Pulsatile GnRH in Anovulatory Infertility
Hypogonadotropic Hypogonadism, Amenorrhea, Kallmann's Syndrome
About this trial
This is an interventional treatment trial for Hypogonadotropic Hypogonadism focused on measuring gonadotropin releasing hormone, GnRH deficiency, hypothalamic amenorrhea, hypogonadotropic hypogonadism, Kallman's syndrome, infertility
Eligibility Criteria
Inclusion Criteria:
- Women and minors with GnRH deficiency or idiopathic hypogonadotropic hypogonadism (IHH) will have a history of primary amenorrhea, no evidence of abnormalities in other hormonal axes, a deficient pattern of luteinizing hormone (LH) and/or free alpha subunit (FAS) secretion on baseline sampling and a normal cranial CT or MRI.
- Women and minors with hypothalamic amenorrhea will have a history of secondary amenorrhea of at least six months duration with low or normal gonadotropins or a history of primary amenorrhea in the presence of pulsatile patterns of LH or FAS on baseline frequent sampling studies, BMI > 18 kg/m2 and normal testosterone and prolactin levels.
- Women and minors with acquired hypogonadotropic hypogonadism will have a history of hypothalamic or pituitary tumor treated with surgery alone or in combination with radiotherapy or a history of hypothalamic irradiation as adjunctive therapy for leukemia or craniofacial neoplasms. There must be a minimum of 2 years since irradiation and no gonadal radiation. For the previous two months, patients will be euthyroid on thyroid replacement if needed, normoprolactinemic on dopamine agonists if needed, and receiving physiologic glucocorticoid replacement if needed.
Subjects will be otherwise healthy women and female minors between the ages of 16 and 45 years who have not been on gonadal steroid preparations for at least 1 month. Subjects will have normal complete blood count (hemoglobin greater than or equal to 11.5gm/dl) and thyroid function tests and a negative pregnancy test.
Exclusion Criteria:
Mitral valve prolapse with ballooning of the mitral valve will be cause for exclusion of the patient from intravenous GnRH treatment.
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Pulsatile GnRH
All participants will be administered GnRH intravenously by means of a portable infusion pump that delivers boluses at specific intervals.