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

Eugonia

Status and phase: Unknown; Phase 4

Conditions: Infertility

Treatments: Drug: uHCG 5000 IU; Drug: uHCG 7500 IU; Drug: rHCG 250ug

Study type: Interventional

Funder types: Other

Identifiers

NCT00415766

ovitrelle vs pregnyl

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

rHCG 250 ug

Active Comparator group

Description:

Injection of 250 ug Ovitrelle to trigger final oocyte maturation

Treatment:

Drug: rHCG 250ug

uHCG 5000 IU

Active Comparator group

Description:

Injection of 5000 IU Pregnyl to trigger final oocyte maturation

Treatment:

Drug: uHCG 5000 IU

uHCG 7500 IU

Active Comparator group

Description:

Injection of 7500 IU Pregnyl to trigger final oocyte maturation

Treatment:

Drug: uHCG 7500 IU