Trial Outcomes & Findings for Triggering of Final Oocyte Maturation With GnRHa (Buserelin) in GnRH Antagonist Cycles (NCT NCT00627406)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

384 participants

Primary outcome timeframe

From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test

Results posted on

2013-11-27

Participant Flow

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

Participant milestones

Participant milestones
Measure	A: >14 Follicles; GnRHa Trigger + 1500 hCG 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	B: >14 Follicles; hCG Trigger 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	C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 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	D: <15 Follicles; hCG Trigger 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 Study STARTED	60	58	125	141
Overall Study COMPLETED	60	58	125	141
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A: >14 Follicles; GnRHa Trigger + 1500 hCG n=60 Participants 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	B: >14 Follicles; hCG Trigger n=58 Participants 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	C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 n=125 Participants 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	D: <15 Follicles; hCG Trigger n=141 Participants 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 n=384 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants	58 Participants n=7 Participants	125 Participants n=5 Participants	141 Participants n=4 Participants	384 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age Continuous	28.5 years STANDARD_DEVIATION 5.2 • n=5 Participants	29.8 years STANDARD_DEVIATION 3.8 • n=7 Participants	30.8 years STANDARD_DEVIATION 3.9 • n=5 Participants	31.5 years STANDARD_DEVIATION 3.7 • n=4 Participants	30.2 years STANDARD_DEVIATION 4.0 • n=21 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	58 Participants n=7 Participants	125 Participants n=5 Participants	141 Participants n=4 Participants	384 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment Denmark	60 participants n=5 Participants	58 participants n=7 Participants	125 participants n=5 Participants	141 participants n=4 Participants	384 participants n=21 Participants

PRIMARY outcome

Timeframe: From the date of triggering ovulation until 2 weeks after pregnancy test. group C and D. 12 days after pregnancy test

Population: No power calculation was proformed.

Outcome measures

Outcome measures
Measure	A: >14 Follicles; GnRHa Trigger + 1500 hCG n=60 Participants 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	B: >14 Follicles; hCG Trigger n=58 Participants 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	C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 n=125 Participants 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	D: <15 Follicles; hCG Trigger n=141 Participants 14 or less follicles with a diameter of \> 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.) Pregnyl : Subcutaneous injection 5000 IU
Frequency of Moderate to Severe OHSS.	0 participants	2 participants	2 participants	0 participants

SECONDARY outcome

Timeframe: from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test

Outcome measures

Outcome measures
Measure	A: >14 Follicles; GnRHa Trigger + 1500 hCG n=60 Participants 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	B: >14 Follicles; hCG Trigger n=58 Participants 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	C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2 n=125 Participants 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	D: <15 Follicles; hCG Trigger n=141 Participants 14 or less follicles with a diameter of \> 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.) Pregnyl : Subcutaneous injection 5000 IU
Pregnancy Rate	17 participants	15 participants	37 participants	36 participants

Adverse Events

A: >14 Follicles; GnRHa Trigger + 1500 hCG

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B: >14 Follicles; hCG Trigger

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

D: <15 Follicles; hCG Trigger

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Peter Humaidan

Fertility Clinic Regional Hospital Skive

Phone: +45 78 44 57 60

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place