Efficacy of Pergoveris in Aged IVF Patients

Launched by VIETNAM NATIONAL UNIVERSITY · Sep 18, 2014

Keywords

ClinConnect Summary

A randomized controlled single center study.

Based on the difference of 19.1% in the clinical pregnancy rate between the two treatment groups, with and without LH supplementation, in a previous study, with 90% power and a 2-sided P-value of 0.05, the number of subjects required was 109 per group (total 218). The recruitment target was 120 subjects per group (total 240) to allow for dropouts.

Eligible subjects were randomized in blocks of 4 via a computer generated random number list to either the Pergoveris arm or the follitropin alpha arm.

Ovarian stimulation was performed by using GnRH...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • age ≥ 35 years
• • body mass index \<28 kg/m2
• • had ≤ 3 previous IVF attempts
• • receiving a GnRH-antagonist protocol
• • agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
• • have given written informed consent with the understanding that the subject may withdraw consent at any time
• Exclusion Criteria:
• • participating in another interventional clinical trial
• • PCOS or WHO group 1
• • have uterine abnormalities
• • have endocrine disorders such as hyperprolactinemia, thyroid disorders