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

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)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00627406
Enrollment
384
Registered
2008-03-03
Start date
2009-01-31
Completion date
2011-12-31
Last updated
2013-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OHSS (Ovarian Hyperstimulation)

Keywords

GnRH antagonist, GnRH agonist, hCG, OHSS, In vitro fertilization, ovulation induction, Clinical pregnancy rate

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

Interventions

DRUGBuserelin and Pregnyl

Subcutaneous injection 0.5 mg and 1500 IU

DRUGPregnyl

Subcutaneous injection 5000 IU

Sponsors

Regionshospitalet Viborg, Skive
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 39 Years
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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Pregnancy Ratefrom stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test

Countries

Denmark

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.

Participants by arm

ArmCount
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
60
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
58
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
125
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
141
Total384

Baseline characteristics

CharacteristicB: >14 Follicles; hCG TriggerC:<15 Follicles; GnRHa Trigger + 1500 hCG x 2A: >14 Follicles; GnRHa Trigger + 1500 hCGD: <15 Follicles; hCG TriggerTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
58 Participants125 Participants60 Participants141 Participants384 Participants
Age Continuous29.8 years
STANDARD_DEVIATION 3.8
30.8 years
STANDARD_DEVIATION 3.9
28.5 years
STANDARD_DEVIATION 5.2
31.5 years
STANDARD_DEVIATION 3.7
30.2 years
STANDARD_DEVIATION 4
Region of Enrollment
Denmark
58 participants125 participants60 participants141 participants384 participants
Sex: Female, Male
Female
58 Participants125 Participants60 Participants141 Participants384 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 600 / 580 / 1250 / 141
serious
Total, serious adverse events
0 / 600 / 580 / 1250 / 141

Outcome results

Primary

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

Population: No power calculation was proformed.

ArmMeasureValue (NUMBER)
A: >14 Follicles; GnRHa Trigger + 1500 hCGFrequency of Moderate to Severe OHSS.0 participants
B: >14 Follicles; hCG TriggerFrequency of Moderate to Severe OHSS.2 participants
C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2Frequency of Moderate to Severe OHSS.2 participants
D: <15 Follicles; hCG TriggerFrequency of Moderate to Severe OHSS.0 participants
Secondary

Pregnancy Rate

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

ArmMeasureValue (NUMBER)
A: >14 Follicles; GnRHa Trigger + 1500 hCGPregnancy Rate17 participants
B: >14 Follicles; hCG TriggerPregnancy Rate15 participants
C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2Pregnancy Rate37 participants
D: <15 Follicles; hCG TriggerPregnancy Rate36 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026