John J Zhang1, Zaher Merhi2, Mingxue Yang3, Daniel Bodri3, Alejandro Chavez-Badiola3, Sjoerd Repping4, Madelon van Wely4. 1. Department of Reproductive Endocrinology and Infertility, New Hope Fertility Center, New York, NY. Electronic address: johnzhang98@yahoo.com. 2. Department of Obstetrics and Gynecology, Division of Reproductive Biology, New York University School of Medicine, New York, NY. 3. Department of Reproductive Endocrinology and Infertility, New Hope Fertility Center, New York, NY. 4. Center for Reproductive Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
Abstract
BACKGROUND: Minimal stimulation in vitro fertilization (mini-in vitro fertilization) is an alternative in vitro fertilization treatment protocol that may reduce ovarian hyperstimulation syndrome, multiple pregnancy rates, and cost while retaining high live birth rates. OBJECTIVE: We performed a randomized noninferiority controlled trial with a prespecified border of 10% that compared 1 cycle of mini-in vitro fertilization with single embryo transfer with 1 cycle of conventional in vitro fertilization with double embryo transfer. STUDY DESIGN:Five hundred sixty-four infertile women (<39 years old) who were undergoing their first in vitro fertilization cycle were allocated randomly to either mini-in vitro fertilization or conventional in vitro fertilization. The primary outcome was cumulative live birth rate per woman over a 6-month period. Secondary outcomes included ovarian hyperstimulation syndrome, multiple pregnancy rates, and gonadotropin use. The primary outcome was cumulative live birth per randomized woman within a time horizon of 6 months. RESULTS:Five hundred sixty-four couples were assigned randomly between February 2009 and August 2013 with 285 couples allocated tomini-in vitro fertilization and 279 couples allocated to conventional in vitro fertilization. The cumulative live birth rate was 49% (140/285) for mini-in vitro fertilization and 63% (176/279) for conventional in vitro fertilization (relative risk, 0.76; 95% confidence interval, 0.64-0.89). There were no cases of ovarian hyperstimulation syndrome after mini-in vitro fertilization compared with 16 moderate/severe ovarian hyperstimulation syndrome cases (5.7%) after conventional in vitro fertilization. The multiple pregnancy rates were 6.4% in mini-in vitro fertilization compared with 32% in conventional in vitro fertilization (relative risk, 0.25; 95% confidence interval, 0.14-0.46). Gonadotropin consumption was significantly lower with mini-in vitro fertilization compared with conventional in vitro fertilization (459 ± 131 vs 2079 ± 389 IU; P < .0001). CONCLUSION: Compared with conventional in vitro fertilization with double embryo transfer, mini-in vitro fertilization with single embryo transfer lowers live birth rates, completely eliminates ovarian hyperstimulation syndrome, reduces multiple pregnancy rates, and reduces gonadotropin consumption.
RCT Entities:
BACKGROUND: Minimal stimulation in vitro fertilization (mini-in vitro fertilization) is an alternative in vitro fertilization treatment protocol that may reduce ovarian hyperstimulation syndrome, multiple pregnancy rates, and cost while retaining high live birth rates. OBJECTIVE: We performed a randomized noninferiority controlled trial with a prespecified border of 10% that compared 1 cycle of mini-in vitro fertilization with single embryo transfer with 1 cycle of conventional in vitro fertilization with double embryo transfer. STUDY DESIGN: Five hundred sixty-four infertile women (<39 years old) who were undergoing their first in vitro fertilization cycle were allocated randomly to either mini-in vitro fertilization or conventional in vitro fertilization. The primary outcome was cumulative live birth rate per woman over a 6-month period. Secondary outcomes included ovarian hyperstimulation syndrome, multiple pregnancy rates, and gonadotropin use. The primary outcome was cumulative live birth per randomized woman within a time horizon of 6 months. RESULTS: Five hundred sixty-four couples were assigned randomly between February 2009 and August 2013 with 285 couples allocated to mini-in vitro fertilization and 279 couples allocated to conventional in vitro fertilization. The cumulative live birth rate was 49% (140/285) for mini-in vitro fertilization and 63% (176/279) for conventional in vitro fertilization (relative risk, 0.76; 95% confidence interval, 0.64-0.89). There were no cases of ovarian hyperstimulation syndrome after mini-in vitro fertilization compared with 16 moderate/severe ovarian hyperstimulation syndrome cases (5.7%) after conventional in vitro fertilization. The multiple pregnancy rates were 6.4% in mini-in vitro fertilization compared with 32% in conventional in vitro fertilization (relative risk, 0.25; 95% confidence interval, 0.14-0.46). Gonadotropin consumption was significantly lower with mini-in vitro fertilization compared with conventional in vitro fertilization (459 ± 131 vs 2079 ± 389 IU; P < .0001). CONCLUSION: Compared with conventional in vitro fertilization with double embryo transfer, mini-in vitro fertilization with single embryo transfer lowers live birth rates, completely eliminates ovarian hyperstimulation syndrome, reduces multiple pregnancy rates, and reduces gonadotropin consumption.