Back to results

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

Primary Purpose

Infertility

Status

Unknown status

Phase

Phase 4

Locations

Greece

Study Type

Interventional

Intervention

rHCG 250ug

uHCG 5000 IU

uHCG 7500 IU

About this trial

This is an interventional treatment trial for Infertility focused on measuring recombinant hCG, urinary hCG

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Eugonia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

rHCG 250 ug

uHCG 5000 IU

uHCG 7500 IU

Arm Description

Injection of 250 ug Ovitrelle to trigger final oocyte maturation

Injection of 5000 IU Pregnyl to trigger final oocyte maturation

Injection of 7500 IU Pregnyl to trigger final oocyte maturation

Outcomes

Primary Outcome Measures

Percentage of mature oocytes

Percentage MII/COCs

Secondary Outcome Measures

Positive test per embryo transfer

Clinical pregnancy per embryo transfer

Ongoing pregnancy per embryo transfer

Level of serum hCG on day of oocyte retrieval

Number of oocytes (COC) retrieved

Number of mature oocytes (MII)

Oocyte retrieval rate

Number of oocytes retrieved/number of follicles on the day of triggering final oocyte maturation

Incidence of severe early OHSS

Full Information

NCT ID

NCT00415766

First Posted

December 22, 2006

Last Updated

January 18, 2016

Sponsor

Eugonia

1. Study Identification

Unique Protocol Identification Number

NCT00415766

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2013 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eugonia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

recombinant hCG, urinary hCG

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

rHCG 250 ug

Arm Type

Active Comparator

Arm Description

Injection of 250 ug Ovitrelle to trigger final oocyte maturation

Arm Title

uHCG 5000 IU

Arm Type

Active Comparator

Arm Description

Injection of 5000 IU Pregnyl to trigger final oocyte maturation

Arm Title

uHCG 7500 IU

Arm Type

Active Comparator

Arm Description

Injection of 7500 IU Pregnyl to trigger final oocyte maturation

Intervention Type

Drug

Intervention Name(s)

rHCG 250ug

Other Intervention Name(s)

Ovitrelle

Intervention Description

Injection of 250 ug Ovitrelle to trigger final oocyte maturation

Intervention Type

Drug

Intervention Name(s)

uHCG 5000 IU

Other Intervention Name(s)

Pregnyl 5000 IU

Intervention Description

Injection of 5000 IU Pregnyl to trigger final oocyte maturation

Intervention Type

Drug

Intervention Name(s)

uHCG 7500 IU

Other Intervention Name(s)

Pregnyl 7500 IU

Intervention Description

Injection of 7500 IU Pregnyl to trigger final oocyte maturation

Primary Outcome Measure Information:

Title

Percentage of mature oocytes

Description

Percentage MII/COCs

Time Frame

Day of oocyte retrieval (Day 0)

Secondary Outcome Measure Information:

Title

Positive test per embryo transfer

Time Frame

15 days post oocyte retrieval

Title

Clinical pregnancy per embryo transfer

Time Frame

7 weeks of gestation

Title

Ongoing pregnancy per embryo transfer

Time Frame

12 weeks of gestation

Title

Level of serum hCG on day of oocyte retrieval

Time Frame

Day of oocyte retrieval

Title

Number of oocytes (COC) retrieved

Time Frame

Day of oocyte retrieval

Title

Number of mature oocytes (MII)

Time Frame

Day of oocyte retrieval

Title

Oocyte retrieval rate

Description

Number of oocytes retrieved/number of follicles on the day of triggering final oocyte maturation

Time Frame

Day of oocyte retrieval (Day 0)

Title

Incidence of severe early OHSS

Time Frame

up to Day 5 post oocyte retrieval

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tryfon Lainas, PhD

Organizational Affiliation

Eugonia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Eugonia

City

Athens

ZIP/Postal Code

11528

Country

Greece

12. IPD Sharing Statement

Citations:

PubMed Identifier

16848893

Citation

Revelli A, Poso F, Gennarelli G, Moffa F, Grassi G, Massobrio M. Recombinant versus highly-purified, urinary follicle-stimulating hormone (r-FSH vs. HP-uFSH) in ovulation induction: a prospective, randomized study with cost-minimization analysis. Reprod Biol Endocrinol. 2006 Jul 18;4:38. doi: 10.1186/1477-7827-4-38.

Results Reference

background

PubMed Identifier

15846677

Citation

Al-Inany HG, Aboulghar M, Mansour R, Proctor M. Recombinant versus urinary human chorionic gonadotrophin for ovulation induction in assisted conception. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003719. doi: 10.1002/14651858.CD003719.pub2.

Results Reference

background

Learn more about this trial

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

We'll reach out to this number within 24 hrs