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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mild ovarian stimulation | Experimental | Patients are stimulated with mild ovarian stimulation protocol,i.ed, from cycle day 3 to 7, letrozole 5mg per day are administrated and recombinant FSH 150 IU are given on day 4 and 6 . On cycle day 8, serum FSH LH, and estradiol levels are measured, and after then, the dose of recombinant FSH is adjusted according to the ovarian response and the maxim recombinant FSH dose is 150 IU/d. The GnRH-antagonist (Cetrotide) 0.25mg per day is administrated when the estradiol level reaches 200 pg/ml and the serum LH level rises above 2 times of basal LH level. |
|
| controlled ovarian stimulation | Active Comparator | Patients are stimulated using controlled ovarian stimulation protocol,i.e., from cycle day 18-22 (day 7 after ovulation) of previous cycle, all participants are given short-acting GnRH agonist (Triptorelin 0.05mg/d) for 14 days, then after checking serum FSH, LH and estradiol to make sure that complete downregulation is achieved, exogenous gonadotropin (recombinant FSH) 300 IU/d is given for 5 days, then the dose of recombinant FSH is adjusted according to ovarian response. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mild stimulation protocol | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| clinical pregnancy rate | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| live birth rate | 10 months | |
| Number of oocytes retrieved | 3 weeks | |
| Number of transferrable embryo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xing Yang, M.D. | Contact | yxing8358@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rui Huang, M.D. | sixth affiliated hospital of Sun Yet-san University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| sixth affiliated hospital of Sun Yet-san University | Guangzhou | Guangdong | 510010 | China |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| C092464 | LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)- |
| D007987 | Gonadotropin-Releasing Hormone |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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|
| controlled ovarian stimulation | Other | 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. |
|
|
| 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 |
| serum progesterone level | 3 weeks |
| 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 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |