Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 77 of 415 for:    Gonadotrophin, Chorionic AND Choriogonadotropin Alfa

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition OHSS (Ovarian Hyperstimulation)
Interventions Drug: Buserelin and Pregnyl
Drug: Pregnyl
Enrollment 384
Recruitment Details Recruitment period from jan. 2009 to dec. 2011. Participanting Clinics Fertility clinic Regional Hospital Skive, University Hostipal Odense, Regional Hospital Holbaek, Denmark.
Pre-assignment Details  
Arm/Group Title A: >14 Follicles; GnRHa Trigger + 1500 hCG B: >14 Follicles; hCG Trigger C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 D: <15 Follicles; hCG Trigger
Hide Arm/Group 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)

Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU

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

Pregnyl : Subcutaneous injection 5000 IU

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)

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

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

Pregnyl : Subcutaneous injection 5000 IU

Period Title: Overall Study
Started 60 58 125 141
Completed 60 58 125 141
Not Completed 0 0 0 0
Arm/Group Title A: >14 Follicles; GnRHa Trigger + 1500 hCG B: >14 Follicles; hCG Trigger C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 D: <15 Follicles; hCG Trigger Total
Hide Arm/Group 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)

Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU

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

Pregnyl : Subcutaneous injection 5000 IU

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)

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

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

Pregnyl : Subcutaneous injection 5000 IU

Total of all reporting groups
Overall Number of Baseline Participants 60 58 125 141 384
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 58 participants 125 participants 141 participants 384 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
60
 100.0%
58
 100.0%
125
 100.0%
141
 100.0%
384
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 58 participants 125 participants 141 participants 384 participants
28.5  (5.2) 29.8  (3.8) 30.8  (3.9) 31.5  (3.7) 30.2  (4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 58 participants 125 participants 141 participants 384 participants
Female
60
 100.0%
58
 100.0%
125
 100.0%
141
 100.0%
384
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Denmark Number Analyzed 60 participants 58 participants 125 participants 141 participants 384 participants
60 58 125 141 384
1.Primary Outcome
Title Frequency of Moderate to Severe OHSS.
Hide Description [Not Specified]
Time Frame From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test
Hide Outcome Measure Data
Hide Analysis Population Description
No power calculation was proformed.
Arm/Group Title A: >14 Follicles; GnRHa Trigger + 1500 hCG B: >14 Follicles; hCG Trigger C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 D: <15 Follicles; hCG Trigger
Hide Arm/Group 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)

Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU

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

Pregnyl : Subcutaneous injection 5000 IU

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)

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

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

Pregnyl : Subcutaneous injection 5000 IU

Overall Number of Participants Analyzed 60 58 125 141
Measure Type: Number
Unit of Measure: participants
0 2 2 0
2.Secondary Outcome
Title Pregnancy Rate
Hide Description [Not Specified]
Time Frame from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A: >14 Follicles; GnRHa Trigger + 1500 hCG B: >14 Follicles; hCG Trigger C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 D: <15 Follicles; hCG Trigger
Hide Arm/Group 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)

Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU

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

Pregnyl : Subcutaneous injection 5000 IU

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)

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

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

Pregnyl : Subcutaneous injection 5000 IU

Overall Number of Participants Analyzed 60 58 125 141
Measure Type: Number
Unit of Measure: participants
17 15 37 36
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A: >14 Follicles; GnRHa Trigger + 1500 hCG B: >14 Follicles; hCG Trigger C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 D: <15 Follicles; hCG Trigger
Hide Arm/Group 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)

Buserelin and Pregnyl : Subcutaneous injection 0.5 mg and 1500 IU

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

Pregnyl : Subcutaneous injection 5000 IU

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)

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

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

Pregnyl : Subcutaneous injection 5000 IU

All-Cause Mortality
A: >14 Follicles; GnRHa Trigger + 1500 hCG B: >14 Follicles; hCG Trigger C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 D: <15 Follicles; hCG Trigger
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
A: >14 Follicles; GnRHa Trigger + 1500 hCG B: >14 Follicles; hCG Trigger C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 D: <15 Follicles; hCG Trigger
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/58 (0.00%)   0/125 (0.00%)   0/141 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A: >14 Follicles; GnRHa Trigger + 1500 hCG B: >14 Follicles; hCG Trigger C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 D: <15 Follicles; hCG Trigger
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/58 (0.00%)   0/125 (0.00%)   0/141 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Peter Humaidan
Organization: Fertility Clinic Regional Hospital Skive
Phone: +45 78 44 57 60
EMail: peter.humaidan@viborg.rm.dk
Layout table for additonal information
Responsible Party: Peter Humaidan, Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier: NCT00627406     History of Changes
Other Study ID Numbers: N-VN-2002-0046MCH
First Submitted: February 22, 2008
First Posted: March 3, 2008
Results First Submitted: September 25, 2013
Results First Posted: November 27, 2013
Last Update Posted: November 27, 2013