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

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ClinicalTrials.gov Identifier: NCT00627406
Recruitment Status : Completed
First Posted : March 3, 2008
Results First Posted : November 27, 2013
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
Peter Humaidan, 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

Condition or disease Intervention/treatment Phase
OHSS (Ovarian Hyperstimulation) Drug: Buserelin and Pregnyl Drug: Pregnyl Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : January 2009
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pregnancy Rate [ Time Frame: from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test ]


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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 3, 2008    Key Record Dates
Results First Posted: November 27, 2013
Last Update Posted: November 27, 2013
Last Verified: September 2013

Keywords provided by Peter Humaidan, 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
Chorionic Gonadotropin
Buserelin
Reproductive Control Agents
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents