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

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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01973842

Acronym

ATD

Enrollment

Registered

2013-11-01

Start date

2014-02-28

Completion date

2016-07-31

Last updated

2016-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subfertility

Keywords

GnRH agonist, OHSS, Triggering final oocyte maturation

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.

Interventions

DRUG0.1 mg triptorelin

DRUG0.2 mg triptorelin

DRUG0.4 mg triptorelin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Greece

Contacts

Primary ContactEfstratios Kolilbianakis, MD, MSc, PhD

stratis.kolibianakis@gmail.com

Backup ContactGeorgios Lainas, MD

g.lainas@yahoo.co.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026