Among aged patients with poor ovarian reservation(defined as age 35 to 42 years; antral follicle count（AFC）≤ 5 or anti-mullerian hormone（AMH）≤ 1.2 ng/ml), cumulative live birth rate(CLBR) and time to live birth(TTLB) of the first stimulation cycle were compared between a starting dose of 300IU or 150IU rFSH in controlled ovarian stimulation with gonadotropin-releasing hormone（GnRH）antagonist protocol. This study is a prospective randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
On menstrual cycle day 2 or day 3, 300IU rFSH Gonal-F® will be administrated daily till the day of trigger. The dosage of rFSH can be adjusted only if there is a risk of ovarian hyperstimulation syndrome（OHSS）.
On menstrual cycle day 2 or day 3, 150IU rFSH Gonal-F® will be administrated daily till the day of trigger. The dosage of rFSH can be adjusted only if there is a risk of OHSS or insufficient follicular growth.
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, China
RECRUITINGCumulative live birth rate
Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions。And cumulative live birth rate is calculated by dividing the number of women achieving live birth after transfers of all study-specific embryos (within 1 year after randomization) by the total number of women randomized to the specific group.
Time frame: 22 months
Time to live birth
Time to live birth is defined as the interval between the date of randomization and achieving live birth.
Time frame: 22 months
Cycle cancellation rate
Cycle cancellation is defined as cycle cancelled before obtaining at least one viable embryo for any reason. And cycle cancellation rate is calculated by dividing the number of women cancelled their cycle before obtaining at least one viable embryo for any reason by the total number of women randomized to the specific group.
Time frame: 1 month
Number of MII eggs
MII eggs is defined as eggs retrieved that reach the MII phase.
Time frame: 1 month
Cumulative Clinic pregnancy rate
Clinic pregnancy will be diagnosed with the detection of an intrauterine gestation sac. And cumulative clinic pregnancy rate is calculated by the number of women who achieves clinical pregnancy after transfers of all study-specific embryos (within 1 year after randomization) by the total number of women randomized to the specific group.
Time frame: 14 months
cumulative pregnancy loss rate
Pregnancy loss is defined as a complete spontaneous abortion or a nonviable pregnancy before 28 weeks of gestation. And cumulative pregnancy loss rate is calculated as the number of pregnancy losses / number of clinical pregnancy after transfers of all study-specific embryos (within 1 year after randomization).
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Time frame: 19 months
Implantation rate
Number of gestation sac detected / number of embryo transferred.
Time frame: 14 months
Multiple pregnancy rate
Number of multiple pregnancies / number of clinical pregnancies over (up to) 3 transfers within 1 year.
Time frame: 22 months
Neonatal malformation rate
Number of infant diagnosed as neonatal malformation / the total number of infant delivered after 28 weeks of gestation.
Time frame: 22 months
Good quality embryo rate
Good quality embryo is defined as embryo that is graded as 6CII or better or blastocyst. And good quality embryo rate is calculated by dividing the number of good quality embryo by the total number of embryo obtained after fertilization in the specific group.
Time frame: 1 month
Birth weight
Weight of newborns at delivery
Time frame: 22 months