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

March 1, 2017 updated by: khalid mohammed salama, Benha University

Sequential E2 Levels Not Ovarian Maximal Diameter Estimates Were Correlated With Outcome of Cetrotide Therapy for Management of Women at High-risk of Ovarian Hyperstimulation Syndrome

To evaluate safety and efficacy of 3-day cetrotide therapy started on day of oocyte retrieval (Day-0) in women at high-risk for development of ovarian hyperstimulation syndrome (OHSS) after gonadotropin- releasing hormon agonist induction protocol.

Patients & Methods: Forty-eight women fulfilling inclusion criteria underwent ultrasound scanning for maximal ovarian diameter (MOD) estimation and ascites grading. Patients underwent embryo freezing, but study group received 3-day Cetrotide sc injection (0.25 mg/day) started on Day-0. 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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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. The study aimed to include women suspected to be at high risk for development of OHSS during agonist ovarian stimulation protocol.The study includes only women of couples singed written consent to participate in the study, to undergo embryo freezing and to postpone for transfer of cryopreserved embryo.

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. Symptoms are scored using verbal analogue scale as nil, mild, moderate, and severe symptom. Blood samples are obtained under complete aseptic condition for estimation of serum E2 level and determination of hematocrit value (Ht%) and total leucocytic count (TLC).

Then, all patients underwent ultrasound scanning for estimation of ovarian measurements that were represented as the maximal ovarian diameter (MOD) and for ascites grading if present. Ultrasound scanning is performed using a 5 megahertz vaginal probe , otherwise a 3.5 megahertz, 2.6 megahertz or 5megahertz abdominal probe is used if visualization using a vaginal probe is compromised. Ascites is graded according to the quantity of fluid accumulation in the peritoneal cavity with the patient in the anti-Trendelenburg position.

Women fulfilling inclusion criteria were randomely allocated,using sealed envelops, into two equal groups. Group with embryo freezing alone (Control group) or while the other group additionally receives cetrotide subcutaneous injection in a daily dose of 0.25 mg started on day of oocyte retrieval for 3 days (Study group). Symptomatic treatment for associated symptoms as analgesics, antiemetics and antispasmodics are also prescribed. Patients are categorized according to classification grading of OHSS.

Class Clinical features Biochemical features

Mild - Abdominal distension/ discomfort

  • Mild nausea/vomiting
  • Diarrhea
  • Ovarian size usually < 8 cm No clinically important laboratory findings

Moderate - Mild features plus

  • US evidence of ascites - Elevated Ht (>41%)
  • Elevated TLC >15,000/ ml
  • Hypoproteinemia

Severe - Mild & Moderate features plus

  • Clinically detected ascites
  • Severe abdominal pain
  • Intractable nausea
  • Rapid weight gain (>1 kg/24 hr)
  • Pleural effusion
  • Severe dyspnea
  • Oliguria/anuria
  • Low blood/central venous pressures
  • Syncope
  • Venous thrombosis
  • Hemoconcentration (Ht >55%)
  • TLC >25,000/ ml
  • Serum creatinine >1.6 mg/dl
  • creatinine clearance <50 ml/min
  • Hyponatremia (Na+<135milliequivalent per litre)
  • Hypokalemia (K+ < 5 milliequivalent per litre)
  • Elevated liver enzymes

Critical - Severe features plus

  • Anuria/ Acute renal failure
  • Arrhythmia
  • Pericardial effusion
  • Massive hydrothorax
  • Thrombo-embolism
  • Arterial thrombosis
  • (ARDS)Adult respiratory distress syndrome
  • Sepsis - Worsening of biochemical

findings seen with severe OHSS

US: Ultrasound; Ht%:Ht; Hematocrit value; TLC: Total leucocytic count: ARDS; adult respiratory distress syndrome.

All patients are managed as outpatients unless management of severe symptoms necessitated hospital admission. Pain scores, serum E2 levels and MOD are evaluated daily. Patients are evaluated for associated symptoms previously determined during clinical evaluation, ascites grading and TLC and Ht value were evaluated at 3 and 6 days and on end of the trial on the 8th day after oocyte retrieval.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El qalubia
      • Benha, El qalubia, Egypt
        • Benha university hospitalا

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 33 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. number of retrieved oocytes was ≥20
  2. mean number of follicles with a diameter of >16 mm was ≥18
  3. serum E2 concentrations of ≥3500 pg/ml
  4. ovarian diameter on the day of ovum retrieval of >10 cm
  5. presentation of evident symptoms of OHSS on the day of aspiration .

Exclusion Criteria:

1- Absence of one or more of the items of the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: cetrotide
study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. 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.
Drug: Cetrorelix
study group received 3-day Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites control (24 patients) did not receive Cetrorelix Acetate. Grading were re-evaluated on Day-3, 6 and 8.
Other Names:
  • cetrotide
No Intervention: no cetrotide
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Serum E2 Levels
Time Frame: 8 days
Serum E2 levels (Serum E2 level in picograms/ml) were evaluated daily.
8 days
Daily Maximal Ovarian Diameter
Time Frame: 8 days
MOD (maximal ovarian diameter in mm) were evaluated daily.
8 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily Numerical Pain Visual Analogue Scale Score
Time Frame: 8 days.
-All patients were clinically evaluated for the presence of abdominal pain and if present was graduated using a numerical pain visual analogue scale (VAS) with 0 means no pain and 10 means severe intolerable pain .
8 days.
Daily Hematocrits Value
Time Frame: 0-8 days.
Blood samples were obtained under complete aseptic condition for determination of hematocrits value (Ht%)
0-8 days.
Ultrasound Detected Severity Grades of Ascites From Days 0-8
Time Frame: 0-8 days
-US detected severity grades of ascites determined at Day -0, Day -3 and Day -8.
0-8 days
Daily Total Leucocytic Count
Time Frame: 0 -8days.
TLC(x 1ooo cells/ml)
0 -8days.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of Gastrointestinal Manifestations Determined Prior to Start of Therapy
Time Frame: 0-6 days
-severity grades of gastrointestinal manifestations determined at Day -0,Day -3 and Day -6.
0-6 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: khalid M salama, MD, Benha University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 30, 2016

First Posted (Estimate)

July 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 1, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Benha U
  • kmsalama (Registry Identifier: khalid)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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