This is a prospective, randomized clinical trial to compare the efficiency and safety of mild stimulation and controlled ovarian stimulation protocol on the treatment of POR. The randomization is achieved on the basis of a computer-generated randomization list in a 1:1 ratio.
500 poor ovarian responders will be equally randomized to two different ovarian stimulation protocol arms,i.e, mild ovarian stimulation(experimental arm) or controlled ovarian stimulation(control arm). In experimental arm, patients will received letrozole 5mg per day from cycle day 3 to 7 and recombinant follicle-stimulating hormone (FSH) 150 international unit (IU) on day 4 and 6. The dose of recombinant FSH is adjusted according to the ovarian response and the gonadotropin-releasing hormone(GnRH)antagonist(Cetrotide) 0.25mg per day is administrated when the estradiol level reaches 200 pg/ml and the serum luteinizing hormone (LH)level rises above 2 times of basal LH level. In control arm,patients will be stimulated with short-acting GnRH agonist long protocol. After complete downregulation is achieved through GnRH-agonist, recombinant FSH 300 IU/d is given for 5 days, then the dose of recombinant FSH is adjusted according to ovarian response. The clinical and ongoing pregnancy rate and other secondary outcome parameters are compared between these two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
letrozole is used from cycle day 3 to 7 and low dose recombinant FSH(no more than 150 IU/d) is used on cycle day 4,6 and 8 onwards. GnRH antagonist is only applied in case of premature LH rise might happen.
After fully downregulation by using short-acting GnRH agonist, 300 IU/d recombinant FSH is administrated for 5 days, then the dose is adjusted according to ovarian response.
sixth affiliated hospital of Sun Yet-san University
Guangzhou, Guangdong, China
clinical pregnancy rate
Time frame: 7 weeks
live birth rate
Time frame: 10 months
Number of oocytes retrieved
Time frame: 3 weeks
Number of transferrable embryo
Time frame: 3 weeks
normal fertilization rate
Time frame: 3 weeks
implantation rate
Time frame: 7 weeks
ongoing pregnancy rate
Time frame: 3 months
Total dose of recombinant FSH consumption
Time frame: 3 weeks
length of stimulation
Time frame: 3 weeks
serum estradiol level
Time frame: 3 weeks
serum LH level
Time frame: 3 weeks
serum progesterone level
Time frame: 3 weeks
serum FSH level
Time frame: 3 weeks
FSH level in follicular fluid
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Time frame: 3 weeks
LH level in follicular fluid
Time frame: 3 weeks
Estradiol level in the follicular fluid
Time frame: 3 weeks
progesterone level in follicular fluid
Time frame: 3 weeks
testerone level in the follicular fluid
Time frame: 3 weeks
anti-müllerian hormone (AMH)level in follicular fluid
Time frame: 3 weeks
Ovarian Hyperstimulation Syndrome (OHSS) rate
Time frame: 7 weeks