Phase 3 N=176 Randomized Single-blind Treatment

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

Infertility

Bottom Line

View on ClinicalTrials.gov: NCT02449889 ↗

Enrolled (actual)

176

Serious AEs

2.3%

Results posted

Jun 2019

Primary outcome: Primary: Number of Oocytes Retrieved — 7.1; 7.3; 6.6 Number of oocytes

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: highly purified human chorionic gonadotropin (Drug); recombinant human chorionic gonadotropin (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Ferring Pharmaceuticals
Primary completion: Jul 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Oocytes Retrieved	7.1; 7.3; 6.6	—
SECONDARY Number of Metaphase II (MII) Oocytes	5.9; 6.2; 5.6	—
SECONDARY Number of Fertilized (2 Pronuclei (2PN)) Oocytes	4.4; 4.7; 4.2	—
SECONDARY Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate	50.0; 37.9; 36.7	—
SECONDARY Clinical Pregnancy Rate	46.6; 27.6; 31.7	—
SECONDARY Frequency of Adverse Events (AEs)	22; 25; 25	—
SECONDARY Intensity of AEs	14; 18; 22; 8; 6; 3	—

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02449889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.