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

Phase 4

Completed

• Conditions: OHSS (Ovarian Hyperstimulation)
• Interventions: Drug: Buserelin and Pregnyl; Drug: Pregnyl

• Registration Number: NCT00627406
• Lead Sponsor: Regionshospitalet Viborg, Skive

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-22
• Study First Submitted QC: 2008-02-29
• Study First Posted: 2008-03-03
• Study Start: 2009-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-09
• Results First Submitted: 2013-09-25
• Results First Submitted QC: 2013-09-25
• Last Update Submitted: 2013-09-25
• Results First Posted: 2013-11-27
• Last Update Posted: 2013-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 384

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Buserelin and Pregnyl	More than 14 follicles with a diameter of \> 11mm: triggering of ovulation with 0.5 mg GnRHa (Buserelin) (s.c.) + 1500 IU hCG (Pregnyl)
C	Buserelin and Pregnyl	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)
B	Pregnyl	More than 14 follicles with a diameter of \> 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)
D	Pregnyl	14 or less follicles with a diameter of \> 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)

Primary Outcome Measures

Name	Time	Method
Frequency of Moderate to Severe OHSS.	From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test

Secondary Outcome Measures

Name	Time	Method
Pregnancy Rate	from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test

Trial Locations

Locations (1)

The Fertility Clinic, Regional Hospital of Skive; 🇩🇰 Skive, Denmark