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

Phase 3

Completed

• Conditions: Infertility
• Interventions: Drug: recombinant human chorionic gonadotropin; Drug: highly purified human chorionic gonadotropin

• Registration Number: NCT02449889
• Lead Sponsor: Ferring Pharmaceuticals

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-20
• Study Start: 2016-04
• Primary Completion: 2017-07-09
• Study Completion: 2018-03-01
• Results First Submitted: 2018-10-12
• Results First Submitted QC: 2019-03-11
• Status Verified: 2019-06
• Results First Posted: 2019-06-10
• Last Update Submitted: 2019-06-17
• Last Update Posted: 2019-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rhCG	recombinant human chorionic gonadotropin	recombinant human chorionic gonadotropin
HP-hCG IM	highly purified human chorionic gonadotropin	highly purified human chorionic gonadotropin, intramuscularly (IM)
HP-hCG SC	highly purified human chorionic gonadotropin	highly purified human chorionic gonadotropin, subcutaneously (SC)

Primary Outcome Measures

Name	Time	Method
Number of Oocytes Retrieved	Approximately 36 hours after hCG administration	Oocyte retrieval took place 36 h (±2h) after hCG administration. At oocyte retrieval the number of oocytes retrieved was recorded.

Secondary Outcome Measures

Name	Time	Method
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	The number of treatment-emergent AEs (TEAEs) in each treatment group will be presented.
Number of Metaphase II (MII) Oocytes	Prior to insemination (within 6 hours after oocyte retrieval)	Only applicable for insemination using intracytoplasmic sperm injection (ICSI). The MII oocytes were counted prior to insemination.
Intensity of AEs	AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented.	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 \[unacceptable\]).
Number of Fertilized (2 Pronuclei (2PN)) Oocytes	One day after oocyte retrieval	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.
Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate	13-15 days after transfer	Defined as percentage of subjects with positive beta hCG. A positive β hCG was confirmed by a blood test obtained 13-15 days after transfer.
Clinical Pregnancy Rate	5-6 weeks after transfer	Defined as percentage of subjects with clinical pregnancy. Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer.

Trial Locations

Locations (1)

Instituto Ideia Fértil de Saúde Reproductive (there may be other sites in this country); 🇧🇷 São Paulo, Brazil