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

NCT ID: NCT00415766

Last Updated: 2016-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Infertility

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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rHCG 250 ug

Injection of 250 ug Ovitrelle to trigger final oocyte maturation

Group Type ACTIVE_COMPARATOR

rHCG 250ug

Intervention Type DRUG

Injection of 250 ug Ovitrelle to trigger final oocyte maturation

uHCG 5000 IU

Injection of 5000 IU Pregnyl to trigger final oocyte maturation

Group Type ACTIVE_COMPARATOR

uHCG 5000 IU

Intervention Type DRUG

Injection of 5000 IU Pregnyl to trigger final oocyte maturation

uHCG 7500 IU

Injection of 7500 IU Pregnyl to trigger final oocyte maturation

Group Type ACTIVE_COMPARATOR

uHCG 7500 IU

Intervention Type DRUG

Injection of 7500 IU Pregnyl to trigger final oocyte maturation

Interventions

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rHCG 250ug

Injection of 250 ug Ovitrelle to trigger final oocyte maturation

Intervention Type DRUG

uHCG 5000 IU

Injection of 5000 IU Pregnyl to trigger final oocyte maturation

Intervention Type DRUG

uHCG 7500 IU

Injection of 7500 IU Pregnyl to trigger final oocyte maturation

Intervention Type DRUG

Other Intervention Names

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Ovitrelle Pregnyl 5000 IU Pregnyl 7500 IU

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Eugonia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tryfon Lainas, PhD

Role: PRINCIPAL_INVESTIGATOR

Eugonia

Locations

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Eugonia

Athens, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 16848893 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15846677 (View on PubMed)

Other Identifiers

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ovitrelle vs pregnyl

Identifier Type: -

Identifier Source: org_study_id

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