Infertility
Conditions
Keywords
Poor ovarian response, in vitro fertilization, mild ovarian stimulation, controlled ovarian stimulation
Brief summary
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.
Detailed description
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.
Interventions
OTHERmild stimulation protocol
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.
OTHERcontrolled ovarian stimulation
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.
Sponsors
Huang Rui
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* a. Poor ovarian responders b. Normal BMI (18-25 Kg/m2) c. Regular menstruation (with cycle 23-35 days)
Exclusion criteria
* a. History of repeated IVF failure (previous IVF cycle \>2) b. Serious adenomyosis c. Polycystic ovary syndrome(PCOS) patients d. History of allergic to ovulation induction medicines e. Abnormal uterine cavity, i.e, intrauterine adhesion f. Attending other clinical trials in the same period. g. History of systemic disease contradictory to COH or pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical pregnancy rate | 7 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of oocytes retrieved | 3 weeks |
| Number of transferrable embryo | 3 weeks |
| normal fertilization rate | 3 weeks |
| implantation rate | 7 weeks |
| ongoing pregnancy rate | 3 months |
| Total dose of recombinant FSH consumption | 3 weeks |
| length of stimulation | 3 weeks |
| serum estradiol level | 3 weeks |
| serum LH level | 3 weeks |
| live birth rate | 10 months |
| serum FSH level | 3 weeks |
| FSH level in follicular fluid | 3 weeks |
| LH level in follicular fluid | 3 weeks |
| Estradiol level in the follicular fluid | 3 weeks |
| progesterone level in follicular fluid | 3 weeks |
| testerone level in the follicular fluid | 3 weeks |
| anti-müllerian hormone (AMH)level in follicular fluid | 3 weeks |
| Ovarian Hyperstimulation Syndrome (OHSS) rate | 7 weeks |
| serum progesterone level | 3 weeks |
Countries
China
Contacts
Primary ContactXing Yang, M.D.
Outcome results
None listed