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

• Sponsor: Regionshospitalet Viborg, Skive (Other)
• Overall Status: Completed
• CT.gov ID: NCT00627406
• Collaborator: (none)
• Enrollment: 384
• Location: 1
• Arms: 4
• Duration (Months): 35
• Patients Per Site Per Month: 11

Study Details

Study Description

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; Drug: Buserelin and Pregnyl; Drug: Pregnyl	Phase 4

Study Design

• Study Type: Interventional
• 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: Jan 1, 2009
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 Measures

1. Pregnancy Rate [from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 39 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	The Fertility Clinic, Regional Hospital of Skive	Skive		Denmark	7800

Sponsors and Collaborators

• Regionshospitalet Viborg, Skive

Investigators

• Principal Investigator: Peter S Humaidan, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Humaidan, Prof. M.D. D.M.Sc., Regionshospitalet Viborg, Skive
• ClinicalTrials.gov Identifier: NCT00627406
• Other Study ID Numbers: N-VN-2002-0046MCH
• First Posted: Mar 3, 2008
• Last Update Posted: Nov 27, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Peter Humaidan, Prof. M.D. D.M.Sc., Regionshospitalet Viborg, Skive: GnRH antagonist; GnRH agonist; hCG; OHSS; In vitro fertilization; ovulation induction; Clinical pregnancy rate
• Additional relevant MeSH terms: Chorionic Gonadotropin; Buserelin

Study Results

Participant Flow

Recruitment Details	Recruitment period from jan. 2009 to dec. 2011. Participanting Clinics Fertility clinic Regional Hospital Skive, University Hostipal Odense, Regional Hospital Holbaek, Denmark.

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
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

Baseline Characteristics

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
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 Participants	60	58	125	141	384
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	60 100%	58 100%	125 100%	141 100%	384 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.5 (5.2)	29.8 (3.8)	30.8 (3.9)	31.5 (3.7)	30.2 (4.0)
Sex: Female, Male (Count of Participants)
Female	60 100%	58 100%	125 100%	141 100%	384 100%
Male	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Denmark	60 100%	58 100%	125 100%	141 100%	384 100%

Outcome Measures

1. Primary Outcome

Title	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

Outcome Measure Data

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
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
Measure Participants	60	58	125	141
Number [participants]	0 0%	2 3.4%	2 1.6%	0 0%

2. Secondary Outcome

Title	Pregnancy Rate
Time Frame	from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test

Outcome Measure Data

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
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
Measure Participants	60	58	125	141
Number [participants]	17 28.3%	15 25.9%	37 29.6%	36 25.5%

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/58 (0%)		0/125 (0%)		0/141 (0%)
Other (Not Including 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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/58 (0%)		0/125 (0%)		0/141 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.