Evaluation of the Optimal Dose of GnRH Agonist for Triggering Final Oocyte Maturation in High Risk OHSS Patients
ATD
1 other identifier
interventional
90
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2013
CompletedFirst Posted
Study publicly available on registry
November 1, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedFebruary 12, 2016
February 1, 2016
2.4 years
October 25, 2013
February 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of mature oocytes retrieved
Percentage of mature oocytes retrieved following oocyte retrieval
36 hours post GnRH agonst administration
Secondary Outcomes (6)
total number of oocytes retrieved
36 hours post GnRH agonist administration
oocyte recovery rate
36 hours post GnRH agonist administration
Fertilization rate
Day 1 post oocyte retrieval
Serum LH, FSH, E2, PRG levels
8-36 hours post triggering and on days 3-4-7-10 after GnRH agonist administration
Duration of luteal phase
16 days
- +1 more secondary outcomes
Study Arms (3)
0.2 mg triptorelin
ACTIVE COMPARATOR0.2 mg triptorelin compared with 0.1 mg triptorelin and 0.4 mg triptorelin
0.1 mg triptorelin
ACTIVE COMPARATOR0.1 mg triptorelin compared with 0.2 mg triptorelin and 0.4 mg triptorelin
0.4 mg triptorelin
ACTIVE COMPARATOR0.4 mg triptorelin compared with 0.1 mg triptorelin and 0.2 mg triptorelin
Interventions
Eligibility Criteria
You may qualify if:
- Age \< 40 years
- Anticipated high ovarian response
You may not qualify if:
- Endometriosis \> than grade II
- One ovary
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Eugonia IVF Unit
Athens, Greece
Unit of Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
Thessaloniki, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass Professor in Obstetrics - Gynecology and Assisted Reproduction
Study Record Dates
First Submitted
October 25, 2013
First Posted
November 1, 2013
Study Start
February 1, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
February 12, 2016
Record last verified: 2016-02