Trial · Interventional

CompletedPhase 4Results postedRegistry data

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

NCTNCT00627406Other idN-VN-2002-0046MCH

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 4
Enrollment: 384 participants (actual)
Sponsor: Regionshospitalet Viborg, Skive · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Denmark
Start: Jan 2009
Primary completion: Dec 2011
Completion: Dec 2011
First posted: 3 Mar 2008 (estimated)
Last update posted: 27 Nov 2013 (estimated)
Conditions: OHSS (Ovarian Hyperstimulation)

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2009201020112012

Ph 4
Triggering of Final Oocyte Maturation With GnRHa (Buserelin) in GnRH Antagonist Cycles
NCT00627406
Jan 2009 to Dec 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Buserelin and PregnylDrug
PregnylDrug
Buserelin and PregnylDrug
PregnylDrug

Arms4

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)
Active comparator
B
More than 14 follicles with a diameter of \> 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)
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)
Active comparator
D
14 or less follicles with a diameter of \> 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)

Primary outcomes1

Outcomes the sponsor listed as 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

Secondary outcomes(1)

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

Frequency of Moderate to Severe OHSS.

Group	Value (participants)
A: >14 Follicles; GnRHa Trigger + 1500 hCG	0
B: >14 Follicles; hCG Trigger	2
C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2	2
D: <15 Follicles; hCG Trigger	0

Secondary and other outcome results(1)

Secondary outcomeNumber· from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test

Pregnancy Rate

Group	Value (participants)
A: >14 Follicles; GnRHa Trigger + 1500 hCG	17
B: >14 Follicles; hCG Trigger	15
C:<15 Follicles; GnRHa Trigger + 1500 hCG x 2	37
D: <15 Follicles; hCG Trigger	36

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
A: >14 Follicles; GnRHa Trigger + 1500 hCGMore 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	–	0 / 60	0 / 60
B: >14 Follicles; hCG TriggerMore than 14 follicles with a diameter of \> 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.) Pregnyl : Subcutaneous injection 5000 IU	–	0 / 58	0 / 58
C:<15 Follicles; GnRHa Trigger + 1500 hCG x 214 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	–	0 / 125	0 / 125
D: <15 Follicles; hCG Trigger14 or less follicles with a diameter of \> 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.) Pregnyl : Subcutaneous injection 5000 IU	–	0 / 141	0 / 141

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedHumaidan P, Polyzos NP, Alsbjerg B, Erb K, Mikkelsen AL, Elbaek HO, Papanikolaou EG, Andersen CY. GnRHa trigger and individualized luteal phase hCG support according to ovarian response to stimulation: two prospective randomized controlled multi-centre studies in IVF patients. Hum Reprod. 2013 Sep;28(9):2511-21. doi: 10.1093/humrep/det249. Epub 2013 Jun 9. PMID 23753114

Eligibility

Who could join, as posted.

Sex: Female
Age: from 20 Years up to 39 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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