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

NCT ID: NCT00627406

Last Updated: 2013-11-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

Detailed Description

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Conditions

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OHSS (Ovarian Hyperstimulation)

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Buserelin and Pregnyl

Intervention Type DRUG

Subcutaneous injection 0.5 mg and 1500 IU

B

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

Group Type ACTIVE_COMPARATOR

Pregnyl

Intervention Type DRUG

Subcutaneous injection 5000 IU

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)

Group Type EXPERIMENTAL

Buserelin and Pregnyl

Intervention Type DRUG

Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days

D

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

Group Type ACTIVE_COMPARATOR

Pregnyl

Intervention Type DRUG

Subcutaneous injection 5000 IU

Interventions

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Buserelin and Pregnyl

Subcutaneous injection 0.5 mg and 1500 IU

Intervention Type DRUG

Pregnyl

Subcutaneous injection 5000 IU

Intervention Type DRUG

Buserelin and Pregnyl

Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days

Intervention Type DRUG

Pregnyl

Subcutaneous injection 5000 IU

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Regionshospitalet Viborg, Skive

OTHER

Sponsor Role lead

Responsible Party

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Peter Humaidan

Prof. M.D. D.M.Sc.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter S Humaidan, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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The Fertility Clinic, Regional Hospital of Skive

Skive, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 23753114 (View on PubMed)

Other Identifiers

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N-VN-2002-0046MCH

Identifier Type: -

Identifier Source: org_study_id