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PubMed2004

17 alpha-hydroxyprogesterone caproate versus intravaginal progesterone in IVF-embryo transfer cycles: a prospective randomized study.

One of the main issues in the management of IVF and embryo transfer techniques is to ensure adequate concentrations of progesterone. The aim of this prospective, randomized study was to compare the effectiveness of 17 alpha -hydroxyprogesterone caproate (17-HPC) administered intramuscularly and intra-vaginal progesterone in gel in luteal phase support in patients undergoing IVF-embryo transfer cycles. A total of 320 patients were randomly treated with either 17-HPC (341 mg i. m. every 3 days) or progesterone vaginal gel (90 mg daily). The inclusion criteria were the use of gonadotrophin-releasing hormone down-regulation and age <40 years. The outcome of IVF in both study groups was evaluated for implantation rate, biochemical pregnancy, clinical pregnancy, miscarriage, and ongoing pregnancy rate. The results of this study showed that 17-HPC conferred more benefit to IVF-embryo transfer cycles compared with intra-vaginal progesterone, as demonstrated by the results of most of the main outcome parameters considered. The data showed that 17-HPC administered every 3 days appears to be more effective in providing luteal support in comparison to intra-vaginal progesterone.

17 alpha-Hydroxyprogesterone Caproate↗
PubMed1986

Metabolism of 17-hydroxyprogesterone by a Bacillus species.

Fermentation of 17-hydroxyprogesterone with a Bacillus species (IICB-301) in a modified nutrient medium under aerobic conditions yielded androst-4-ene-3,17-dione and 15 alpha,17-dihydroxypregn-4-ene-3,20-dione in addition to a new pregnane analogue, 6 beta,17,20 alpha-trihydroxypregn-4-ene-3-one. Each microbial metabolite was characterized by the application of various spectroscopic techniques. The availability of the new metabolite, 6 beta,17,20 alpha-trihydroxypregn-4-ene-3-one, enabled complete elucidation of its 13C-n.m.r. spectrum.

17-alpha-Hydroxyprogesterone↗
PubMed1986

Studies on the diurnal variations of 17-hydroxyprogesterone in saliva by enzyme immunoassay in patients with congenital adrenal hyperplasia.

The diurnal rhythm of 17-hydroxyprogesterone concentration in the saliva was determined in 11 patients with congenital adrenal hyperplasia ranging in age from 9 to 20 years. A total of 21 tests were performed using a 17-OHP-enzyme immunoassay. The investigations were carried out during normal school or working days. The tests were done 16 times in patients with optimal therapeutic control and 5 times in patients with undertreatment. The concentrations of saliva 17-OHP in the morning were significantly lower after a therapy interval during the night of 8 hours than of more than 10 hours. In patients with poor substitution all values of the days were higher than in patients with optimal therapy control. The morning values are appropriate for the evaluation of the therapy control. With regular 8 hours' therapy intervals the limit between normal and pathological values may be about 500 pmol/l saliva.

17-alpha-Hydroxyprogesterone↗
PubMed1988

[Salivary 17-hydroxyprogesterone concentration in monitoring of the treatment of congenital adrenal hyperplasia].

The salivary concentration of 17-hydroxyprogesterone (17-OHP) was determined in 11 patients (aged 6 months to 13 years) with congenital adrenogenital syndrome (AGS) due to C21-hydroxylase deficiency and six healthy controls, in order to assess its value in monitoring treatment of AGS. Salivary 17-OHP was measured by a specific radioimmunoassay after extraction with dichloromethane. Only 100 microliters of saliva was needed for the assay. There was a good correlation (r = 0.93; P less than 0.01) between 17-OHP concentrations in paired saliva and serum samples from the patients and the control subjects. There was a wide scatter in salivary 17-OHP levels in the range between 164 ng/l (1.7 ng/ml in serum) of satisfactorily or overtreated patients and 15,500 ng/l (247 ng/l in serum) of undertreated patients. Levels in normal children were between 200 and 300 ng/l. It is concluded that treatment of congenital AGS (21-hydroxylase deficiency) can be carefully monitored in children with the noninvasive, frequently repeatable measurement of salivary 17-OHP.

17-alpha-Hydroxyprogesterone↗
PubMed2003

Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate.

BACKGROUND: Women who have had a spontaneous preterm delivery are at greatly increased risk for preterm delivery in subsequent pregnancies. The results of several small trials have suggested that 17 alpha-hydroxyprogesterone caproate (17P) may reduce the risk of preterm delivery. METHODS: We conducted a double-blind, placebo-controlled trial involving pregnant women with a documented history of spontaneous preterm delivery. Women were enrolled at 19 clinical centers at 16 to 20 weeks of gestation and randomly assigned by a central data center, in a 2:1 ratio, to receive either weekly injections of 250 mg of 17P or weekly injections of an inert oil placebo; injections were continued until delivery or to 36 weeks of gestation. The primary outcome was preterm delivery before 37 weeks of gestation. Analysis was performed according to the intention-to-treat principle. RESULTS: Base-line characteristics of the 310 women in the progesterone group and the 153 women in the placebo group were similar. Treatment with 17P significantly reduced the risk of delivery at less than 37 weeks of gestation (incidence, 36.3 percent in the progesterone group vs. 54.9 percent in the placebo group; relative risk, 0.66 [95 percent confidence interval, 0.54 to 0.81]), delivery at less than 35 weeks of gestation (incidence, 20.6 percent vs. 30.7 percent; relative risk, 0.67 [95 percent confidence interval, 0.48 to 0.93]), and delivery at less than 32 weeks of gestation (11.4 percent vs. 19.6 percent; relative risk, 0.58 [95 percent confidence interval, 0.37 to 0.91]). Infants of women treated with 17P had significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen. CONCLUSIONS: Weekly injections of 17P resulted in a substantial reduction in the rate of recurrent preterm delivery among women who were at particularly high risk for preterm delivery and reduced the likelihood of several complications in their infants.

17 alpha-Hydroxyprogesterone Caproate↗
PubMed2005

Efficacy and safety of 17alpha-hydroxyprogesterone caproate in hormone replacement therapy.

The aim of the present study was to evaluate the efficacy (in terms of induction of uterine bleeding) and safety (in terms of absence of endometrial hyperplasia) of 17alpha-hydroxyprogesterone caproate (17alpha-HPC) in a therapeutic regimen for hormonal replacement after menopause. Fifty postmenopausal patients received hormone replacement therapy (HRT) for 24 weeks. The treatment regimen consisted of standard estrogen replacement therapy at commonly prescribed doses for the prevention of climacteric symptoms and 341 mg of 17alpha-HPC every 30 days. Enrolled women were told to expect withdrawal bleeding 7-10 days after the administration of 17alpha-HPC. Forty-eight patients completed the trial. In 91.7% of cases, patients experienced the expected pattern, i.e., strict withdrawal bleeding exclusive of any other form of bleeding. Breakthrough bleeding and/or other forms of abnormal bleeding affected only four women. At the 6th month none of the endometrial samplings motivated by endometrial thickness >10 mm and evidence of heterogeneous echogenicity (two cases) was positive for carcinoma. No biopsies had to be performed at the end of the 12th month of treatment. No serious adverse effect where recorded during the study period. In conclusion, our data show the efficacy and safety of 17alpha-HPC in HRT.

17 alpha-Hydroxyprogesterone Caproate↗
PubMed1992

The effect of 17 alpha-hydroxyprogesterone caproate/oestradiol valerate on the development and outcome of early pregnancies following in vitro fertilization and embryo transfer: a prospective and randomized controlled trial.

A prospective and randomized study was performed to investigate the effect of supportive hormones on the development and outcome of early pregnancies following in vitro fertilization and embryo transfer. Immediately after pregnancies were confirmed endocrinologically on day 15 after oocyte collection, 17 alpha-hydroxyprogesterone caproate and oestradiol valerate (PC/EV) was administered to half of the patients in a randomly controlled trial. One group received supportive treatment until the twelfth week of gestation, whereas the other group received no treatment at all. Both groups were followed up by measurements of serum levels of human chorionic gonadotrophin (HCG), oestradiol and progesterone every three days until day 35, when a first ultrasound examination was carried out to confirm fetal vitality. Subsequently, pregnancies were monitored sonographically at regular intervals. In cases of miscarriage, dilatation and curettage was performed and histology analysed. A total of 120 pregnant patients entered the study: 55 of them received hormone treatment and 65 patients were controls. Within the treatment group 48 (89%) clinically ongoing pregnancies were observed, five (9%) miscarriages occurred after the seventh week of gestation and one preclinical pregnancy was noted. In the control group, 38 (59%) ongoing pregnancies were observed, nine (14%) miscarriages occurred and 17 (27%) preclinical pregnancies were recorded. Two ectopic pregnancies, one in each group, were excluded from evaluation. A significantly higher percentage of pregnancies were intact at 7 weeks of gestation after treatment with PC/EV (p less than or equal to 0.01).

17 alpha-Hydroxyprogesterone Caproate↗
PubMed1984

Source and regulation of 17 alpha-hydroxyprogesterone during baboon pregnancy.

The present study determined the source and regulation of 17 alpha-hydroxyprogesterone (17-OHP4) during mid-late baboon pregnancy. Serum 17-OHP4 (ng/ml) in 5 untreated baboons increased from low values at mid-late gestation to a mean (+/- SEM) of 0.49 +/- 0.02 during the final 20 days of gestation. Fetectomy of 5 baboons resulted in serum 17-OHP4 concentrations which declined to and remained at baseline. Serum 17-OHP4 concentrations were 5- to 10-fold greater (P less than 0.001) in the uterine, utero-ovarian, and umbilical veins than peripherally. Apparently the fetal adrenal provides precursors for placental 17-OHP4 formation because the fetal adrenal gland develops delta 5-3 beta-hydroxysteroid dehydrogenase only late in gestation, and because the fetal adrenal and not the placenta has the capacity for 17-hydroxylation. Thus, at mid-late gestation the placenta appears to supply a major, and at term the corpus luteum a minor portion of the total 17-OHP4. Administration of the estrogen antagonist ethamoxytriphetol (MER-25, 15 mg/kg BW) to 4 baboons did not affect 17-OHP4 during mid-late gestation, when the placenta was the only source of 17-OHP4. However, MER-25 resulted in serum 17-OHP4 concentrations (ng/ml) at term which were greater (1.08 +/- 0.10, P less than 0.001) than in untreated baboons (0.49 +/- 0.02). Prior removal of the corpus luteum of pregnancy in 4 animals subsequently given MER-25 prevented this rise in 17-OHP4. This suggests that the marked elevation in 17-OHP4 observed near term after MER-25 administration was of luteal origin and that antiestrogen enhanced 17-OHP4 secretion by the corpus luteum.

17-alpha-Hydroxyprogesterone↗
PubMed2005

Estimated effect of 17 alpha-hydroxyprogesterone caproate on preterm birth in the United States.

OBJECTIVE: A multicenter, randomized placebo-controlled trial among women with singleton pregnancies and a history of spontaneous preterm birth found that weekly injections of 17 alpha-hydroxyprogesterone caproate (17P), initiated between 16 and 20 weeks of gestation, reduced preterm birth by 33%. The current study estimated both preterm birth recurrence and the potential reduction in the national preterm birth rate. METHODS: Using 2002 national birth certificate data, augmented by vital statistics from 2 states, we estimated the number of singleton births delivered to women eligible for 17P through both a history of spontaneous preterm birth and prenatal care onset within the first 4 months of pregnancy. The number and rate of recurrent spontaneous preterm births were estimated. To predict effect, the reported 33% reduction in spontaneous preterm birth attributed to 17P therapy was applied to these estimates. RESULTS: In 2002, approximately 30,000 recurrent preterm births occurred to women eligible for 17P, having had a recurrent preterm birth rate of 22.5%. If 17P therapy were delivered to these women, nearly 10,000 spontaneous preterm births would have been prevented, thereby reducing the overall United States preterm birth rate by approximately 2%, from 12.1% to 11.8% (P < .001), with higher reductions in targeted groups of eligible pregnant women. CONCLUSION: Use of 17P could reduce preterm birth among eligible women, but would likely have a modest effect on the national preterm birth rate. Additional research is urgently needed to identify other populations who might benefit from 17P, evaluate new methods for early detection of women at risk, and develop additional prevention strategies. LEVEL OF EVIDENCE: III.

17 alpha-Hydroxyprogesterone Caproate↗
PubMed1993

17-Hydroxyprogesterone response to buserelin testing in the polycystic ovary syndrome.

OBJECTIVE: We determined the 17-hydroxyprogesterone (17-OH P) response to buserelin, a GnRH agonist, and its relation to ovarian volume in the patients with polycystic ovary syndrome (PCOS). DESIGN: We compared 17-OH P response to buserelin in a large group of patients with that in a control group of healthy women. We also investigated whether there is any relation between LH-induced 17-OH P production in response to buserelin and ovarian volume. PATIENTS: Ten normal women and 31 women with PCOS were included in the study. MEASUREMENT: Pelvic ultrasound examination by abdominal or vaginal transducer was performed. Serum basal levels of LH, FSH, free testosterone and 17-OH P were measured by radioimmunoassay. 17-OH P responses to both ACTH and buserelin were detected. Cortisol levels were measured before and after dexamethasone suppression. RESULTS: The subcutaneous administration of 1 mg buserelin produced an increase in serum 17-OH P, which peaked within 24 hours in all groups. The mean +/- SEM level of 17-OH P, 24 hours after buserelin stimulation in the women with PCOS (15.94 +/- 1.31 nmol/l) was significantly higher (P < 0.001) than in the control group (6.75 +/- 0.69 nmol/l). The women with PCOS had increases in 17-OH P levels exceeding 10.15 nmol/l 24 hours after buserelin testing. The increased 17-OH P responses to buserelin were unchanged by pretreatment with dexamethasone to suppress adrenal function. The 17-OH P response was significantly related to ovarian volume (r = 0.53, P < 0.01). CONCLUSIONS: Our findings suggest that the serum 17-OH P response to a 1-mg subcutaneous test dose of buserelin may be a diagnostic and practical test for PCOS. increased ovarian volume in PCOS may be responsible for the elevated 17-OH P response to buserelin, a GnRH agonist, at least in some patients.

17-alpha-Hydroxyprogesterone↗
PubMed1994

Augmented 17 alpha-hydroxyprogesterone response to ACTH stimulation as evidence of decreased 21-hydroxylase activity in patients with incidentally discovered adrenal tumours ('incidentalomas').

OBJECTIVE: Recent studies have indicated that the syndrome of congenital adrenal hyperplasia due to 21-hydroxylase deficiency is closely associated with the development of benign adrenocortical tumours. Tumour formation is thought to be a consequence of ACTH hypersecretion which results from the lack of glucocorticoid synthesis. The aim of this study was to evaluate 21-hydroxylase activity in patients with an incidentally discovered adrenal mass ('incidentaloma') without a history of congenital adrenal hyperplasia. DESIGN: A prospective study of 52 patients admitted to a single hospital. PATIENTS: Fifty-two consecutive subjects (mean age 56.0 years, range 24-81 years) with an incidentally discovered adrenal tumour were studied. MEASUREMENTS: The 21-hydroxylase reserve was assessed by intravenous bolus administration of 1-24 ACTH (tetracosactrin) with measurement of basal and stimulated serum 17 alpha-hydroxyprogesterone (17-OHP) concentrations. Impaired 21-hydroxylase activity was defined as an exaggerated 17-OHP response, with a 17-OHP increment exceeding 7.9 nmol/l. Basal and stimulated cortisol concentrations, and basal ACTH were also measured. RESULTS: Baseline levels of 17-OHP were normal in 44 and elevated in 8 subjects. In 37 patients (71.2%), the 17-OHP increment following ACTH administration exceeded 7.9 nmol/l, demonstrating mildly decreased 21-hydroxylase activity. In these subjects, the peak serum 17-OHP correlated with the tumour diameter. In the patients with apparently normal 21-hydroxylase activity, no significant correlation was found between 17-OHP concentrations and tumour size. All patients had a stimulated serum cortisol above 550 nmol/l reflecting intact adrenal glucocorticoid reserve. There were no other differences between the group with exaggerated and the group with normal 17-OHP increment. The tumours were removed from two women with augmented 17-OHP responses and this was followed by normalization of 17-OHP dynamics. CONCLUSIONS: Biochemical evidence for partial 21-hydroxylase defiency is a common finding in patients with an adrenal incidentaloma, even in the absence of a congenital adrenal hyperplasia history. Exaggerated 17-OHP increment is not accompanied by decreased adrenal glucocorticoid reserve. Normalization of the 17-OHP response after surgical treatment suggests that the phenomenon results from reduced 21-hydroxylase activity in the tumour, which retains ACTH responsiveness.

17-alpha-Hydroxyprogesterone↗
PubMed1995

In vitro fertilization and the effect of progesterone and 17 alpha-hydroxyprogesterone on acrosome reaction of mouse epididymal spermatozoa.

This study assessed the effect of progesterone and 17 alpha-hydroxyprogesterone (17 alpha-OH-progesterone) at concentrations of 0.01-10 micrograms/ml, on the acrosome reaction and in vitro fertilizing ability of mouse epididymal spermatozoa. Cumulus masses containing oocytes were cultured in Brinster's medium, to which were added capacitated epididymal spermatozoa which had been incubated in medium with various concentrations of progesterone or 17 alpha-OH-progesterone for 90 min. IVF success rate was assessed 20-24 h following insemination. Progesterone was found to increase the fertilization rate at the 1 microgram/ml and 10 microgram/ml concentrations while lower concentrations had no effect. However, 17 alpha-OH-progesterone failed to show any effect on fertilizing ability. Incubation of epididymal spermatozoa in medium containing 1 microgram/ml and 10 micrograms/ml progesterone significantly increased the acrosome reaction as monitored by a chlortetracycline fluorescence assay. 17 alpha-OH-progesterone, however, failed to show any effect on the acrosome reaction. The results suggest direct effects of progesterone, but not of 17 alpha-OH-progesterone, on fertilization and the acrosome reaction of mouse spermatozoa.

17-alpha-Hydroxyprogesterone↗
PubMed1987

The effects of naloxone, dexamethasone, deoxycorticosterone and 17-hydroxyprogesterone on blood pressure responses of normal and adrenalectomized rats during hypovolaemic shock.

The roles of, and interactions between, steroids and naloxone, an opioid antagonist, in the reversal of experimental hypotensive shock were studied in normal and adrenalectomized rats. In normal rats treated with dexamethasone or deoxycorticosterone or 17-hydroxyprogesterone the hypotension and shock caused by 1% bodyweight and 2% bodyweight haemorrhage could be substantially reversed by naloxone in a dose-related manner. In contrast, the reversal of hypotension by naloxone was markedly less in adrenalectomized rats. It is concluded that there is a co-ordinate release of pressor catecholamines and depressor enkephalins from adrenal glands in hypovolaemic shock. Eventually, the use of naloxone would be of much less value in the treatment of hypotension or shock in patients with Addison's disease.

17-alpha-Hydroxyprogesterone↗
PubMed1995

Urinary 17 alpha-hydroxyprogesterone in management of 21-hydroxylase deficiency.

OBJECTIVES: The study was designed to assess the reliability of measurement of 24-hour urinary 17 alpha-hydroxyprogesterone (17-OHP) by radio-immunoassay (RIA) as an alternative biochemical assessment for monitoring the treatment of congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD) and to assess the need for sample purification by column chromatography to improve assay specificity. METHODOLOGY: Morning serum 17-OHP was measured using RIA and 24-hour urinary pregnanetriol using gas chromatography. Twenty-four-hour urinary 17-OHP was measured in samples from 17 prepubertal patients with CAH due to 21-OHD, and 20 normal prepubertal children as controls. In 24 urine samples, RIA of 17-OHP was performed with and without column chromatography. RESULTS: There was a good correlation between 24-hour urinary 17-OHP and 24-hour urinary pregnanetriol (r = 0.962, P < 0.01) and between 24-hour urinary 17-OHP and morning serum 17-OHP (r = 0.955, P < 0.01). There was no significant difference in the RIA of the urine samples with and without purification by column chromatography. CONCLUSIONS: The measurement of 24-hour urinary 17-OHP is a reliable alternative for the biochemical monitoring of 21-OHD, and RIA specificity is unaffected by omission of column chromatography.

17-alpha-Hydroxyprogesterone↗
PubMed1988

Effect of pinealectomy on testosterone, estradiol-17 beta, esterone, and 17 alpha-hydroxyprogesterone levels during the annual reproductive cycle in the freshwater catfish, Clarias batrachus.

The present study examines the relationship of the pineal gland to gonadal activity during the annual reproductive cycle in the freshwater catfish Clarias batrachus. The hormonal profiles of testosterone, estradiol-17 beta, estrone, and 17 alpha-hydroxyprogesterone along with the gonadosomatic index (GSI) were monitored to assess the effect of pinealectomy. Pinealectomy appeared to accelerate the gonadal development from January to May. Removal of pineal prior to the start of gonadal recrudescence (January and February), induced initiation of ovarian recrudescence earlier than scheduled in nature. On the other hand pinealectomy during the vitellogenic phase (May to June) reduced the gonadal activity, suggesting the stimulatory role of pineal on gonads. During the remaining period of July to December (postvitellogenic and early resting phase) pinealectomy had no effect on gonadal activity. Thus, in this species the pineal gland during the annual reproductive cycle appears to have either inhibitory, stimulatory, or no effect on gonadal physiology depending upon the sexual conditions.

17-alpha-Hydroxyprogesterone↗
PubMed1988

Neonatal screening for congenital adrenal hyperplasia using 17-hydroxyprogesterone assay in filter paper blood spots.

Screening of infants for congenital adrenal hyperplasia (CAH) using filter paper blood samples collected on the 5th day of life was performed with a radioimmunoassay for 17-hydroxyprogesterone without extraction with organic solvents. A total of 153,000 newborns were screened and 12 cases of CAH were detected (1:12,800). With recall levels related to gestational age, the recall rate could be lowered to 0.05%.

17-alpha-Hydroxyprogesterone↗
PubMed1988

Analysis of blood spot 17 alpha-hydroxyprogesterone concentration in neonates.

Blood spot 17 alpha-hydroxyprogesterone (17-OHP) concentrations were measured in 515 infants aged from the 4th to the 81st day of life, using a fluorescence enzyme immunoassay method, and the values obtained were analyzed with respect to birth weight, gestational age at birth and sampling age, to obtain accurate reference ranges and to decide appropriate cut-off limits in a neonatal mass screening for steroid 21-hydroxylase deficiency. The results obtained indicate that the blood spot 17-OHP values in neonates should be interpreted using several different reference ranges obtained on the basis of the equivalent age of gestation at blood sampling. In the mass screening, therefore, the cut-off limits for recall are decided by these reference ranges as follows: (1) for blood resampling, 120, 30 and 25 nmol/l for the equivalent sampling ages of 31 weeks or less, 32-41 weeks and 42 weeks or more, respectively, and (2) for rapid confirmation of the disease by means of physical and laboratory examinations, 210, 60 and 60 nmol/l, respectively.

17-alpha-Hydroxyprogesterone↗