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

Aristotle University Of Thessaloniki

Status and phase: Unknown; Phase 2

Conditions: Subfertility

Treatments: Drug: 0.1 mg triptorelin; Drug: 0.2 mg triptorelin; Drug: 0.4 mg triptorelin

Study type: Interventional

Funder types: Other

Identifiers

NCT01973842

Agonist triggering dose

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups

0.2 mg triptorelin

Active Comparator group

Description:

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

Treatment:

Drug: 0.2 mg triptorelin

0.1 mg triptorelin

Active Comparator group

Description:

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

Treatment:

Drug: 0.1 mg triptorelin

0.4 mg triptorelin

Active Comparator group

Description:

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

Treatment:

Drug: 0.4 mg triptorelin