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

September 25, 2013 updated by: Peter Humaidan, Regionshospitalet Viborg, Skive

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

384

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Skive, Denmark, 7800
        • The Fertility Clinic, Regional Hospital of Skive

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Drug: Buserelin and Pregnyl
Subcutaneous injection 0.5 mg and 1500 IU
Drug: Buserelin and Pregnyl
Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days
Active Comparator: B
More than 14 follicles with a diameter of > 11mm: triggering of ovulation with hCG (Pregnyl) 5.000 IU (s.c.)
Drug: Pregnyl
Subcutaneous injection 5000 IU
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)
Drug: Buserelin and Pregnyl
Subcutaneous injection 0.5 mg and 1500 IU
Drug: Buserelin and Pregnyl
Subcutaneous injection 0,5 mg and 1500 IU + 1500 IU after 7 days
Active Comparator: D
14 or less follicles with a diameter of > 11mm: triggering of ovulation with 5000 IU hCG (Pregnyl) (s.c.)
Drug: Pregnyl
Subcutaneous injection 5000 IU

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Pregnancy Rate
Time Frame: from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test
from stimulation day 1 until last ultrasound scan 7 weeks after a positive pregnancy test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regionshospitalet Viborg, Skive

Investigators

  • Principal Investigator: Peter S Humaidan, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

February 22, 2008

First Submitted That Met QC Criteria

February 29, 2008

First Posted (Estimate)

March 3, 2008

Study Record Updates

Last Update Posted (Estimate)

November 27, 2013

Last Update Submitted That Met QC Criteria

September 25, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-VN-2002-0046MCH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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