Safety and efficacy of mixing cetrorelix with follitropin alfa: a randomized study.
OBJECTIVE
To assess the safety and efficacy of mixing cetrorelix with follitropin alfa (rFSH) in assisted reproductive technology.


METHODS
Prospective, randomized study.


METHODS
An IVF center in a teaching hospital.


METHODS
One hundred forty patients undergoing intracytoplasmic sperm injection were randomized into mixed (M) or separate (S) injection groups.


METHODS
In the M group, rFSH and cetrorelix were mixed immediately before administration, whereas in the S group, rFSH and cetrorelix were administered separately.


METHODS
The primary efficacy end point was the incidence of premature LH surge. The secondary efficacy endpoints included estradiol levels on the day of hCG injection, numbers of oocytes obtained, implantation, and ongoing pregnancy rates. The safety endpoints included ovarian hyperstimulation syndrome, and adverse events related to injections including local tolerability.


RESULTS
Excluding eight patients who dropped out of the study, there were 66 patients in each group for analysis. Patients in the M group received significantly fewer injections than patients in the S group (9.1 vs. 13.9). Other outcome parameters, including incidences of premature LH surge, numbers of oocytes retrieved, fertilization, implantation, and ongoing pregnancy rates were similar between the two groups.


CONCLUSIONS
Cetrorelix and rFSH can be mixed together without compromising their reported safety and efficacy. This observation is in line with the reported safety and efficacy profile of the products listed in their current package inserts.
Lin
Yu-Hung
YH
Department of Obstetrics and Gynecology, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan, Republic of China.
Wen
Yeong-Ray
YR
Chang
Yuanmay
Y
Seow
Kok-Min
KM
Hsieh
Bih-Chwen
BC
Hwang
Jiann-Loung
JL
Tzeng
Chii-Ruey
CR