Letrozole in Stimulated IVF Cycles
关键词
抽象
描述
Trial design:
Infertile women undergoing IVF treatment will be randomized into one of the following two groups by an online randomization program:
Letrozole group: letrozole 2.5mg daily will be given at the start of the antagonist during ovarian stimulation i.e. day 5 of stimulation.
Control group: standard care with FSH alone during ovarian stimulation.
Intervention:
Subjects can be put on oral contraceptive pill in the preceding cycle for scheduling stimulation. On day 2-3, a pelvic ultrasound will be performed for antral follicle count.
Letrozole group:
Daily 150-300 IU human menopausal gonadotrophin (HMG) / Follicle stimulating hormone (FSH) from cycle day 2-4 (at least 5 days after stopping the oral contraceptive pill) and co-treatment with letrozole 2.5 mg daily from stimulation day 5 until the day before hCG administration. GnRH antagonist (cetrotide or orgalutran) 0.25 mg daily from stimulation day 5 until the day of hCG administration.
Control group:
Daily 150-300 IU HMG/FSH cycle day 2-4 (at least 5 days after stopping the oral contraceptive pill) until the day before hCG administration. GnRH antagonist 0.25 mg daily from stimulation day 5 until the day of hCG administration.
- 150 IU HMG/FSH for women with AFC >15
- 225 IU HMG/FSH for those with AFC 5-15
- 300 IU HMG/FSH for those with AFC<5
A blood sample will be taken and analyzed in the local laboratory for serum E2, P and testosterone levels on cycle day 2 or 3 (baseline) and day of hCG (or the day before). The remaining serum will be frozen and stored for later analysis.
A sample of follicular fluid (FF) will be collected from the first blood free follicle. The FF will be frozen and stored for later analysis: Estradiol, testosterone, inhibin B and AMH levels.
All techniques of IVF including harvesting of oocytes, insemination with specially prepared sperm, embryo culture in the laboratory, embryo transfer and luteal phase support will be according to local protocols. One or two embryos or blastocysts will be replaced.
A pregnancy test will be carried out 2 weeks after embryo transfer in both arms. All women who have a positive pregnancy test 2 weeks after embryo transfer will undergo a transvaginal ultrasound scan to identify the presence and number of gestation sac with a fetal heart signifying an ongoing pregnancy. Pelvic scan will be repeated at 8 weeks, 12 weeks, 24 weeks and 36 weeks of gestation for fetal growth.
日期
| 最后验证: | 03/31/2019 |
| 首次提交: | 09/12/2016 |
| 提交的预估入学人数: | 09/19/2016 |
| 首次发布: | 09/22/2016 |
| 上次提交的更新: | 04/15/2019 |
| 最近更新发布: | 04/16/2019 |
| 实际学习开始日期: | 10/31/2016 |
| 预计主要完成日期: | 12/29/2019 |
| 预计完成日期: | 12/29/2020 |
状况或疾病
干预/治疗
Drug: Letrozole group
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Letrozole group Letrozole + standard treatment:
Daily 150-300 IU human menopausal gonadotrophin (HMG) / Follicle stimulating hormone (FSH) from cycle day 2-4 (at least 5 days after stopping the oral contraceptive pill) and co-treatment with letrozole 2.5 mg daily from stimulation day 5 until the day before hCG administration. GnRH antagonist (cetrotide or orgalutran) 0.25 mg daily from stimulation day 5 until the day of hCG administration. | Drug: Letrozole group Daily 150-300 IU human menopausal gonadotrophin (HMG) / Follicle stimulating hormone (FSH) from cycle day 2-4 (at least 5 days after stopping the oral contraceptive pill) and co-treatment with letrozole 2.5 mg daily from stimulation day 5 until the day before hCG administration. GnRH antagonist (cetrotide or orgalutran) 0.25 mg daily from stimulation day 5 until the day of hCG administration. |
| No Intervention: Control group Standard treatment:
Daily 150-300 IU HMG/FSH cycle day 2-4 (at least 5 days after stopping the oral contraceptive pill) until the day before hCG administration. GnRH antagonist 0.25 mg daily from stimulation day 5 until the day of hCG administration. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - women under 42 years of age - medical indication for IVF treatment - antral follicle count prior to ovarian stimulation >=3 - informed consent Exclusion Criteria: - women using donor oocytes - women undergoing preimplantation genetic diagnosis - women with abnormal uterine cavity shown on hysterosalpingogram or saline infusion sonogram - women with hydrosalpinges shown on scanning and not corrected - previous documented poor response (<=3 oocytes) to ovarian stimulation using at least FSH 225 IU daily |
结果
主要结果指标
1. Live birth rate [through study completion, an average of 1 year]
次要成果指标
1. Miscarriage rate [up to 20 weeks of gestation]
2. Clinical and ongoing pregnancy rates [up to 20 weeks]
3. Ovarian hyperstimulation rate [about 1 month]
4. Total IU of FSH used per cycle [about 2 weeks]
5. Number of follicles > 12 mm on day of hCG (or the day before) [about 2 weeks]
6. Number of oocytes obtained [On the operation day of transvaginal ultrasound guided oocyte retrieval]
7. Proportion of oocytes resulting in top quality day 2 (or day 3) embryos according to validated morphological criteria. [2-3 days after the transvaginal ultrasound guided oocyte retrieval operation]
8. Oocyte fertilization rate [2-3 days after the transvaginal ultrasound guided oocyte retrieval operation]
9. Number and quality of embryos obtained [2-3 days after the transvaginal ultrasound guided oocyte retrieval operation]
10. Endometrial thickness on day of hCG (or the day before) [on day of hCG (or the day before)]
11. Serum E2 level on day of hCG administration (or the day before) [on day of hCG administration (or the day before)]
12. Serum P levels on day of hCG administration (or the day before) [on day of hCG administration (or the day before)]
13. Serum testosterone levels on day of hCG administration (or the day before) [on day of hCG administration (or the day before)]
14. Follicular fluid E2 level [On the operation day of transvaginal ultrasound guided oocyte retrieval]
15. Follicular fluid testosterone level [On the operation day of transvaginal ultrasound guided oocyte retrieval]
16. Follicular fluid inhibin B level [On the operation day of transvaginal ultrasound guided oocyte retrieval]
17. Follicular fluid AMH level [On the operation day of transvaginal ultrasound guided oocyte retrieval]
18. Reported side effects [through study completion, an average of 1 year]
19. Complications of pregnancy [through study completion, an average of 1 year]
