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

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)

Sponsors

Lead Sponsor: Regionshospitalet Viborg, Skive

Source 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

Overall Status Completed
Start Date 2009-01-01
Completion Date 2011-12-01
Primary Completion Date 2011-12-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Measure Time Frame
Pregnancy Rate from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test
Enrollment 384
Condition
Intervention

Intervention Type: Drug

Intervention Name: Buserelin and Pregnyl

Description: Subcutaneous injection 0.5 mg and 1500 IU

Arm Group Label: A

Intervention Type: Drug

Intervention Name: Pregnyl

Description: Subcutaneous injection 5000 IU

Arm Group Label: B

Intervention Type: Drug

Intervention Name: Buserelin and Pregnyl

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

Arm Group Label: C

Intervention Type: Drug

Intervention Name: Pregnyl

Description: Subcutaneous injection 5000 IU

Arm Group Label: D

Eligibility

Criteria:

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

Gender:

Female

Minimum Age:

20 Years

Maximum Age:

39 Years

Healthy Volunteers:

No

Overall Official
Last Name Role
Peter S Humaidan, MD Principal Investigator
Location
Facility: The Fertility Clinic, Regional Hospital of Skive
Location Countries

Denmark

Verification Date

2013-09-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Regionshospitalet Viborg, Skive

Investigator Full Name: Peter Humaidan

Investigator Title: Prof. M.D. D.M.Sc.

Keywords
Has Expanded Access No
Number Of Arms 4
Arm Group

Label: A

Type: Experimental

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)

Label: B

Type: Active Comparator

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

Label: C

Type: Experimental

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)

Label: D

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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