Triggering of Final Oocyte Maturation With GnRHa (Buserelin) in GnRH Antagonist Cycles

Regionshospitalet Viborg, Skive

Status and phase: Completed; Phase 4

Conditions: OHSS (Ovarian Hyperstimulation)

Treatments: Drug: Pregnyl; Drug: Buserelin and Pregnyl

Study type: Interventional

Funder types: Other

Identifiers

NCT00627406

N-VN-2002-0046MCH

Details and patient eligibility

About

The purpose of this study is to possibly further improve the clinical outcome and explore the incidence of OHSS in patients, who have final oocyte maturation with GnRHa (Buserelin) in GnRH antagonist IVF/ICSI cycles

Enrollment: 384 patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient complying with the conditions for IVF or ICSI treatment
• Female age over 20 years and under 40 years
• Normal regular cycle and patients with oligomenorrhea
• BMI > 18 and < 35
• each patient contributes with one cycle only

Exclusion criteria

• Significant disturbances in the woman (diabetes, epilepsy, liver/renal/heart disease, metabolic disorder)
• Patients with > 25 follicles on the day of triggering ovulation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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384 participants in 4 patient groups

A

Experimental group

Description:

More than 14 follicles with a diameter of \> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)

Treatment:

Drug: Buserelin and Pregnyl

Drug: Buserelin and Pregnyl

B

Active Comparator group

Description:

More than 14 follicles with a diameter of \> 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)

Treatment:

Drug: Pregnyl

Drug: Pregnyl

C

Experimental group

Description:

14 or less follicles with a diameter of \> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl) (s.c.) at 35 hours and 1500 IU hCG (Pregnyl) (s.c.) 7 days after triggering of ovulation (OPU + 5)

Treatment:

Drug: Buserelin and Pregnyl

Drug: Buserelin and Pregnyl

D

Active Comparator group

Description:

14 or less follicles with a diameter of \> 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)

Treatment:

Drug: Pregnyl

Drug: Pregnyl