Trial | NCT01581944  Report issue

Title

Gonadotropin-releasing Hormone Agonist Prior to Myomectomy
Phase 3 Study of Experience With a Gonadotropin-releasing Hormone Agonist Prior to Myomectomy - Comparison of 2 Versus 3 Monthly Doses.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    goserelin ...

  • Study Participants

    68
Fibroids are common in the West Indian population (30-40% of reproductive women).Fibroids are benign growth in the womb or uterus and in order to preserve the fertility of women they, require an operation called myomectomy or shelling out of the fibroid. This procedure can be associated with large blood loss.

In current practice some obstetricians use a gonadotropin releasing hormone agonist prior to the operation to reduce blood loss. Gonadotropin releasing hormone agonist is used in current gynaecological practice to treat women with heavy periods.

In this study the investigators randomised women to either 2 or 3 doses of the gonadotropin agonist prior to their operation and no treatment. The intraoperative blood loss was measured. The study hypothesis: To determine whether administration of gonadotropin releasing hormone agonist prior to myomectomy reduces intraoperative blood loss.
Variables noted preoperatively:

Age
Parity
Ethnicity
Ultrasound findings

Variables noted intra-operatively:

Size of largest fibroid
Estimated blood loss
Study Started
Jan 31
2008
Primary Completion
Dec 31
2011
Study Completion
Dec 31
2011
Last Update
Apr 20
2012
Estimate

Drug 2 Doses Goserelin

3.6mg administered monthly for 2 months prior to myomectomy

  • Other names: Gonadotropin Releasing Hormone Agonist

Drug 3 Doses Goserelin

3.6mg administered monthly for 3 months prior to myomectomy

  • Other names: Gonadotropin Releasing Hormone Agonist

No Treatment (Control) No Intervention

Women were randomised to receive no gonadotropin-releasing hormone agonist prior to myomectomy.

2 Doses Goserelin Experimental

Women were randomised to receive 2 doses of 3.6mg of gonadotropin releasing hormone agonist prior to the myomectomy.

3 Doses Goserelin Experimental

Women were randomised to receive 3 doses of the gonadotropin-releasing agonist (3.6mg monthly injections).

Criteria 

Inclusion Criteria:

Women between the age of 20 and 45
Symptomatic fibroids
Presence of regular menstrual cycles
Ultrasound confirmation of fibroids
Normal cervical smear

Exclusion Criteria:

Pregnancy
The length of hospital stay was calculated in number of days from the date of the to the date of discharge
Presence of endometriosis Previous myomectomy Ovarian, uterine or cervical malignancy female factor for subfertility
No Results Posted