% per transfer below the age of 36 years to 15.9% per transfer at 37 years or more (P less than 0.001). The decrease was related to a reduction in oocyte production (five at 25 years or less, four below the age of 40 years, three at 40 years or more, and two in the 43 to 47-year group) and probably due to reduced implantation. It is concluded that a woman's age must be considered an important prognostic factor when IVF is suggested.

Adult↗