Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01973842
Recruitment Status : Unknown
Verified February 2016 by E.M. Kolibianakis, Aristotle University Of Thessaloniki.
Recruitment status was:  Recruiting
First Posted : November 1, 2013
Last Update Posted : February 12, 2016
Sponsor:
Collaborator:
Eugonia IVF Unit, Athens, Greece
Information provided by (Responsible Party):
E.M. Kolibianakis, Aristotle University Of Thessaloniki

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.

Condition or disease Intervention/treatment Phase
Subfertility Drug: 0.1 mg triptorelin Drug: 0.2 mg triptorelin Drug: 0.4 mg triptorelin Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2014
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Percentage of mature oocytes retrieved [ Time Frame: 36 hours post GnRH agonst administration ]
    Percentage of mature oocytes retrieved following oocyte retrieval


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973842


Contacts
Layout table for location contacts
Contact: Efstratios Kolilbianakis, MD, MSc, PhD stratis.kolibianakis@gmail.com
Contact: Georgios Lainas, MD g.lainas@yahoo.co.uk

Locations
Layout table for location information
Greece
Eugonia IVF Unit Recruiting
Athens, Greece
Contact: Trifon Lainas, MD, PhD       tlainas@otenet.gr   
Principal Investigator: Trifon Lainas, MD, PhD         
Unit of Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki Recruiting
Thessaloniki, Greece
Contact: Efstratios Kolibianakis, MD, MSc, PhD       stratis.kolibianakis@gmail.com   
Principal Investigator: Efstratios Kolibianakis, MD, MSc, PhD         
Sub-Investigator: Georgios Lainas, MD         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Eugonia IVF Unit, Athens, Greece
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: E.M. Kolibianakis, Ass Professor in Obstetrics - Gynecology and Assisted Reproduction, Aristotle University Of Thessaloniki
ClinicalTrials.gov Identifier: NCT01973842     History of Changes
Other Study ID Numbers: Agonist triggering dose
First Posted: November 1, 2013    Key Record Dates
Last Update Posted: February 12, 2016
Last Verified: February 2016

Keywords provided by E.M. Kolibianakis, Aristotle University Of Thessaloniki:
GnRH agonist
OHSS
Triggering final oocyte maturation

Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Genital Diseases, Male
Genital Diseases, Female
Deslorelin
Triptorelin Pamoate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents