INTERMITTENT BROMOCRIPTINE TREATMENT FOR THE INDUCTION OF OVULATION IN HYPERPROLACTINEMIC PATIENTS*

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1 FERTILITY AND STERIUTY Copyright 979 The American Fertility Society Vol. 3, No.3, March 979 Printed in U.s A. INTERMITTENT BROMOCRIPTINE TREATMENT FOR THE INDUCTION OF OVULATION IN HYPERPROLACTINEMIC PATIENTS* HERJ'AN J. T. COELINGH BENNINK, M.D.t Department of Obstetrics and Gynecology, State University Hospital, Utrecht, The Netherlands Postovulatory treatment with bromocriptine bears a potential teratogenic risk. Therefore, after restoration of the menstrual cycle in 20 infertile hyperprolactinemic anovulatory patients, treatment was restricted to the follicular phase and the periovulatory period. The resulting intermittent treatment regimen using a dose of 5 mg of bromocriptinelday yielded ovulatory cycles in all 20 patients. Fifteen pregnancies were achieved in thirteen patients, two women becoming pregnant twice. Discontinuation of treatment after ovulation caused hyperprolactinemia during the luteal phase. This did not seem to interfere with the establishment and maintenance of pregnancy. Hyperprolactinemia during the follicular phase may be related to luteal insufficiency. Fertil Steril3:267, 979 Female infertility due to anovulation and accompanied by hyperprolactinemia and possibly galactorrhea can be treated successfully with bromocriptine. - 3 In these patients bromocriptine is superior to clomiphene or gonadotropins because there is a normal spontaneous abortion rate, a normal incidence of multiple pregnancy, absence of ovarian enlargement during treatment, a high pregnancy rate, and no need for expensive biochemical monitoring. 3, 4 However, one potential disadvantage exists_ Bomocriptine must be taken daily to restore the menstrual cycle. Cessation of therapy is followed by recurrence of amenorrhea and eventually galactorrhea. 5 Neither clomiphene nor gonadotropin treatment was given after ovulation. In pregnancies achieved during treatment with bromocriptine the patients take the drug dur- Received December 22, 977; revised March 2, 978, and October 23, 978; accepted November 2, 978. *Presented in part at the Ninth World Congress on Fertility and Sterility and the Thirty-Third Annual Meeting of The American Fertility Society, April 2 to 6, 977, Miami Beach, Fla. treprint requests: HeIjan J. T. Coelingh Bennink, M.D., Department of Obstetrics and Gynecology, State University Hospital, Catharijnesingel 0, Utrecht, The Netherlands. ing the earliest embryologic phase of pregnancy. Immediate cessation of medication when pregnancy is suspected has been advised, but even then the patient takes bromocriptine for at least 3 to 4 weeks after conception. Because most patients who are treated with this drug have either amenorrhea or oligomenorrhea, the diagnosis of pregnancy can easily be delayed for several months. Preliminary results have suggested that, in order to avoid post conceptional treatment, the administration of bromocriptine be restricted to the follicular phase and the peri ovulatory period with discontinuation of treatment after ovulation. 6 In this paper the efficacy of the resulting intermittent treatment regimen with bromocriptine is confirmed. Restoration of the menstrual cycle is demonstrated and pregnancy and abortion rates are shown. Prolactin, progesterone, and 7 {3-estradiol levels are studied during this regimen with special emphasis on the untreated luteal phase. MATERIALS AND METHODS Patients. Twenty hyperprolactinemic anovulatory patients who were infertile were selected for 267

2 268 COELINGH BENNINK March 979 TABLE. Characteristics of Twenty Hyperprolactinemic Anovulatory Patients Patient Age Obstetric history Gynecologic/endocrinologic history" Serum prolactin nglml A R -> G -> Ab -> OCA -> A + G 5.2 B R -> OCA -> A + G 20.0 C R -> 0 -> OCA -> A 87.5 D R->P->A+G 40.4 E R->P->A+G 74.8 F R -> OCA + G -> P -> A + G 55.0 G R->G->P->A+G 9.0 H R -> OCA -> A + G 50.2 I O->A 35.0 K O/A -> OCA -> A 33.4 L R->P->A+G 68.0 M o -> A -> Cl -> P -> A + G 26.8 N AnovulationiO R -> Ab -> OCA -> A + G 22.4 P R->A->Gon->P->A+G 8.2 Q O->A 22.3 R > OCA -> A 36.8 S R -> 0 -> OCA -> A + G 42. T O->A 30.0 U R->O->A 25.0 ar, regular menstrual cycles; 0, oligomenorrhea; A, amenorrhea; Ab, abortion; P, parturition; G, galactorrhea; OCA, oral contraceptive agents; Cl, clomiphene; Gon, gonadotropins. induction of ovulation with bromocriptine. The main characteristics of these patients are shown in Table. The mean age at the start of treatment was 28.3 years. Seven patients each had one child. The other 3 patients had no children. Galactorrhea was present in 2 patients. Nineteen patients had amenorrhea and one patient repeatedly had anovulatory cycles. The mean duration of amenorrhea was 56 months with a range of to years. Seven patients had postpartum galactorrheaamenorrhea syndrome. Eight patients had postpill amenorrhea syndrome, of whom five had galactorrhea. Four patients had had oligomenorrhea resulting in secondary amenorrhea. Enlargement of the sella turcica was found in three patients with postpill galactorrhea-amenorrhea. Suprasellar extension was excluded by an air encephalography and assessment of the visual fields. In all patients complete endocrinologic screening had excluded causes of anovulation other than hyperprolactinemia. The mean pretreatment prolactin concentration was 52.5 ng/ml, with a range of9 to 25 ng/ml. All patients were considered to be hypoestrogenic as demonstrated by low 24-hour estrogen excretion. Gonadotropin levels were measured at the time by a biologic assay of urine and were either normal or low. Progesterone withdrawal was tested in 3 patients, 7 of whom experienced bleeding. Previous efforts to induce ovulation had been made in 6 ofthe 20 patients. In 4 of 3 patients ovulation had been initially achieved with clomiphene, but all became clomiphene-negative later. Induction of ovulation with high doses of human gonadotropins had been occasionally successful in 4 of patients, but no pregnancies were achieved and moderate signs of overstimulation had been present in 5 patients (ovarian cysts). The Intermittent Treatment Regimen. Infertile hyperprolactinemic patients selected for treatment with bromocriptine were told to record their basal body temperatures (BBT) and to use mechanical methods of contraception from the day of treatment. The initial dose was 2.5 mg of bromocriptine/day for 2 weeks; thereafter the dose was increased to 5 mg/day, which was the standard dose used. Ovulation was confirmed by BBT, serum progesterone, and endometrial biopsy. Follow-up visits were scheduled at 2-week intervals and included prolactin, progesterone, and 7 f3-estradiol assays. After the first menstrual period, contraception was discontinued. As soon as the patient observed a rise in BBT, she stopped the medication. If the BBT remained high, a pregnancy test was performed at the appropriate time, but if menstruation occurred bromocriptine treatment was started again immediately, the dose being 5 mg/day until the next rise in BBT. Using this regimen, treatment was restricted to

3 ~---- Vol. 3, No.3 INDUCTION OF OVULATION WITH BROMOCRIPTINE IN HYPERPROLACTINEMIA 269 bromoc,..:.'i.:;.;pt.;..;in..;,.e ----, ~ Smg BBT pregnancy menstruation D o D... contraception time (weeks) x x+2 x+4 x+6 x+8 x+io x+2 x+4 x+6 FIG.. The intermittent treatment regimen. the follicular phase and the periovulatory period (Fig..). If conception did not occur at the first six ovulations, postcoital tests and hysterosalpingography were performed (a semen analysis had been performed before the start of treatment). In the absence of other abnormalities interfering with fertility, bromocriptine treatment was extended to the luteal phase. After 2 ovulations laparoscopy was performed and, if normal, intermittent treatment was restarted. Prolactin, Progesterone, and 7f3-Estradiol. All blood samples were obtained in the afternoon. The three hormones were measured in duplicate by a homologous radioimmunoassay method. The intra- and interassay coefficients of variation were as follows: prolactin, 7% and %; progesterone, 0% and %; and 7,8-estradiol,.5% and 9.5%. All three assays were tested in healthy, fertile, ovulatory women. Normal levels in our laboratory are as follows: prolactin, less than 5 ng/ml; progesterone, 5 to 20 ng/ml (luteal phase); and 7,8- estradiol, 00 to 200 pg/ml (luteal phase). In one patient (patient H), a luteal phase after postovulatory discontinuation ofbromocriptine was studied more extensively by serial estimation of prolactin, progesterone, and 7,8-estradiol levels until the following menstrual period. RESULTS Menstrual Cycles. During treatment with bromocriptine, repeated ovulations were achieved in all 20 patients. The mean time to the first ovulation was 25 days with a range of to 67 days. The mean time to the first menstrual period was 39 days with a range of 2 to 8 days. Most patients ovulated regularly during intermittent treatment as shown by 63 ovulatory cycles with a mean cycle length of 3 days. Four of six originally oligomenorrheic patients became oligomenorrheic again (on both intermittent and continuous treatment). In one patient (patient P), anovulation and/or insufficiency of the luteal phase occurred during intermittent treatment. Pregnancies after Intermittent Treatment. The results of treatment are shown in Table 2. Of 5 pregnancies achieved in 3 patients by intermittent treatment, 3 occurred within 4 months. In TABLE 2. Results of Bromocriptine Treatment in Twenty Hyperprolactinemic Anovulatory Patients Patient Ovulation at which conception occurred Postovulatory treatment after conception Results of pregnancies Remarks days A B C D E F G H I K and 4th 2nd 2nd 2nd 9th 3rd 3rd and 6th L M 8th N 4th 0 and 3rd P Q R S T U 7th and 8th 8th 2; ; 8 2 2;- 24;26 6 Both healthy neonates Early abortion Early abortion. Late abortion Early abortion Healthy pair of twins Macroadenoma Macroadenoma Macroadenoma Spontaneous second pregnancy Discontinuation of therapy Husband has subfertile semen

4 270 COELINGH BENNINK March 979 cases bromocriptine treatment was stopped by the patient during the first 3 days after commencement of the BBT rise. They represent the ideal of intermittent treatment. Of these, one pregnancy ended in early abortion and the patient did not become pregnant again. In four cases bromocriptine was discontinued between the 8th and 2th days after the midcycle temperature minimum. The BBT charts of these four patients showed a slowly rising temperature and they were advised to stop treatment at the time of the control visit. Of these four patients, one had an early abortion. She again became pregnant on intermittent treatment. The second time she discontinued treatment on the day of the temperature rise. Thirteen healthy neonates have been delivered. Failures. Seven patients did not become pregnant during the intermittent regimen. In two cases a male factor was present (patients Rand S). Two other patients (patients T and U) also did not conceive during continuous treatment, but three patients did become pregnant. In the first patient (patient 0) this happened inadvertently because of failure ofthe initial contraception. She missed one follow-up visit and came later with a BBT chart indicating 3 weeks of hyperthermia. She had a positive pregnancy test, and bromocriptine was discontinued. This pregnancy resulted in a late abortion at 22 weeks' gestation. The second patient (patient P) showed short luteal phase hyperthermia during intermittent treatment (less than 0 days). An endometrial biopsy on the day of the menstrual period twice revealed proliferative endometrium, in spite of a biphasic BBT. Retrospective analysis showed that, during several follicular phases of six intermittent treatment cycles, she had remained slightly hyperprolactinemic. During continuous treatment, normal prolactin levels were achieved and she became pregnant twice. The first pregnancy resulted in an early abortion, the second in the birth of healthy twins. The third patient (patient Q) had oligomenorrheic menstrual cycles during intermittent and continuous treatment. She became pregnant at the second ovulation after initiation of continuous treatment. Other Aspects of Treatment. Galactorrhea was present in 2 patients and was completely suppressed in 0 patients. It recurred in reduced amounts in two patients during untreated luteal phases. All patients who became pregnant were followed carefully for signs of (further) sellar enlargement by sellar x-rays, assessment of the visual fields, and pituitary function tests. During pregnancy, no pituitary problems were encountered even in the four pregnancies in three patients with macroadenomas. The main side effects ofbromocriptine are nausea, postural hypotension, and (to a lesser degree) constipation and nasal congestion. During intermittent treatment some patients noticed slight nausea during the first days of each treatment course. This was never a reason to abandon the intermittent regimen. Prolactin, Progesterone, and 7f3-Estradiol. Follicular phase hyperprolactinemia was suppressed by 5 mg of bromocriptine/day in most patients, as shown by normal prolactin levels (below 5 ng/ml) between day 5 and day 2 ofthe menstrual cycle in 7 patients. One patient (patient P) repeatedly had hyperprolactinemia during the follicular phase in spite oftreatment (between 7 and 46 ng/ml). With continuous treatment she became normoprolactinemic and pregnant. Two other patients (patients A and B) were still hyperprolactinemic some days before conception occurred (4 and 36 ng/ml, 90 sol 70 I J : prol;).ctin ng/ml L_,_,_,_,_, progesterone ng/ml FIG. 2. Prolactin and progesterone levels between day 3 and day 0 during 43 hyperprolactinemic luteal phases of 9 patients treated intermittently with bromocriptine (0, conception occurred during this cycle).

5 Vol. 3, No.3 INDUCTION OF OVULATION WITH BROMOCRIPTINE IN HYPERPROLACTINEMIA 27 7)3- estradiol 300- pq/ml IOp-ro-l-a c-t i~ ng /ml I I progesterone ng/ml SJsJ J LJ,J 20LJ J 90Lol J solol J 3J,J J 0 o - LL~~,_,_,_,_ -2 -S -4 0 menstruation FIG. 3. Prolactin, progesterone, and 7 f3-estradiollevels during a luteal phase after discontinuation of bromocriptine treatment. respectively). Both patients had macroadenomas. One patient (patient 0) became pregnant without treatment after a late abortion in spite of persisting hyperprolactinemia (33 ng/ml). After discontinuation ofbromocriptine treatment a rapid recurrence of hyperprolactinemia was observed during the untreated luteal phase. The relationship between progesterone and prolactin levels during 43 hyperprolactinemic luteal phases is shown in Figure 2. High progesterone levels were usually found between day 3 and day 0 ofthe luteal phase in spite of hyper pro lactinemia. No difference was observed between progesterone and prolactin levels during 0 luteal phases after conception and 33 luteal phases followed by menstruation. One patient (patient H) who later became pregnant during intermittent treatment was studied more extensively (Fig. 3). Progesterone, 7(3- estradiol, and prolactin levels were estimated every 2 or 3 days from the day of the BBT rise until the following menstrual period. The prolactin level rose steadily from 22 to 86 ng/ml. Progesterone and 7 (3-estradiollevels were adequate, suggesting normal luteal function. DISCUSSION In man and in animals no specific teratogenic effects of bromocriptine have been reported. Congenital malformations were seen in infants of 369 pregnancies resulting in 375 live births (6 twin births) during which bromocriptine was given. 4 The mean duration of bromocriptine administration after conception was 27.4 days. No specific pattern of malformations was observed. This 2.9% frequency of congenital malformations is comparable to a frequency of 2.7% spontaneous malformations for a total of over 600,000 control patients. 7 These figures suggest that bromocriptine does not cause congenital malformations. However, as a general rule, the use of postovulatory drugs in pati~nts seeking pregnancy must be avoided as much as possible. The reports of intrauterine induction of vaginal adenosis and adenocarcinoma by diethylstilbestrol stress the importance of this principle and underscore the possibility of delayed side effects of drugs on the human fetus.s The intermittent regimen described in this paper has the advantage that post ovulatory treatment with bromocriptine is limited as much as possible. The main goal of this regimen is to induce ovulation, and the main question is whether this type of treatment is as effective as treatment until the first missed menstrual period or until a positive pregnancy test is obtained. During intermittent treatment, 5 pregnancies were achieved by 3 patients, proving that pregnancies can be established by this regimen. Two abortions occurred, but thirteen pregnancies progressed without problems, which seems an acceptable percentage. Restoration of the menstrual cycle was successful in all 20 patients. occurred only in patients who were oligomenorrheic before the onset of amenorrhea. did not improve if intermittent treatment was replaced by continuous treatment. Rapidly recurring byperprolactinemia during the luteal phase need not be a barrier to adequate luteal function as was demonstrated by the high rate of conception and the large proportion of successful pregnancies. In cycles without conception luteal function was not tested in detail, but single serum progesterone estimations were usually within the normal midluteal range in spite of hyperprolactinemia. Several reports in the literature suggest a relationship between hyperprolactinemia and luteal insufficiency, but they do not distinguish between

6 272 COELINGH BENNINK March 979 follicular phase and luteal phase hyperprolactinemia. Luteal phase insufficiency was suspected in one patient; however, she had hyperprolactinemia during both the follicular and luteal phases. One wonders whether hyperprolactinemia is more detrimental during the follicular phase than during the luteal phase. REFERENCES. Lloyd SJ. Josimovich JB, Archer DF: Amenorrhea and galactorrhea: results of therapy with 2-bromo-aergocryptine (CB-54). Am J Obstet GynecoI22:85, Thorner MO, Besser GM, Jones A, Dacie J, Jones AE: Bromocriptine treatment for female infertility: report of 3 pregnancies. Br Med J 4:694, Franks S, Jacobs HS, Hull MGR, Steel SJ, Nabarro JDN: Management of hyperprolactinaemic amenorrhoea. Br J Obstet Gynaecol 84:24, Griffith RW, Turkalj I, Braun P: Outcome of pregnancy in mothers given bromocriptine. Br J Clin PharmacoI5:227, Seppala M, Hirvonen E, Ranta T: Hyperprolactinaemia and luteal insufficiency. Lancet :229, Coelingh Bennink HJT, van der Steeg HJ: Ovulation induction by bromocryptine (abstr). Fertil Steril 28:347, Smithells RW: Environmental teratogens of man. Br Med Bull 32:27, Herbst AL, Kurman RJ, Scully RE: Vaginal and cervical abnormalities after exposure to stilbestrol in utero. Obstet Gynecol 40:287, Del Pozo E, Wijss H, Lancranjan I, Obolensky W, Varga D: Prolactin-induced luteal insufficiency and its treatment with bromocriptine: preliminary results. In Ovulation in the Human, Edited by PG Crosignani, DR Mishell. London, Academic Press, 975, p L'Hermite M, Caufriez A, Vekemans M, Denayer P, Robyn C: Pharmacological and pathological aspects of human prolactin secretion. Prog Reprod BioI 2:244, 977. Muhlenstedt D, Wuttke W, Schneider HPG: Short luteal phase and prolactin (abstr). Fertil Steril 28:373, McNatty KP, Sawers RS, McNeilly AS: A possible role for prolactin in control of steroid secretion by the human Graafian follicle. Nature 250:653, 974

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