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Pulsatile GnRH in Anovulatory Infertility
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.
Details
| Lead sponsor | Massachusetts General Hospital |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 270 |
| Start date | 1989-01 |
| Completion | 2020-09 |
Conditions
- Hypogonadotropic Hypogonadism
- Amenorrhea
- Kallmann's Syndrome
Interventions
- GnRH
- Pump
Primary outcomes
- ovulation — 1 pulsatile GnRH cycle
LH surge or luteal phase progesterone \> 5 ng/dL
Countries
United States