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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00383656
Other study ID # 1999-P-004396
Secondary ID 5U54HD028138
Status Recruiting
Phase Phase 2
First received September 29, 2006
Last updated July 9, 2017
Start date January 1989
Est. completion date September 2020

Study information

Verified date July 2017
Source Massachusetts General Hospital
Contact Janet E Hall, M.D.
Phone 617-726-1117
Email jehall@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Drug:
GnRH
75 ng/kg GnRH IV
Device:
Pump
portable, infusion pump for GnRH

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (14)

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Outcome

Type Measure Description Time frame Safety issue
Other LH LH levels from days 1-7of treatment of treatment 1st 7 days of treatment
Other FSH FSH levels from days 1-7 of treatment 1st 7 days of treatment
Primary ovulation LH surge or luteal phase progesterone > 5 ng/dL 1 pulsatile GnRH cycle
Secondary pregnancy serum HCG indicative of pregnancy 6 weeks
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