Isolated follicle-stimulating hormone deficiency in men: successful long-term gonadotropin therapy*

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1 FERTILITY AND STERILITY Copyright c 1984 The American Fertility Society Printed in U.SA. Isolated follicle-stimulating hormone deficiency in men: successful long-term gonadotropin therapy* Ahmed A.-K. AI-Ansari, M.B., BCh., M.Sc., Ph.D.t Taber H. Khalil,. M.B.,. B.S., M.D.t Yousuf Kelani, F.R.C.P. t Christopher H. Mortimer, M.B., M.R.C.P.t Sabah Hospital, Ministry of Public Health, Kuwait, Arabian Gulf, and London, England Two men with primary infertility after 6 to 11 years of marriage were found to have isolated follicle-stimulating hormone deficiency syndrome (lfds). Their endogenous gonadotropin secretion was compared with that of two other infertile men with hypothalamic disease (Kallmann's syndrome) and pituitary tumor with hyperprolactinemia. Treatment with intramuscular gonadotropin was given to produce circulating and 24-hour urine levels of luteinizing hormone and folliclestimulating hormone at or. above the upper limit of the normal male range to ensure continued gonadal stimulation. Sperm counts increased in IFDS men within 6 to 26 weeks, with maximum total sperm counts of 33.5 and20 million after 9 to 80 weeks. Pregnancy occurred after 20 weeks'therapy in one patient's wife with the subsequent delivery of a normal male infant. IFDS may be a treatable cause of male infertility given adequate gonadotropin therapy. FertilSteril42:618,1984 The deficiency of both luteinizing hormone (LH) and follicle-stimulating hormone (FSH) as a result of hypothalamic or pituitary disease causing male infertility is a well-recognized condition. Such patients commonly present with failure of potency and the clinical features of hypogonadism. Potency and spermatogenesis can be restored by thelong-term administration of intramuscular (1M) gonadotropins!' 2 or subcutaneous gonadotropin-releasing hormone (GnRH) therapy.3 Patients with LH deficiency, "fertile eunuch" syndrome, and decreased androgen levels but nor- Received November 16, 1982; revised and accepted June 1, *Supported by the Medical Research Board, Ministry of Public Health, Kuwait. tendocrinology Unit and Hormone Laboratory,Sabah Hospital, Ministry of Public Health, Kuwait. :f:reprint requests: Dr. C. H. Mortimer, Consultant Endocrinologist, 144 Harley Street, London WIN lah, England. 618 AI-Ansari et ai. IFDS: gonadotropin therapy mal FSH levels are readily identified from their clinical presentation. Mortimer and Besser 4 (1976) and Mortimer 5 (1977) described three male patients with a less clinically obvious cause for their infertility. All were normally virilized, with normal potency, and normal LH and testosterone (T) levels, but with oligospermia or azoospermia and a reduction in spermatogonia and maturation arrest on testicular biopsy. In men with normal hypothalamic-pituitary function the occurrence of primary testicular disease resulting in oligospermia or azoospermia normally results in the elevation of basal FSH levels and an exaggerated response to GnRH.6 However, in the three patients described, the basal FSH levels were undetectable or within the normal range for a normal adult male with a normal sperm count. The FSH levels therefore were considered to be inappropriate; and in view of the otherwise normal hormonal findings, it was proposed that these patients had the isolated FSH deficiency syn-

2 drome (lfds). Treatment with subcutaneous GnRH was given with an increase in total sperm counts in two patients, although the third, despite a clear increase in circulating serum FSH over 8 months, remained azoospermic. No pregnancies resulted. It was proposed that the capacity of the pituitary gland to secrete sufficient FSH for fertility was inadequate. It was our intention in the present study to compare endogenous gonadotropin levels in IFDS patients and other infertile men (hypothalamic dysfunction, Kallmann's syndrome, pituitary tumor with hyperprolactinemia) with normal men and to administer 1M sufficient gonadotropin to the patients to ensure long-term gonadal stimulation. The results and implications of such treatment are discussed. PATIENTS MATERIALS AND METHODS Kallmann's Syndrome ("Isolated Gonadotropin Deficiency") A male patient, 40 years of age, presented with mild diabetes mellitus treated with glibenclamide, primary infertility after 5 years of marriage with azoospermia, reduced potency, reduced beard growth, and hyposmia. He. was of eunuchoid proportions, with facial asymmetry and gynecomastia. The testes were soft in consistency, with a volume of 2 to 4 ml (normal, 10 to 25), but otherwise normal. The basal serum LH was 3.3 Ull (normal, 1.4 to 9.7 VIl) and the FSH level was 0.3 Ull (normal, 1.0 to 7.0 VIl). There was an impaired LH response to 100 ILg GnRH intravenously but a normal FSH response. There was no significant change in serum gonadotropin levels during a standard clomiphene test (3 mglkg body weight) over 10 days. The remaining endocrine function, karyotype, and skull x ray were normal. There was parental consanguinity (cousins). Pituitary Tumor A male patient, 42 years of age, presented with primary infertility after 15 years of marriage following partial hypophysectomy for a pituitary tumor with azoospermia, reduced potency, reduced beard growth, and hypothyroidism. The testes were soft in consistency, with a volume of 10 to 12 ml, but otherwise normal. The basal serum LH was low (0.8 VIl) and the FSH level was normal (1.1 V/l). There was an impaired serum LH but normal FSH response to 100 ILg GnRH given intravenously. There was no significant change in serum gonadotropin levels during a standard clomiphene stimulation test. Basal serum prolactin (PRL) levels were between 2400 and> 4000 mull (normal, up to 360 mull) with an absent cortisol and growth hormone response during an insulin tolerance test despite adequate hypoglycemia. The patient received 20 mg oral hydrocortisone on waking and 10 mg at 7:00 P.M. and thyroxine, 0.2 mg daily. He had a normal male karyotype. A skull x-ray showed an enlarged pituitary fossa. The patient had reduced visual fields on formal testing. There was no parental consanguinity. IFDS Two normally virilized male patients with normal potency, 30 and 37 years of age, of normal male habitus and normal sense of smell, presented with primary infertility after 6 and 11 years of marriage, with maximum total sperm counts prior to treatment of 0.6 to 1. 7 million (normal, > 80 million), motility of 0% to 30% (normal, > 60%) in seminal volumes of 1.5 to 4.0 ml (normal, 1 to 5 mi). The testes were of normal or soft consistency, with a volume of 11 to 20 ml, with no evidence of epididymal dilatation, varicocele, etc. Basal serum LH levels were within the normal male range (8.1 and 5.7 UIl), with a normal response to 100 ILg GnRH given intravenously. Basal serum FSH levels were < 0.5 and 3.0 VII, remaining undetectable in one patient, while rising to 5.3 VII at 20 minutes and 60 minutes in the other patient following 100 ILg GnRH given intravenously. During a clomiphene stimulation test, serum FSH levels rose from < 0.5 to 0.9 UII in one patient and from 3.0 to 5.6 VII in the other patient. In both, serum LH levels rose to above the upper limit of the normal basal range to 11.5 and 28.2 Vil. The thyroid-stimulating hormone responses to thyrotropin-releasing hormone, 200 ILg given intravenously, were normal. Both patients had normal thyroid function with normal basal PRL levels of 200 and 230 mull and normal cortisol and growth hormone responses during an insulin tolerance test. There was no history of parental consanguinity in either of the patients. Both patients had normal male karyotypes. The x-rays of AI-Ansari et al. IFDS: gonadotropin therapy 619

3 the skull were normal, and the pituitary fossae were not enlarged. The visual fields were normal. Testicular Biopsy in IFDS Patient 1 The seminiferous tubules were just within the normal range of size, with an average diameter of 125 f1 (normal, 120 to 200 f1), but only 15% produced spermatozoa. The rest of the tubules were empty and lined by Sertoli cells only. The Johnsen mean score was 3.9. The Leydig cells were prominent in the interstitial tissue, with occasional groups of chronic inflammatory cells, but no fibrosis. The overall picture was of severe hypospermatogenesis. Testicular Biopsy in IFDS Patient 2 The biopsy showed evidence of sloughing, with the seminiferous tubules filled with desquamated immature cells, although 90% of the tubules contained some mature spermatozoa. The Johnsen mean score was 8.3. The Leydig cells appeared normal. The overall picture was of disordered spermatogenesis. Additional Investigations None ofthe four patients had a history of orchitis or venereal disease, and all had been off hormonal treatment for a minimum of 2 months prior to 1M gonadotropin treatment apart from the pituitary tumor patient, who continued to receive hydrocortisone and thyroxine replacement. Serum sperm antibodies were negative prior to treatment in all patients, and all semen samples were negative on culture. All had normal routine hematology, biochemistry, urinalysis, renal function, and creatinine clearance. INVESTIGATION PROTOCOL Following initial clinical endocrine assessment and basal seminal analysis, each patient proceeded thus: Day -13 Admission to the Endocrinology Unit. Intravenous heparinized cannula inserted at 7:00 A.M. with the patient fasting and at rest. Blood samples were withdrawn at 8:00 A.M., time 0, then at 6,12, and 24 hours, for hematology, biochemistry, and hormonal determinations; and a 24-hour urine sample was collected. 620 AI-Ansari et al. IFDS: gonadotropin therapy Day -12 The procedure was the same as for day -13, except that at time 0, 4 ampules of human menopausal gonadotropin (hmg) (Pergonal, Serono Laboratories Ltd., Welwyn Garden City, England), dissolved in 1 ml of normal saline (equivalent to 300 IU LH, 300 IU FSH), were given by 1M injection 1 inch below the iliac crest. Day -3 The patients were asked to abstain from sexual intercourse. Day 0 The procedure was the same as for day - 13 except that at time 0, 500 IU human chorionic gonadotropin (hcg) (Profasi, Serono Laboratories Ltd.), dissolved in 1 ml of normal saline, was given by 1M injection 1 inch below the iliac crest, and seminal analysis was repeated. ASSAYS The gonadotropins were measured by doubleantibody radioimmunoassay (RIA), and the results were expressed as LH Medical Research Council (MRC) 68/40 antiserum F87 and FSH MRC 78/549 antiserum M93. RIA of PRL was performed using a specific antiserum and standardized against MRC 75/504. Plasma cortisol was measured by an RIA using 1251-labeled hormone; 17 a-hydroxyprogesterone (17 -OHP), androstenedione (11 4 A), dehydroepiandrosterone (DHEA), estrone (E1), estradiol (E2), and dihydrotestosterone (DHT) were determined following extraction using tritium-labeled hormone. Plasma T was measured after extraction using 1251 label and sex-hormone-binding globulin (SHBG) by a modification of Rosner's method using tritiated DHT as ligand. 7 RESULTS Basal Steroid, SHBG, and PRL Levels (Table 1) In the patients with Kallmann's syndrome and pituitary tumor, basal androgen levels were reduced. SHBG was reduced in the pituitary tumor patient, and serum PRL was elevated at 2400 mull. The two patients with IFDS had normal plasma T, 17-0HP, 1l 4 A, and DHEA levels, although both

4 Table 1. Circulating Steroid, SHBG, and PRL Levels Basally and During Gonadotropin Therapy Patient T DHT 17-0HP d 4 A DHEA E, E. SHBG PRL nmolll nmolll nmolll nmolll ij.molil pmolll pmolll nmolll mull Kallmann's syndrome Basal levels 1.8a 0.3a a < 1a Maximum during long- M5 M5 M5 MIO M6 M4 M2 M2 M4 term therapy (M)b l.5a 9.2a a 1911a 63a 400a Minimum during long- M4 M1,2 M1 M8 M8 M1 M12 M3 M7 term therapy (M) < 5a 0.2a a 1.1a < loa 210 Pituitary tumor Basal levels 1.06a 0.3a 0.2a 1.7a 0.2a a < loa 2400a Maximum during long- M7 M3 M3 M4 M3 M3 M3 M3 term therapy (M) 4.5a a 654a 654a 33 > 4000a Minimum during long- M2 M5 M5 M2 M1 M6 M6 M1 term therapy (M) 1.2a 0.5a < O.la 0.9a O.la < loa > 4000a IFDS (1) Basal levels a a 12a 200 Maximum during long- M5 M6 M7 M6 M7 M3 M1 M1 M1 term therapy (M) a a a 891a a Minimum during long- M2 M3 M6 M1 M6 M4 M5 M3 M4 term therapy (M) a < loa 120 IFDS (2) Basal levels a Maximum during long-, M3 M3 M4 M2 M2 M2 M3 M4 M1 term therapy (M) a ~ 1990a 1385a 66a 390a Minimum during long- M1 M1 Mll M3 M6 M8 M8 M1 M3 term therapy (M) a a 220 Normal basal male < < 360 range a Abnormal level. bm, month of maximum or minimum assay level during long-term gonadotropin therapy. had reduced DHT levels (0.5 and 0.3 nmolll [normal, 0.7 to 2.7 nmolll]) and one had a reduced SHBG level. The plasma E2 level was raised in one patient at 213 pmolll (normal, < 200 pmolll). Serum and Urinary Gonadotropin Levels Basally and After hmg, 4 ampules 1M, or heg, 500lU 1M (Figs. 1 and 2) In each patient, after hmg (4 ampules 1M) serum LH and FSH rose, reaching peak levels after 6 to 12 hours, and remained elevated for 24 hours (Fig. 1). After hcg (500 IU 1M) serum "LH" (representing known cross-reaction within the assay) also rose to peak levels at 6 to 12 hours and remained elevated at 24 hours. In the patients with Kallmann's syndrome and pituitary tumor, an increase in serum FSH-like material was noted at 6 and 12 hours following injection. In the patients with Kallmann's syndrome and pituitary tumor, basal 24-hour urine LH levels were reduced, although these were within the normal range in both patients with IFDS at 28 Ul24 hours (Fig. 2) and 47 Ul24 hours (normal, 21.4 to 53.2 Ul24 hours). Following hmg, urine LH levels rose to within the normal range in both the Kallmann's syndrome and pituitary tumor patients and increased in both IFDS patients to 41 U!24 hours and 62 Ul24 hours. hcg also produced an increase in urinary "LH" to within the normal male range in all patients and in IFDS to 38 U!24 hours and 74 Ul24 hours. Basal 24-hour urine FSH levels were at the lower limit of the normal range in the patient with Kallmann's syndrome, 8 U!24 hours (normal, 8.0 to 18.3 Ul24 hours), clearly low in the pituitary tumor patient, and toward the lower end of the normal range in the two IFDS patients at 11 and 12 U!24 hours. Following hmg, FSH levels rose to within or above the normal range in all subjects and to 20 Ul24 hours in one IFDS patient and 32 Ul24 hours in the other patient. Following hcg there was no increase in FSH-like material in the urine of either the Kallmann's syndrome or the pituitary tumor patient. The serum and urine gonadotropin levels achieved in this part of the study were taken to represent the maximum values likely to occur during long-term therapy. AI-Ansari et ai. IFDS: gonadotropin therapy 621

5 22.7 l SPERM 0 SPERM 0 15 ~ t Kallmann's Pituitary g Syndrome SERUM 10 lh ~ (U/l) 5 I,, SERUM NO.... I 10 FSH 5 lull.) NO ~ ~ o o TIME HOURS g Figure. I I I o Serum gonadotropin levels basally (0) and following Pergonal, 4 ampules (e), or hcg, 500 IU (.. ) 1M. Treatment Protocol Following the results of the above investigations, it was decided to treat the patients as follows: Saturday hmg, 4 ampules 1M, and heg, 500 IU 1M; Monday hmg, 4 ampules 1M; Wednesday hmg,' 4 ampules 1M, and heg, 500 IU 1M. The 4 ampules of hmg were dissolved in 1 ml of normal saline, as was the heg, although these were always given by separate injection in different syringes. Serum and Urinary Gonadotropin Levels During Long-Term hmg Therapy Serum samples were collected each Saturday at 9:00 to 10:00 A.M. prior to the 1M injections of hmg and heg. The 24-hour urine samples were collected from 9:00 A.M. on Friday to 9:00 A.M. on Saturday. In each patient except the pituitary tumor patient, serum LH and FSH levels were recorded within the normal male range at 1 month on treatment. In this patient, although LH Kallmann's Syndrome Pituitary Tumor IFSH Deficiency URINE LH lu/24hrs) URINE FSH IU/24hrs) Figure 2 Urine gonadotropin levels basally (B) and following Pergonal, 4 ampules (Pl, or hcg, 500 IU (H) 1M. 622 AI-Ansari et al, IFDS: gonadotropin therapy

6 MALE WITH ISOLATED FSH DEFICIENCY 0.9xl0 WIFE PREGNANT 1.lxl0 14.4xl0 SPERM COUNT I 33.5xl0 9.45xl (:L:~I~L~ =~t _ PLASMA 2000 [ E (pmol/l) NO ~ ~~~~t~ ~~ t r- j 1?i ; : :,:,: : t: : : /: : : : : : : : :V:':':':':l o MONTHS OF TREATMENT Figure 3 IFDS patient 1: plasma T, E 2, and SHBG levels and total sperm counts during long-term hmg and hcg therapy. levels rose into the normal range, serum FSH was undetectable at 1 month. Subsequently, during treatment serum gonadotropin levels were maintained within the normal male range in all patients. The urine gonadotropin levels during longterm therapy ranged as follows: urine LH (U/24 hours): Kallmann's syndrome, 32 to 78; pituitary tumor, 14 to 30; IFDS, 26 to 42 (normal basal male range, 21.4 to 53.2). Urine FSH (U/24 hours): Kallmann's syndrome, 11 to 54; pituitary tumor, 10 to 14; IFDS, 11 to 32 (normal basal male range, 8.0 to 18.3). The serum and urine gonadotropin levels achieved in this part of the study were taken to represent the minimum values likely to occur during long-term therapy. mained azoospermic, with raised serum PRL levels during treatment at> 4000 mull (normal, up to 360 mull) and a reduced plasma T level between 1.2 and 4.5 nmol/l (normal, 8.7 to 41.7 nmol/l). After 8 months the patient's gonadotropin therapy was stopped, and he was started on bromocriptine, increasing to 5 mg every 8 hours and Sustanon 250 (Organon Laboratories, Ltd., Cambridge, England) 1M every 15 days. This resulted in suppression of serum PRL levels to within the normal range and restoration of potency. Seminal analysis carried out on this treatment 1 month after stopping gonadotropin therapy showed a total sperm count of 10 million with 35% motility, 22% abnormal forms, in a volume of 1 ml. In IFDS patient 1 (Fig. 3) the total sperm count rose to 14.4 million after 6 weeks. Motility was 55%, in a volume of 4.5 ml. After 10 weeks this increased to a total count of 33.5 million, 55% motility, in a volume of 5 ml. At 5 months the patient's wife became pregnant, at which time the total sperm count was 9.45 million, motility 55%, in a volume of 3.5 ml. During treatment, up to 35% abnormal forms were recorded. The patient's wife delivered a normal male infant. In IFDS patient 2 (Fig. 4) the total sperm count rose to 5 million, with 30% motility, after 6 months, in a volume of 2.5 ml. After 11 months the total sperm count had increased to 6 million, with 40% motility in a volume of 2 ml. After 20 months of treatment the total count reached 20 million, with 60% motility in a volume of 2 ml. During treatment, up to 30% abnormal forms were recorded. Circulating Steroid, SHBG, and PRL Levels and Sperm Counts During Long-Term hmg and hcg Therapy (Table 1 and Figs. 3 and 4) During therapy blood. samples and semen (after a minimum of 3 days of sexual abstinence) were collected at monthly intervals. The basal values and the minimum and maximum levels of the variables achieved during treatment for each patient are shown in Table 1. The Kallmann's syndrome patient remained azoospermic during therapy until the seventh month, when a few sperm were seen in the ejaculate. After 18 months the total sperm count increased to 4 million, with 50% motility in a volume of 2 ml. The pituitary tumor patient re- MALE WITH ISOLA TED FSH DEFICIENCY SPERM COUNT < PLASMA T 40[ 20 (nmol/l) NO PLASMA 2000 [ E lpmol/l\ NO PLASMA 80 f SHBG 40 \nmol/l) NO,..;;:..**.0"$... p;... ;,... j, I-' o MONTHS OF TREATMENT Figure 4 IFDS patient 2: plasma T, E 2, and SHBG levels and total sperm counts during long-term hmg and hcg therapy. AI-Ansari et al. IFDS: gonadotropin therapy 623

7 DISCUSSION The occurrence of oligospermia or azoospermia with maturation arrest of spermatozoa, normal T and normal serum LH levels in the presence of undetectable or inappropriately low basal serum FSH levels, but with otherwise normal pituitary function, constitute the essential features of the IFDS in men. The LH response to GnRH is normal, whereas that of FSH may be absent or impaired but not exaggerated, as would be expected in patients with oligospermia or azoospermia due to primary testicular disease. This implies that in such patients there is a deficiency in an FSH-releasing hormone (for which no evidence exists in the human), an increase in a hypothalamic FSH inhibitory factor, a defect in pituitary gland FSH synthesis or release, the secretion of an immunologically active but biologically inactive form of FSH as reported previously for LH, 8 or that the necessary testicular receptor sites are blocked, resistant, or otherwise not available. Previous treatment of such patients with the subcutaneous administration of GnRH increased spermatogenesis, although no pregnancies were recorded despite continued FSH secretion. In patients with more limited capacity for FSH secretion, spermatogenesis may not occur because of a simple lack of hormone even if that which is secreted is potentially biologically active. In the present study, it was our intention to provide a dose of 1M gonadotropin to maintain circulating and urinary LH and FSH levels at or above the upper limit of the normal male range in patients with IFDS using readily available preparations of known biologic activity. In one IFDS patient there was a clear increase in spermatogenesis from pretreatment total sperm counts of 0.9, 1.1, and 1.7 to 14.4 million at 6 weeks, although the normal time to complete the spermatogenic process is generally taken as 12 weeks. This implies that spermatogenesis had been arrested at a later stage than in the other patient, in whom an increase in the total sperm count was not seen until 26 weeks or until 28 weeks in the patient with Kallmann's syndrome. The time taken for spermatogenesis to occur in the patient with the pituitary tumor and hyperprolactinemia was uncertain in view of his continued impotence, although the process was clearly continuing despite reduced plasma T levels. When potency was 624 AI-Ansari et al. IFDS: gonadotropin therapy restored by 1M T, the first ejaculate contained 10 million sperm. It was noted previously that it is not necessary to achieve normal plasma T levels for spermatogenesis to occur.3 In the pituitary tumor patient, unlike the others, 1M gonadotropin therapy failed to bring the plasma T level into the normal range. However, he was the only patient with elevated serum PRL levels, and this may account in part for the gonadal resistance to the dose of gonadotropin used. In the IFDS patients it was particularly encouraging that spermatogenesis occurred with the unpromising histologic features seen on testicular biopsy. In the patient who produced a pregnancy, only 15% of the tubules were producing spermatozoa; the rest of the tubules were empty and lined only by Sertoli cells. In the other patient there was evidence of sloughing in the seminiferous tubules, but spermatogenesis was still initiated, although it was not until after 80 weeks of treatment that a total sperm count of 20 million was achieved. It would appear that the advantage that IFDS patients have in maintaining the potential for spermatogenesis is normal LH levels and the production of intratesticular T, although in both the patients in this study plasma DHT concentrations were reduced prior to therapy. The role of reduced circulating FSH levels in this finding is uncertain. The use of the standard preparations of gonadotropins currently available (75 IV LH and 75 IV FSH in each ampule) for the treatment of male (and female) infertility, although successful in certain cases, may prove not to be the optimal balance of hormone. The availability of FSH separately may allow gonadal steroidogenesis to be induced with heg alone, monitoring the response to treatment by the measurement of gonadal steroids and titrating the dose of FSH against the sperm counts. It may be that in the initial phases, circulating and urinary FSH levels will need to be maintained at many times those found in normally fertile men in order to promote effective spermatogenesis in testes devoid of adequate FSH stimulation over many years. For patients in whom spermatogenesis has been successfully achieved, it is possible in certain circumstances to maintain the sperm count to a potentially fertile level with heg only or possibly in combination with clomiphene. The finding in the present study of an increase in serum FSH-like material following heg in two patients may have been due to the

8 presence of this hormone in the preparation, although the presence of a gonadotropin-releasing factor cannot be entirely excluded. Any accompanying increase in pituitary LH secretion could not be identified in view of the known cross-reactivity ofhcg and LH. However, such a possibility could be tested in another animal species with endogenous pituitary hormones of different immunologic characteristics to human hcg. During treatment it was noted that circulating and urinary gonadotropin levels were maintained within the normal basal male range up to 3 days following 1M injection. This implies that a depotlike effect occurs, with the hormone gradually entering the circulation, providing continued gonadal stimulation on which are superimposed additional gonadotropin peaks at the time of the three times weekly injections. It was suggested previously9 that the pulsatility of pituitary gonadotropin secretion may be important in determining gonadal responsiveness, and the variable rise and fall in gonadotropin levels achieved during this treatment regimen may prove to be more effective than constantly maintained gonadotropin levels. In all the patients studied, there was a marked increase in plasma estrogens during therapy, with peak values of SHBG occurring at about the same time. However, despite additional LH stimulation in the two IFDS patients, plasma T levels remained within the normal basal range throughout. Although the increase in plasma estrogen levels, and presumably also intratesticular estrogen, did not appear to inhibit spermatogenesis, it would be of interest in further studies with separate LH (hcg) and FSH preparations to determine whether the maintenance of such levels within the normal basal range will achieve any advantages in the response to treatment. No patient reported any deterioration in libido during treatment, and gynecomastia was not detected in the three patients who were clinically normal before therapy. The gynecomastia present in the Kallmann's syndrome patient did not increase. During the study the results of the hormonal changes were compared with accepted normal ranges determined for British subjects. At the present time, normal ranges for patients of Arabic origin (Kuwaiti, IFDS and pituitary tumor; Jordanian, Kallmann's syndrome) do not exist. However, preliminary data suggest that both sex- es considered. to be normal in appearance by others of similar origin (of the same skin color, degree of facial and body hair growth) exhibit reduced SHBG levels, compared with British subjects. Whether this represents a clear ethnic difference in SHBG synthesis and what the effect is on free androgen levels and conversion to estrogen in such patients, compared with British patients, remains to be discovered. The incidence of IFDS as a cause for childlessness is uncertain at present, not least because of the otherwise normal physical appearance and sexual function of affected individuals. However, it is anticipated that this condition, with partial or complete FSH deficiency, does not represent a rare endocrine novelty but will prove to be rather common on wider screening. From the present limited study it is proposed that IFDS may be a treatable cause of male infertility, although the optimum dose levels of LH and FSH for the individual patient may require modification. Acknowledgments. We are grateful to Sisters Sarama and the ancillary staff and technicians of the Endocrinology Unit and Hormone Laboratory, Kuwait, for their active support throughout these studies. REFERENCES 1. Gemzell C, Kjessler B: Treatment of infertility after partial hypophysectomy with human pituitary gonadotrophins. Lancet 1:644, MacLeod J, Pazianos A, Ray BS: Restoration of human spermatogenesis by menopausal gonadotrophins. Lancet 1:1196, Mortimer CH, McNeilly AS, Murray MAF, Fisher RA, Besser GM: Gonadotrophin-releasing hormone therapy in hypogonadal males with hypothalamic or pituitary dysfunction. Br Med J 4:617, Mortimer CH, Besser GM: Gonadotrophin releasing hormone therapy in man. In Proceedings of the International Congress of Endocrinology Series No. 402,. Edited by VHT James. Hamburg, Excerpta Medica International, 1976, p Mortimer CH: Gonadotrophin releasing hormone. In Clinical Neuroendocrinology, Edited by L Martini, GM Besser. New York, Academic Press, 1977, p Mortimer CH, Besser GM, McNeilly AS, Marshall JC, Harsoulis P, Tunbridge WMG, Gomez Pan A, Hall R: Luteinizing hormone and follicle-stimulating hormonereleasing hormone test in patients with hypothalamic-pituitary-gonadal dysfunction. Br Med J 4:73, Rosner W: A simplified method for the quantitative determination oftestosterone-estradiol-binding globulin activity in human plasma. J Clin Endocrinol Metab 34:983, 1972 AI-Ansari et al. IFDS: gonadotropin therapy 625

9 8. Axelrod L, Neer RM, Kliman B: Hypogonadism in a male with immunologically active, biologically inactive luteinizing hormone: an exception to a venerable rule. J Clin Endocrinol Metab 48:279, Mortimer CH, Besser GM, Goldie DJ, Hook J, McNeilly AS: Asynchronous changes in circulating LH and FSH afterthe gonadotrophin releasing hormone. Nature (New BioD 246:22, AI-Ansari et al. IFDS: gonadotropin therapy

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