OBJECTIVE: To demonstrate that highly purified human menopausal gonadotropin (HP-hMG) is as efficient and safe as recombinant FSH in females undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) treatment cycles. DESIGN: Multinational, open label, randomized, parallel group, comparative phase III trial. SETTING:In 22 centers across six countries; Belgium (1 center), Germany (6 centers), Israel (6 centers), The Netherlands (2 centers), Switzerland (1 center) and the United Kingdom (6 centers). PATIENT(S): A total of 781 women were enrolled between May 1999 and November 2000. INTERVENTION(S): In the all-patients-treated population, 373 patients received HP-hMG and 354 received recombinant FSH. A long protocol GnRH agonist regimen was used. MAIN OUTCOME MEASURE(S): The primary end point was ongoing pregnancy rate following one IVF/ICSI treatment cycle. Safety was assessed as a secondary end point. RESULT(S): Ongoing pregnancy rates 10 weeks after ovum pickup in the per-protocol population were 25% (n = 85/344) in the HP-hMG group and 22% (n = 71/317) in the recombinant FSH group. The incidence of ovarian hyperstimulation syndrome, miscarriage, adverse events, and injection site reactions (tolerability) were similar in both treatment groups. CONCLUSION(S): We found HP-hMG to be as effective as recombinant FSH in terms of ongoing clinical pregnancy. Both treatments have a similar safety/tolerability profile.
RCT Entities:
OBJECTIVE: To demonstrate that highly purified human menopausal gonadotropin (HP-hMG) is as efficient and safe as recombinant FSH in females undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) treatment cycles. DESIGN: Multinational, open label, randomized, parallel group, comparative phase III trial. SETTING: In 22 centers across six countries; Belgium (1 center), Germany (6 centers), Israel (6 centers), The Netherlands (2 centers), Switzerland (1 center) and the United Kingdom (6 centers). PATIENT(S): A total of 781 women were enrolled between May 1999 and November 2000. INTERVENTION(S): In the all-patients-treated population, 373 patients received HP-hMG and 354 received recombinant FSH. A long protocol GnRH agonist regimen was used. MAIN OUTCOME MEASURE(S): The primary end point was ongoing pregnancy rate following one IVF/ICSI treatment cycle. Safety was assessed as a secondary end point. RESULT(S): Ongoing pregnancy rates 10 weeks after ovum pickup in the per-protocol population were 25% (n = 85/344) in the HP-hMG group and 22% (n = 71/317) in the recombinant FSH group. The incidence of ovarian hyperstimulation syndrome, miscarriage, adverse events, and injection site reactions (tolerability) were similar in both treatment groups. CONCLUSION(S): We found HP-hMG to be as effective as recombinant FSH in terms of ongoing clinical pregnancy. Both treatments have a similar safety/tolerability profile.
Authors: William R Keye; Bobby Webster; Richard Dickey; Stephen Somkuti; Jack Crain; M Joseph Scobey Journal: Reprod Biol Endocrinol Date: 2005-11-09 Impact factor: 5.211
Authors: Jared C Robins; Andrew F Khair; Eric A Widra; Michael M Alper; Winnie W Nelson; Eric D Foster; Anshul Sinha; Masakazu Ando; Patrick W Heiser; Gaurang S Daftary Journal: F S Rep Date: 2020-11-10