GnRH Antagonist for Treatment of Early Ovarian Hyperstimulation Syndrome

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status and phase: Completed; Phase 3

Conditions: Ovarian Hyperstimulation Syndrome; Oocyte Maturation; Effects of Gonadotropin

Treatments: Drug: Placebo (saline solution); Drug: GnRH antagonist (Cetrorelix)

Study type: Interventional

Funder types: Other

Identifiers

NCT01268761

0810-C-052-JG

Details and patient eligibility

About

The aim of this study is to analyze the effectiveness of GnRh antagonist in the treatment of early ovarian hyperstimulation syndrome.

Full description

Ovarian hyperstimulation syndrome (OHSS) is a serious complication of ovarian stimulation protocols. Gonadotrophin-releasing hormone (GnRH) antagonist administration in the luteal phase was recently proposed as a new approach for the management of patients with established severe OHSS We analyze the response of egg donors with moderate- severe early ovarian hyperstimulation syndrome after a GnRH antagonist stimulation protocol to the administration of a daily doses of GnRH antagonist (Cetrorelix 0.25) during 7 days after the second day of oocyte retrieval compared with placebo (saline solution).

Enrollment: 100 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Egg donors
• Volunteers.
• 18-35 years old
• Healthy
• BMI < 30
• OHHS after oocyte retrieval defined as ascitis > 9 cm2 associate to abdominal pain, sickness, abdominal distention,or haematocrit (Ht) >45% an white blood cell count >15,000/mm3 or creatine > 1.2 mg/dl or transaminases > 40 IU/liter

Exclusion criteria

• BMI > 30
• Allergy to GnRH antagonist

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

GnRH antagonist

Experimental group

Description:

• GnRH antagonist (Cetrorelix 0.25)

Treatment:

Drug: GnRH antagonist (Cetrorelix)

Placebo (saline solution)

Placebo Comparator group

Description:

• Placebo (saline solution)

Treatment:

Drug: Placebo (saline solution)