Baselines in Reproductive Disorders

Status unconfirmed · Not applicable

Conditions studied: Amenorrhea, Hypogonadotropic Hypogonadism, Kallmann's Syndrome

In brief

The purpose of the study is to explore the way in which gonadotropins (pituitary hormones) are released into the body. The knowledge acquired in this study will be used for the diagnosis and treatment of reproductive endocrine disorders. We seek to investigate the baseline characteristics of the GnRH-induced gonadotropin pulsations of patients with the following diagnoses: * Hypothalamic Amenorrhea (HA) * Idiopathic hypogonadotropic hypogonadism (IHH) * Polycystic ovarian disease (PCOD) * Acquired hypogonadotropic hypogonadism (AHH) * Premature Ovarian Failure (POF) \*\*WE ARE CURRENTLY RECRUITING ONLY SUBJECTS WITH A DIAGNOSIS OF IHH.\*\* This has been an extremely productive and pivotal protocol in the studies of female reproductive physiology and pathophysiology and continues to be critical for defining the neuroendocrine abnormalities in patients with reproductive disorders. In some cases, it is also helpful in the planning of subsequent therapy if so desired. It is important to note that minors have been included in this protocol, as many patients are extremely anxious to know more about their neuroendocrine disorder. With minors who would like to know if their disorder is correctable, this protocol may be followed up with administration of pulsatile gonadotropin-releasing hormone (GnRH).

Key facts

Study ID

NCT00456274

Run by

Massachusetts General Hospital

People needed

180

Starts

1999-09-01

Expected to finish

2020-09-01

Last updated by the study team

2014-08-04

Who can join

Age: 16 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Healthy women between the ages of 16-45 years
• Negative pregnancy test
• On no gonadal steroid preparations for at least 3 months, with the exception of the idiopathic hypogonadotropic hypogonadism (IHH) group, they should be off gonadal steroid for at least 4 weeks
• The following test will be performed if they had not been done in the last 2 months
• Normal blood count
• Normal thyroid function test

You may not qualify if…

• Hemoglobin levels less than 11 gm/dL
• Positive pregnancy test
• Abnormal thyroid function
• Abnormal MRI (IHH)

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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