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 logo

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

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

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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