Recruiting
Phase 2

Pulsatile GnRH

Sponsor:

Massachusetts General Hospital

Code:

NCT00383656

Conditions

Hypogonadotropic Hypogonadism

Amenorrhea

Kallmann's Syndrome

Eligibility Criteria

Sex: Female

Age: 16 - 45

Healthy Volunteers: Not accepted

Interventions

GnRH

Pump

Study Details

Brief summary:

The purpose of this study is to explore the effects of synthetic gonadotropin-releasing hormone (GnRH) upon the pituitary and ovaries of women with infertility. Women diagnosed with GnRH deficiency, hypothalamic amenorrhea or acquired hypogonadic hypogonadism, will participate in this study. It is hoped that administration of GnRH will lead to proper stimulation of the pituitary gland and to normal ovulation and menstruation.

\*\*WE ARE CURRENTLY RECRUITING ONLY WOMEN WITH A DIAGNOSIS OF IDIOPATHIC HYPOGONADIC HYPOGONADISM (IHH)\*\*

Pulsatile GnRH has been approved by the FDA for use in women with primary amenorrhea due to complete GnRH deficiency. The overall goals of this protocol are to continue to use pulsatile GnRH in GnRH-deficient and other anovulatory women for ovulation induction and to examine specific physiologic hypotheses, which can only be addressed in this patient population.

Conditions

Hypogonadotropic Hypogonadism

Amenorrhea

Kallmann's Syndrome

Study ID

NCT00383656

Start date

Jan, 1989

Status verified date

Jul, 2017

Completion date

Sep, 2020

Anticipated

Primary completion date

Sep, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 16 - 45

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

270 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pulsatile GnRH

All participants will be administered GnRH intravenously by means of a portable infusion pump that delivers boluses at specific intervals.

Interventions

GnRH

75 ng/kg GnRH IV

Pump

portable, infusion pump for GnRH

Primary outcome measure

  • ovulation [ Time Frame: 1 pulsatile GnRH cycle ]

Central Contacts and Locations

Central contacts

Janet E Hall, M.D.

617-726-1117jehall@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Jul 12, 2017

Last verified

Jul, 2017

Keywords

  • gonadotropin releasing hormone
  • GnRH deficiency
  • hypothalamic amenorrhea
  • hypogonadotropic hypogonadism
  • Kallman's syndrome
  • infertility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2017-07-12.