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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peter Humaidan, Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier:
NCT00627406
First received: February 22, 2008
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
OHSS (Ovarian Hyperstimulation)
Drug: Buserelin and Pregnyl
Drug: Pregnyl
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Regionshospitalet Viborg, Skive:

Primary Outcome Measures:
  • Frequency of Moderate to Severe OHSS. [ Time Frame: From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy Rate [ Time Frame: from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test ] [ Designated as safety issue: No ]

Enrollment: 384
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)
Drug: Buserelin and Pregnyl
Subcutaneous injection 0.5 mg and 1500 IU
Active Comparator: B
More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)
Drug: Pregnyl
Subcutaneous injection 5000 IU
Experimental: 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)
Drug: Buserelin and Pregnyl
Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days
Active Comparator: D
14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)
Drug: Pregnyl
Subcutaneous injection 5000 IU

  Eligibility

Ages Eligible for Study:   20 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627406

Locations
Denmark
The Fertility Clinic, Regional Hospital of Skive
Skive, Denmark, 7800
Sponsors and Collaborators
Regionshospitalet Viborg, Skive
Investigators
Principal Investigator: Peter S Humaidan, MD
  More Information

No publications provided by Regionshospitalet Viborg, Skive

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Humaidan, Prof. M.D. D.M.Sc., Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier: NCT00627406     History of Changes
Other Study ID Numbers: N-VN-2002-0046MCH
Study First Received: February 22, 2008
Results First Received: September 25, 2013
Last Updated: September 25, 2013
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Regionshospitalet Viborg, Skive:
GnRH antagonist
GnRH agonist
hCG
OHSS
In vitro fertilization
ovulation induction
Clinical pregnancy rate

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Buserelin
Chorionic Gonadotropin
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014