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Large, comparative, randomized double-blind trial confirming noninferiority of pregnancy rates for corifollitropin alfa compared with recombinant follicle-stimulating hormone in a gonadotropin-releasing hormone antagonist controlled ovarian stimulation protocol in older patients undergoing in vitro fertilization.
Fertil Steril. 2015 Jul; 104(1):94-103.e1.FS

Abstract

OBJECTIVE

To compare corifollitropin alfa with recombinant FSH treatment in terms of the vital pregnancy rate in older patients undergoing IVF.

DESIGN

Phase 3 randomized, double-blind, noninferiority trial.

SETTING

Multicenter trial.

PATIENT(S)

A total of 1,390 women aged 35-42 years.

INTERVENTION(S)

A single injection of 150 μg of corifollitropin alfa or daily 300 IU of recombinant FSH for the first 7 days then daily recombinant FSH until three follicles reach ≥17 mm in size. Ganirelix was started on stimulation day 5 up to and including the day of recombinant hCG administration. If available, two good quality embryos were transferred on day 3.

MAIN OUTCOME MEASURE(S)

Vital pregnancy rate (PR), number of oocytes, and live birth rate.

RESULT(S)

Vital PRs per started cycle were 23.9% in the corifollitropin alfa group and 26.9% in the recombinant FSH group, with an estimated difference (95% confidence interval) of -3.0% (-7.4 to 1.4). The mean (SD) number of recovered oocytes per started cycle was 10.7 (7.2) and 10.3 (6.8) in the corifollitropin alfa and the recombinant FSH groups, respectively, with an estimated difference of 0.5 (-0.2 to 1.2). The live birth rates per started cycle were 21.3% in the corifollitropin alfa group and 23.4% in the recombinant FSH group, with an estimated difference (95% confidence interval) -2.3% (-6.5 to 1.9). The incidence of serious adverse events was 0.4% versus 2.7% in the corifollitropin alfa and recombinant FSH groups, respectively, and of ovarian hyperstimulation syndrome (OHSS; all grades) was 1.7% in both groups.

CONCLUSION(S)

Treatment with corifollitropin alfa was proven noninferior to daily recombinant FSH with respect to vital PRs, number of oocytes retrieved, and live birth rates, and was generally well tolerated.

CLINICAL TRIAL REGISTRATION NUMBER

NCT01144416.

Authors+Show Affiliations

Huntington Reproductive Center, Encino, California. Electronic address: boostanfarivf@havingbabies.com.The Fertility Center of Las Vegas, Las Vegas, Nevada.Shady Grove Fertility, Rockville, Maryland.The Claudia Cohen and Ronald O. Perelman Center for Reproductive Medicine, Weill Cornell Medical College, New York, New York.MSD BV, Oss, the Netherlands.Merck & Co., Inc., Kenilworth, New Jersey.MSD BV, Oss, the Netherlands.Merck & Co., Inc., Kenilworth, New Jersey.MSD BV, Oss, the Netherlands.No affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26003273

Citation

Boostanfar, Robert, et al. "Large, Comparative, Randomized Double-blind Trial Confirming Noninferiority of Pregnancy Rates for Corifollitropin Alfa Compared With Recombinant Follicle-stimulating Hormone in a Gonadotropin-releasing Hormone Antagonist Controlled Ovarian Stimulation Protocol in Older Patients Undergoing in Vitro Fertilization." Fertility and Sterility, vol. 104, no. 1, 2015, pp. 94-103.e1.
Boostanfar R, Shapiro B, Levy M, et al. Large, comparative, randomized double-blind trial confirming noninferiority of pregnancy rates for corifollitropin alfa compared with recombinant follicle-stimulating hormone in a gonadotropin-releasing hormone antagonist controlled ovarian stimulation protocol in older patients undergoing in vitro fertilization. Fertil Steril. 2015;104(1):94-103.e1.
Boostanfar, R., Shapiro, B., Levy, M., Rosenwaks, Z., Witjes, H., Stegmann, B. J., Elbers, J., Gordon, K., & Mannaerts, B. (2015). Large, comparative, randomized double-blind trial confirming noninferiority of pregnancy rates for corifollitropin alfa compared with recombinant follicle-stimulating hormone in a gonadotropin-releasing hormone antagonist controlled ovarian stimulation protocol in older patients undergoing in vitro fertilization. Fertility and Sterility, 104(1), 94-e1. https://doi.org/10.1016/j.fertnstert.2015.04.018
Boostanfar R, et al. Large, Comparative, Randomized Double-blind Trial Confirming Noninferiority of Pregnancy Rates for Corifollitropin Alfa Compared With Recombinant Follicle-stimulating Hormone in a Gonadotropin-releasing Hormone Antagonist Controlled Ovarian Stimulation Protocol in Older Patients Undergoing in Vitro Fertilization. Fertil Steril. 2015;104(1):94-103.e1. PubMed PMID: 26003273.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Large, comparative, randomized double-blind trial confirming noninferiority of pregnancy rates for corifollitropin alfa compared with recombinant follicle-stimulating hormone in a gonadotropin-releasing hormone antagonist controlled ovarian stimulation protocol in older patients undergoing in vitro fertilization. AU - Boostanfar,Robert, AU - Shapiro,Bruce, AU - Levy,Michael, AU - Rosenwaks,Zev, AU - Witjes,Han, AU - Stegmann,Barbara J, AU - Elbers,Jolanda, AU - Gordon,Keith, AU - Mannaerts,Bernadette, AU - ,, Y1 - 2015/05/21/ PY - 2014/10/20/received PY - 2015/04/06/revised PY - 2015/04/15/accepted PY - 2015/5/25/entrez PY - 2015/5/25/pubmed PY - 2015/9/22/medline KW - Corifollitropin alfa KW - GnRH antagonist KW - assisted reproductive technology KW - recombinant FSH KW - women aged 35–42 years SP - 94 EP - 103.e1 JF - Fertility and sterility JO - Fertil. Steril. VL - 104 IS - 1 N2 - OBJECTIVE: To compare corifollitropin alfa with recombinant FSH treatment in terms of the vital pregnancy rate in older patients undergoing IVF. DESIGN: Phase 3 randomized, double-blind, noninferiority trial. SETTING: Multicenter trial. PATIENT(S): A total of 1,390 women aged 35-42 years. INTERVENTION(S): A single injection of 150 μg of corifollitropin alfa or daily 300 IU of recombinant FSH for the first 7 days then daily recombinant FSH until three follicles reach ≥17 mm in size. Ganirelix was started on stimulation day 5 up to and including the day of recombinant hCG administration. If available, two good quality embryos were transferred on day 3. MAIN OUTCOME MEASURE(S): Vital pregnancy rate (PR), number of oocytes, and live birth rate. RESULT(S): Vital PRs per started cycle were 23.9% in the corifollitropin alfa group and 26.9% in the recombinant FSH group, with an estimated difference (95% confidence interval) of -3.0% (-7.4 to 1.4). The mean (SD) number of recovered oocytes per started cycle was 10.7 (7.2) and 10.3 (6.8) in the corifollitropin alfa and the recombinant FSH groups, respectively, with an estimated difference of 0.5 (-0.2 to 1.2). The live birth rates per started cycle were 21.3% in the corifollitropin alfa group and 23.4% in the recombinant FSH group, with an estimated difference (95% confidence interval) -2.3% (-6.5 to 1.9). The incidence of serious adverse events was 0.4% versus 2.7% in the corifollitropin alfa and recombinant FSH groups, respectively, and of ovarian hyperstimulation syndrome (OHSS; all grades) was 1.7% in both groups. CONCLUSION(S): Treatment with corifollitropin alfa was proven noninferior to daily recombinant FSH with respect to vital PRs, number of oocytes retrieved, and live birth rates, and was generally well tolerated. CLINICAL TRIAL REGISTRATION NUMBER: NCT01144416. SN - 1556-5653 UR - https://www.unboundmedicine.com/medline/citation/26003273/Large_comparative_randomized_double_blind_trial_confirming_noninferiority_of_pregnancy_rates_for_corifollitropin_alfa_compared_with_recombinant_follicle_stimulating_hormone_in_a_gonadotropin_releasing_hormone_antagonist_controlled_ovarian_stimulation_protocol_in_older_patients_undergoing_in_vitro_fertilization_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0015-0282(15)00291-5 DB - PRIME DP - Unbound Medicine ER -