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

NCT02449889 | Completed Phase 3 Results DMC

• 1 other identifier: 000191
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of Metaphase II (MII) Oocytes

  Prior to insemination (within 6 hours after oocyte retrieval)

• Number of Fertilized (2 Pronuclei (2PN)) Oocytes

  One day after oocyte retrieval

• Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate

  13-15 days after transfer

• Clinical Pregnancy Rate

  5-6 weeks after transfer

• Frequency of Adverse Events (AEs)

  AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented

Study Arms (3)

HP-hCG IM

EXPERIMENTAL

highly purified human chorionic gonadotropin, intramuscularly (IM)

Drug: highly purified human chorionic gonadotropin

HP-hCG SC

EXPERIMENTAL

highly purified human chorionic gonadotropin, subcutaneously (SC)

Drug: highly purified human chorionic gonadotropin

rhCG

ACTIVE COMPARATOR

recombinant human chorionic gonadotropin

Drug: recombinant human chorionic gonadotropin

Interventions

highly purified human chorionic gonadotropin DRUG

Also known as: CHORAPUR, BREVACTID

HP-hCG IM; HP-hCG SC

recombinant human chorionic gonadotropin DRUG

Also known as: OVIDREL, OVITRELLE

rhCG

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Instituto Ideia Fértil de Saúde Reproductive (there may be other sites in this country)

São Paulo, Brazil

Location

MeSH Terms

Conditions

Infertility

Interventions

Chorionic Gonadotropin; Ovidrel

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Results Point of Contact

• Title: Global Clinical Compliance
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2015
• First Posted: May 20, 2015
• Study Start: April 1, 2016
• Primary Completion: July 9, 2017
• Study Completion: March 1, 2018
• Last Updated: June 26, 2019
• Results First Posted: June 10, 2019

Record last verified: 2019-06

Locations

BR (1)