NCT00627406

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2008

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2 years until next milestone

Results Posted

Study results publicly available

November 27, 2013

Completed
Last Updated

November 27, 2013

Status Verified

September 1, 2013

Enrollment Period

2.9 years

First QC Date

February 22, 2008

Results QC Date

September 25, 2013

Last Update Submit

September 25, 2013

Conditions

OHSS (Ovarian Hyperstimulation)

Keywords

GnRH antagonistGnRH agonisthCGOHSSIn vitro fertilizationovulation inductionClinical pregnancy rate

Outcome Measures

Primary Outcomes (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 Outcomes (1)

  • Pregnancy Rate

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

Study Arms (4)

A

EXPERIMENTAL

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

B

ACTIVE COMPARATOR

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

Drug: Pregnyl

C

EXPERIMENTAL

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

D

ACTIVE COMPARATOR

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

Drug: Pregnyl

Interventions

Buserelin and PregnylDRUG

Subcutaneous injection 0.5 mg and 1500 IU

A
PregnylDRUG

Subcutaneous injection 5000 IU

B

Eligibility Criteria

Age20 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Significant disturbances in the woman (diabetes, epilepsy, liver/renal/heart disease, metabolic disorder)
  • Patients with \> 25 follicles on the day of triggering ovulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fertility Clinic, Regional Hospital of Skive

Skive, 7800, Denmark

Location

Related Publications (1)

  • Humaidan 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: 23753114DERIVED

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Interventions

BuserelinChorionic Gonadotropin

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsGonadotropinsPlacental HormonesPregnancy Proteins

Results Point of Contact

Title
Dr. Peter Humaidan
Organization
Fertility Clinic Regional Hospital Skive
peter.humaidan@viborg.rm.dk
+45 78 44 57 60

Study Officials

  • Peter S Humaidan, MD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. M.D. D.M.Sc.

Study Record Dates

First Submitted

February 22, 2008

First Posted

March 3, 2008

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

November 27, 2013

Results First Posted

November 27, 2013

Record last verified: 2013-09

Locations

DK(1)