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

Subfertility Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01973842
• Other study ID #: Agonist triggering dose
• Status: Recruiting
• Phase: Phase 2
• First received: October 25, 2013
• Last updated: February 11, 2016
• Start date: February 2014
• Est. completion date: July 2016

Study information

• Verified date: February 2016
• Source: Aristotle University Of Thessaloniki
• Contact: Efstratios Kolilbianakis, MD, MSc, PhD
• Email: stratis.kolibianakis[@]gmail.com
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Subfertility

Intervention

Drug:
• 0.1 mg triptorelin

• 0.2 mg triptorelin

• 0.4 mg triptorelin

Locations

Country	Name	City	State
Greece	Eugonia IVF Unit	Athens
Greece	Unit of Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	Eugonia IVF Unit, Athens, Greece

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of mature oocytes retrieved	Percentage of mature oocytes retrieved following oocyte retrieval	36 hours post GnRH agonst administration	No
Secondary	total number of oocytes retrieved		36 hours post GnRH agonist administration	No
Secondary	oocyte recovery rate		36 hours post GnRH agonist administration	No
Secondary	Fertilization rate		Day 1 post oocyte retrieval	No
Secondary	Serum LH, FSH, E2, PRG levels		8-36 hours post triggering and on days 3-4-7-10 after GnRH agonist administration	No
Secondary	Duration of luteal phase		16 days	No
Secondary	OHSS occurrence	Occurrence of ovarian hyperstimulation syndrome	16 days post triggering	Yes