infertility
Conditions
Interventions
Group A:Luveris 150 IU/day
ctrl:Luveris 75 IU/?
Sponsors
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. The subjects must be at least 18 years (including the 18th birthday) when they sign the informed consent and no more than 35 years (up to the day before 36th birthday) at the time of randomization. 2. Infertile women eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI). 3. AFC >= 5 (screening evaluations) or AMH >= 1.2ng/L(within 1 year before randomization). 4. The number of oocytes retrieved in the first stimulation cycle is 4-9 or withdrawn the stimulation due to poor respond (no more than 4 oocytes will be excepted), and subjects received no less than 150IU Gn per day at the beginning stimulation days and received more than 4000IU HCG for oocyte trigger. 5. The trial cycle will be the subjects secondary controlled ovarian stimulation cycle for IVF/ICSI. 6. Early follicular phase(cycle day 2-5) serum levels of FSH between 1 and 15IU/L. 7. At least one ovary must be accessible for oocyte retrieval. 8. Informed consent documents signed before randomization, and subjects willing to accept the protocol and follow-up. 9. Subjects willing to fresh embryo transfer. 10. Subjects willing to transfer 1-2 embryos. 11. Subjects willing to accept GONAL and Luveris for ovarian stimulation.
Exclusion criteria
Exclusion criteria: 1. Adenomyosis; 2. Known submucous fibroids; 3. Known polyps(polypectomy is allowed before the randomization); 4. Known congenital structural abnormalities; 5. Ovarian resistant syndrome, hypogonadotropic hypogonadism; 6. Any known clinically significant systemic disease; 7. Drug abusealcoholor sex transmitted disease; 8. BMI >= 30Kg/m2; 9. Known abnormal karyotype of the subject or her partner.PGT-SR; 10. PGT-M; 11. Known history of recurrent miscarriage(defined as three consecutive loss after ultrasound confirmation of pregnancy and before week 24 of pregnancy); 12. Failure to pregnancy more than three attempts of embryo transfer 13. Known inherited or acquired thrombophilia disease. 14. Known tumors of ovary, breast, uterus, adrenal gland, pituitary or hypothalamus. 15. The interval between the GnRha and Gn > 21 days. 16. One or more follicles > 10mm(including cysts) observed on the transvaginal ultrasound before randomization on stimulation day 1(puncture of cysts is allowed before randomization). 17. TESA/PESA is not allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical pregnancy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| total dose of Gn;total stimulation days of Gn;No. of oocyte;No. of good quality embryo;chemical pregnancy rate;implantation rate;ongoing pregnancy rate;live birth rate;cycle cancellation rate;abortion rate;number and distribution of oocyte retrieved; | — |
Countries
China
Contacts
Public ContactJia Huang
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Outcome results
None listed