Comparison Between Recombinant Versus Urinary hCG for Ovulation Induction in High Responders

January 18, 2016 updated by: Eugonia

Recombinant hCG (Ovitrelle) Vesrus Urinary hCG (Pregnyl) for Triggering Final Oocyte Maturation in High Responders

The purpose of this study is to compare the clinical outcomes of recombinant human chorionic gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Urinary human chorionic gonadotrophin (u-hCG) has been widely used to induce final oocyte maturation and to trigger ovulation in assisted conception. Recombinant technology has allowed the production of r-hCG inj which all urinary contaminants are absent. Hence, this would allow the safe subcutaneous administration of a compound with less batch-to-batch variation. This study will investigate the effectiveness of the recombinant hCG compared to the currently used urinary hCG.

Study Type

Interventional

Enrollment (Actual)

150

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

  • Greece
      • Athens, Greece, 11528
        • Eugonia

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

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • At least 14 follicles >11mm on the day of triggering final oocyte maturation
  • Pretreated with GnRH antagonist protocol

Exclusion Criteria:

  • Poor responders
  • Women with 25 or more follicles on the day of trigger

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: rHCG 250 ug
Injection of 250 ug Ovitrelle to trigger final oocyte maturation
Drug: rHCG 250ug
Injection of 250 ug Ovitrelle to trigger final oocyte maturation
Other Names:
  • Ovitrelle
ACTIVE_COMPARATOR: uHCG 5000 IU
Injection of 5000 IU Pregnyl to trigger final oocyte maturation
Drug: uHCG 5000 IU
Injection of 5000 IU Pregnyl to trigger final oocyte maturation
Other Names:
  • Pregnyl 5000 IU
ACTIVE_COMPARATOR: uHCG 7500 IU
Injection of 7500 IU Pregnyl to trigger final oocyte maturation
Drug: uHCG 7500 IU
Injection of 7500 IU Pregnyl to trigger final oocyte maturation
Other Names:
  • Pregnyl 7500 IU

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of mature oocytes
Time Frame: Day of oocyte retrieval (Day 0)
Percentage MII/COCs
Day of oocyte retrieval (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive test per embryo transfer
Time Frame: 15 days post oocyte retrieval
15 days post oocyte retrieval
Clinical pregnancy per embryo transfer
Time Frame: 7 weeks of gestation
7 weeks of gestation
Ongoing pregnancy per embryo transfer
Time Frame: 12 weeks of gestation
12 weeks of gestation
Level of serum hCG on day of oocyte retrieval
Time Frame: Day of oocyte retrieval
Day of oocyte retrieval
Number of oocytes (COC) retrieved
Time Frame: Day of oocyte retrieval
Day of oocyte retrieval
Number of mature oocytes (MII)
Time Frame: Day of oocyte retrieval
Day of oocyte retrieval
Oocyte retrieval rate
Time Frame: Day of oocyte retrieval (Day 0)
Number of oocytes retrieved/number of follicles on the day of triggering final oocyte maturation
Day of oocyte retrieval (Day 0)
Incidence of severe early OHSS
Time Frame: up to Day 5 post oocyte retrieval
up to Day 5 post oocyte retrieval

Collaborators and Investigators

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

Sponsor

Eugonia

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

June 1, 2013

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ANTICIPATED)

July 1, 2016

Study Registration Dates

First Submitted

December 22, 2006

First Submitted That Met QC Criteria

December 23, 2006

First Posted (ESTIMATE)

December 25, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 18, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ovitrelle vs pregnyl

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.

Clinical Trials on Infertility

Clinical Trials on rHCG 250ug

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe