Evaluation of the Optimal Dose of GnRH Agonist for Triggering Final Oocyte Maturation in High Risk OHSS Patients (ATD)

February 11, 2016 updated by: E.M. Kolibianakis, Aristotle University Of Thessaloniki

Evaluation of the Optimal Dose of GnRH Agonist for Triggering Final Oocyte Maturation in High Risk OHSS Patients Undergoing Ovarian Stimulation for IVF With GnRH Antagonists and Recombinant FSH.

The present study aims to investigate whether the dosage of the GnRH agonist used for triggering final oocyte maturation affects the maturity of the oocytes retrieved in high risk for OHSS patients undergoing ovarian stimulation for IVF using GnRH antagonists and recombinant FSH.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Three different doses of GnRH agonist (0.1mg, 0.2mg or 0.4 mg) will be used randomly to trigger final oocyte maturation. The primary outcome measure will be the percentage of mature oocytes retrieved.

Secondary outcomes will include: number of oocytes retrieved, oocyte recovery rate (number of oocytes retrieved/ number of follicles >11mm in diameter on the day of triggering), fertilization rates and OHSS occurrence.

Serum LH, FSH, E2, PRG levels will be assessed at 8-36 hours following agonist administration and on days 3-4-7-10 after triggering final oocyte maturation.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

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

  • Greece
      • Athens, Greece
        • Recruiting
        • Eugonia IVF Unit
        • Contact:
        • Principal Investigator:
          • Trifon Lainas, MD, PhD
      • Thessaloniki, Greece
        • Recruiting
        • Unit of Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
        • Contact:
        • Principal Investigator:
          • Efstratios Kolibianakis, MD, MSc, PhD
        • Sub-Investigator:
          • Georgios Lainas, MD

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

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria: Patients undergoing ovarian stimulation for IVF using GnRH antagonist protocol

  • Age < 40 years
  • Anticipated high ovarian response

Exclusion Criteria:

  • Endometriosis > than grade II
  • One ovary

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 0.2 mg triptorelin
0.2 mg triptorelin compared with 0.1 mg triptorelin and 0.4 mg triptorelin
Drug: 0.2 mg triptorelin
ACTIVE_COMPARATOR: 0.1 mg triptorelin
0.1 mg triptorelin compared with 0.2 mg triptorelin and 0.4 mg triptorelin
Drug: 0.1 mg triptorelin
ACTIVE_COMPARATOR: 0.4 mg triptorelin
0.4 mg triptorelin compared with 0.1 mg triptorelin and 0.2 mg triptorelin
Drug: 0.4 mg triptorelin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of mature oocytes retrieved
Time Frame: 36 hours post GnRH agonst administration
Percentage of mature oocytes retrieved following oocyte retrieval
36 hours post GnRH agonst administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OHSS occurrence
Time Frame: 16 days post triggering
Occurrence of ovarian hyperstimulation syndrome
16 days post triggering
total number of oocytes retrieved
Time Frame: 36 hours post GnRH agonist administration
36 hours post GnRH agonist administration
oocyte recovery rate
Time Frame: 36 hours post GnRH agonist administration
36 hours post GnRH agonist administration
Fertilization rate
Time Frame: Day 1 post oocyte retrieval
Day 1 post oocyte retrieval
Serum LH, FSH, E2, PRG levels
Time Frame: 8-36 hours post triggering and on days 3-4-7-10 after GnRH agonist administration
8-36 hours post triggering and on days 3-4-7-10 after GnRH agonist administration
Duration of luteal phase
Time Frame: 16 days
16 days

Collaborators and Investigators

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

Sponsor

Aristotle University Of Thessaloniki

Collaborators

Eugonia IVF Unit, Athens, Greece

Investigators

  • Principal Investigator: Efstratios Kolibianakis, MD, MSc, PhD, Unit of Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki Thessaloniki, Greece

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

February 1, 2014

Primary Completion (ANTICIPATED)

July 1, 2016

Study Completion (ANTICIPATED)

July 1, 2016

Study Registration Dates

First Submitted

October 25, 2013

First Submitted That Met QC Criteria

October 27, 2013

First Posted (ESTIMATE)

November 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2016

Last Update Submitted That Met QC Criteria

February 11, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Agonist triggering dose

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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