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

Infertility Clinical Trial

— FASHION  

Official title:

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Comparing 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02449889
• Other study ID #: 000191
• Status: Completed
• Phase: Phase 3
• Start date: April 2016
• Est. completion date: March 1, 2018

Study information

• Verified date: June 2019
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: March 1, 2018
• Est. primary completion date: July 9, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• highly purified human chorionic gonadotropin

• recombinant human chorionic gonadotropin

Locations

Country	Name	City	State
Brazil	Instituto Ideia Fértil de Saúde Reproductive (there may be other sites in this country)	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Oocytes Retrieved	Oocyte retrieval took place 36 h (±2h) after hCG administration. At oocyte retrieval the number of oocytes retrieved was recorded.	Approximately 36 hours after hCG administration
Secondary	Number of Metaphase II (MII) Oocytes	Only applicable for insemination using intracytoplasmic sperm injection (ICSI). The MII oocytes were counted prior to insemination.	Prior to insemination (within 6 hours after oocyte retrieval)
Secondary	Number of Fertilized (2 Pronuclei (2PN)) Oocytes	Fertilization was assessed by counting the number of pronuclei, which was recorded as 0, 1, 2 or >2. Correct fertilization was defined as oocytes with 2PN.	One day after oocyte retrieval
Secondary	Positive ß Unit of Human Chorionic Gonadotropin (ßhCG) Rate	Defined as percentage of subjects with positive beta hCG. A positive ß hCG was confirmed by a blood test obtained 13-15 days after transfer.	13-15 days after transfer
Secondary	Clinical Pregnancy Rate	Defined as percentage of subjects with clinical pregnancy. Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.	5-6 weeks after transfer
Secondary	Frequency of Adverse Events (AEs)	The number of treatment-emergent AEs (TEAEs) in each treatment group will be presented.	AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented
Secondary	Intensity of AEs	The intensity of an TEAE would be classified using the following 3-point scale: mild (awareness of signs or symptoms, but no disruption of usual activity), moderate (event sufficient to affect usual activity [disturbing]) or severe (inability to work or perform usual activities [unacceptable]).	AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented.