Outcome of Cetrotide Therapy for Management of Women at High-risk of Ovarian Hyperstimulation Syndrome

What Was Tested

The trial (phase 2, phase 3) is built around Cetrorelix.

Patients \& Methods: Forty-eight women fulfilling inclusion criteria underwent ultrasound scanning for maximal ovarian diameter (MOD) estimation and ascites grading.

It had two arms (groups): cetrotide (active comparator) and no cetrotide (no intervention).

Control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.

The registry classes the interventions as drug.

More on the Plan

The current study is conducted at Assisted Reproduction Unit at Almana general Hospital, kingdom of saudi arabia.and other private centers in Egypt.

The study protocol was approved by the Local Ethical Committee.

All patients are clinically evaluated for the presence of abdominal pain and if present will be graduated using a numerical pain visual analogue scale (VAS) with 0 means no pain and 10 means severe intolerable pain.

Patients are evaluated for the presence of nausea and/or vomiting and sense of abdominal distension.

Who Took Part

The registry lists 48 actual participants took part.

It was open to women only aged from 20 years up to 35 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Number of retrieved oocytes was ≥20. Mean number of follicles with a diameter of \>16 mm was ≥18. Serum E2 concentrations of ≥3500 pg/ml. Ovarian diameter on the day of ovum retrieval of \>10 cm. Presentation of evident symptoms of OHSS on the day of aspiration .

The full record lists 5 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Cetrorelix study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cetrorelix group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Cetrorelix.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2014-10 with completion listed for 2017-04.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Daily Serum E2 Levels (time frame: 8 days). Daily Maximal Ovarian Diameter (time frame: 8 days).

It also tracked 4 secondary outcomes, for example Daily Numerical Pain Visual Analogue Scale Score, Daily Hematocrits Value, Ultrasound Detected Severity Grades of Ascites From Days 0-8 and Daily Total Leucocytic Count.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Cetrorelix in 48 people.

Its status is unknown; results are posted on the registry, and this page does not restate them.

More context: the Cetrorelix compound page, all human trials.