A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation (FASHION)

Ferring

Status and phase: Completed; Phase 3

Conditions: Infertility

Treatments: Drug: highly purified human chorionic gonadotropin; Drug: recombinant human chorionic gonadotropin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02449889

000191

Details and patient eligibility

About

This trial is investigating the efficacy and safety of highly purified human chorionic gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of final follicular maturation in women undergoing controlled ovarian stimulation

Enrollment: 176 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre-menopausal females between the ages of 18 and 39 years
• Documented history of infertility
• Body mass index (BMI) between 17.5 and 32.0 kg/m2
• Regular menstrual cycles

Exclusion criteria

• Known endometriosis stage III and IV
• Known polycystic ovarian syndrome (PCOS)
• History of recurrent miscarriage
• History of more than three previous controlled ovarian stimulation cycles

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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176 participants in 3 patient groups

HP-hCG IM

Experimental group

Description:

highly purified human chorionic gonadotropin, intramuscularly (IM)

Treatment:

Drug: highly purified human chorionic gonadotropin

HP-hCG SC

Experimental group

Description:

highly purified human chorionic gonadotropin, subcutaneously (SC)

Treatment:

Drug: highly purified human chorionic gonadotropin

rhCG

Active Comparator group

Description:

recombinant human chorionic gonadotropin

Treatment:

Drug: recombinant human chorionic gonadotropin