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

Primary Purpose

Subfertility

Status
Unknown status
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
0.1 mg triptorelin
0.2 mg triptorelin
0.4 mg triptorelin
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subfertility focused on measuring GnRH agonist, OHSS, Triggering final oocyte maturation

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Eugonia IVF UnitRecruiting
  • Unit of Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of ThessalonikiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

0.2 mg triptorelin

0.1 mg triptorelin

0.4 mg triptorelin

Arm Description

0.2 mg triptorelin compared with 0.1 mg triptorelin and 0.4 mg triptorelin

0.1 mg triptorelin compared with 0.2 mg triptorelin and 0.4 mg triptorelin

0.4 mg triptorelin compared with 0.1 mg triptorelin and 0.2 mg triptorelin

Outcomes

Primary Outcome Measures

Percentage of mature oocytes retrieved
Percentage of mature oocytes retrieved following oocyte retrieval

Secondary Outcome Measures

total number of oocytes retrieved
oocyte recovery rate
Fertilization rate
Serum LH, FSH, E2, PRG levels
Duration of luteal phase
OHSS occurrence
Occurrence of ovarian hyperstimulation syndrome

Full Information

First Posted
October 25, 2013
Last Updated
February 11, 2016
Sponsor
Aristotle University Of Thessaloniki
Collaborators
Eugonia IVF Unit, Athens, Greece
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1. Study Identification

Unique Protocol Identification Number
NCT01973842
Brief Title
Evaluation of the Optimal Dose of GnRH Agonist for Triggering Final Oocyte Maturation in High Risk OHSS Patients
Acronym
ATD
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
Collaborators
Eugonia IVF Unit, Athens, Greece

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfertility
Keywords
GnRH agonist, OHSS, Triggering final oocyte maturation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0.2 mg triptorelin
Arm Type
Active Comparator
Arm Description
0.2 mg triptorelin compared with 0.1 mg triptorelin and 0.4 mg triptorelin
Arm Title
0.1 mg triptorelin
Arm Type
Active Comparator
Arm Description
0.1 mg triptorelin compared with 0.2 mg triptorelin and 0.4 mg triptorelin
Arm Title
0.4 mg triptorelin
Arm Type
Active Comparator
Arm Description
0.4 mg triptorelin compared with 0.1 mg triptorelin and 0.2 mg triptorelin
Intervention Type
Drug
Intervention Name(s)
0.1 mg triptorelin
Intervention Type
Drug
Intervention Name(s)
0.2 mg triptorelin
Intervention Type
Drug
Intervention Name(s)
0.4 mg triptorelin
Primary Outcome Measure Information:
Title
Percentage of mature oocytes retrieved
Description
Percentage of mature oocytes retrieved following oocyte retrieval
Time Frame
36 hours post GnRH agonst administration
Secondary Outcome Measure Information:
Title
total number of oocytes retrieved
Time Frame
36 hours post GnRH agonist administration
Title
oocyte recovery rate
Time Frame
36 hours post GnRH agonist administration
Title
Fertilization rate
Time Frame
Day 1 post oocyte retrieval
Title
Serum LH, FSH, E2, PRG levels
Time Frame
8-36 hours post triggering and on days 3-4-7-10 after GnRH agonist administration
Title
Duration of luteal phase
Time Frame
16 days
Title
OHSS occurrence
Description
Occurrence of ovarian hyperstimulation syndrome
Time Frame
16 days post triggering

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Efstratios Kolilbianakis, MD, MSc, PhD
Email
stratis.kolibianakis@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Georgios Lainas, MD
Email
g.lainas@yahoo.co.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Efstratios Kolibianakis, MD, MSc, PhD
Organizational Affiliation
Unit of Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki Thessaloniki, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eugonia IVF Unit
City
Athens
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trifon Lainas, MD, PhD
Email
tlainas@otenet.gr
First Name & Middle Initial & Last Name & Degree
Trifon Lainas, MD, PhD
Facility Name
Unit of Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
City
Thessaloniki
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Efstratios Kolibianakis, MD, MSc, PhD
Email
stratis.kolibianakis@gmail.com
First Name & Middle Initial & Last Name & Degree
Efstratios Kolibianakis, MD, MSc, PhD
First Name & Middle Initial & Last Name & Degree
Georgios Lainas, MD

12. IPD Sharing Statement

Learn more about this trial

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

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