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

OHSS (Ovarian Hyperstimulation) Clinical Trial

Official title:

A Prospective Randomised Study to Evaluate the Effect of Triggering Ovulation With GnRHa (Buserelin) and Low Dose hCG (Pregnyl) as Compared to the Use of Conventional Doses of hCG (Pregnyl)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627406
• Other study ID #: N-VN-2002-0046MCH
• Status: Completed
• Phase: Phase 4
• First received: February 22, 2008
• Last updated: September 25, 2013
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: September 2013
• Source: Regionshospitalet Viborg, Skive
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• OHSS (Ovarian Hyperstimulation)
• Ovarian Hyperstimulation Syndrome

Intervention

Drug:
• Buserelin and Pregnyl
Subcutaneous injection 0.5 mg and 1500 IU
• Pregnyl
Subcutaneous injection 5000 IU
• Buserelin and Pregnyl
Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days
• Pregnyl
Subcutaneous injection 5000 IU

Locations

Country	Name	City	State
Denmark	The Fertility Clinic, Regional Hospital of Skive	Skive

Sponsors (1)

Lead Sponsor	Collaborator
Regionshospitalet Viborg, Skive

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pregnancy Rate		from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test	No