GnRH Antagonist for Treatment of Early Ovarian Hyperstimulation Syndrome

Usefulness of GnRH Antagonist Administration in the Treatment of Early Ovarian Hyperstimulation Syndrome

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01268761

Enrollment

100

Registered

2010-12-31

Start date

2012-04-30

Completion date

2013-07-31

Last updated

2013-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Hyperstimulation Syndrome, Effects of Gonadotropin, Oocyte Maturation

Keywords

Ovarian hyperstimulation syndrome (OHSS), GnRH antagonist, Ascitis.

Brief summary

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

Detailed 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).

Interventions

DRUGGnRH antagonist (Cetrorelix)

•GnRH antagonist (Cetrorelix 0.25) during 7 days beginning administration the second day of oocyte retrieval

DRUGPlacebo (saline solution)

• Placebo (saline solution) 1 ampoule every 24 hours during 7 days beginning administration the second day of oocyte retrieval

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Ultrasound	one week	Ultrasound measurements: ascitis and ovarian size
Blood measurements	one week	Blood measurements: hyperstimulation biomarkers, liver and kidney function and hormonal profile.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026