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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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OHSS (Ovarian Hyperstimulation)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

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

Group Type EXPERIMENTAL

Buserelin and Pregnyl

Intervention Type DRUG

Subcutaneous injection 0.5 mg and 1500 IU

B

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

Group Type ACTIVE_COMPARATOR

Pregnyl

Intervention Type DRUG

Subcutaneous injection 5000 IU

C

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)

Group Type EXPERIMENTAL

Buserelin and Pregnyl

Intervention Type DRUG

Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days

D

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

Group Type ACTIVE_COMPARATOR

Pregnyl

Intervention Type DRUG

Subcutaneous injection 5000 IU

Interventions

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Buserelin and Pregnyl

Subcutaneous injection 0.5 mg and 1500 IU

Intervention Type DRUG

Pregnyl

Subcutaneous injection 5000 IU

Intervention Type DRUG

Buserelin and Pregnyl

Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days

Intervention Type DRUG

Pregnyl

Subcutaneous injection 5000 IU

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No