Prospective Randomized Study for the Evaluation of Controlled Ovarian Stimulation With Corifollitropin Alpha in Patients With Expected or Poor Ovarian Response in IVF Cycles
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Rate of evolutionary gestation in each cycle
研究概览
简要总结
Patients who have had or are expected to have a poor ovarian response (POR), because they meet any of the criteria of Bologna, can benefit from ovarian stimulation with 150 mg of alpha Corifollitropin (CFA) (Elonva ®) as single dose for a week, in the cycles of in vitro fertilization (IVF).
In this study aims to demonstrate non-inferiority of the Corifollitropin Alpha (CFA ) versus daily administration of Human Menopausal Gonadotropin (hMG) (Menopur ®) during the first seven days of ovarian stimulation, in a protocol with gonadotropin-releasing hormone ( GnRH) antagonists
详细描述
One of the most significant problems in fertilization treatments is Controlled Ovarian Stimulation low responsiveness . The incidence of low ovarian response is estimated at around 10-25%.The wide range of prevalence reported in the literature can be explained by the lack of consensus existed as to the criteria for the low response.
The ovarian response to gonadotropin stimulation is crucial for successful assisted reproduction techniques .Cycles with low rates response was obtained and increased cancellation rate and worst pregnancy rates .
Different criteria for the definition of low response, different tests to assess ovarian reserve and different threshold values for each has been used.
In 2010 a group of experts from the ESHRE ,achieved consensus on the criteria for low ovarian response to homogenize the study groups and reach meaningful conclusions, are known as "The Bologna criteria" ,they defined the "Poor Ovarian Response" (POR).
There is not sufficient to recommend most of the proposed treatments to improve pregnancy rates in poor responders evidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •Signed informed consent to perform IVF and participation in this study.
- •Due to characteristics of our center not perform treatments in patients
- •40 years old ,and being one of the Bologna criteria that we will not be able to consider ,we decided to include patients affected subsidiary infertility treatment by IVF or intracytoplasmatic sperm injection (ICSI), present one of the following factors
- •Have a history of surgical or medical treatment as a risk factor for POR.
- •Patients witch had have a poor ovarian response in response to the ovarian controlled stimulation (previous cycle after conventional stimulation with ≤ 3 oocytes)
- •Patients with ovarian reserve test anti-mullerian hormone(AMH ) <1.1 ng / ml (<8 pM) or antral follicle count (AFC)<7
排除标准
- •Anovulation.
- •Patient with tubal factor, untreated
- •Patient with uterine pathology untreated
- •Couples with severe male factor, fresh count <5 million / ml, and azoospermia in which the patient's sperm, epididymal or testicular is used
研究组 & 干预措施
CFA , hMG,Ganirelix,choriogonadotropin alfa,progesterone.
Corifollitropin Alfa (CFA) 150 ug from the 2nd day of the cycle for 7 days. hMG 300 IU/24h, if required from the 8th day of the Controlled Ovarian Stimulation , until the day human chorionic gonadotropin ( hCG.) Ganirelix 0.25 mg,Dose: 250μg/24h since the day observe a follicle> 14mm. Recombinant choriogonadotropin alfa,Dose: 6,500 IU, pods, when follicles> 17 mm are observed.
Micronized natural progesterone. Route of administration: vaginal. Dose: 400mg/24, from embryo transfer until the day of b-hCG.
干预措施: Ganirelix 0.25 mg. (Drug)
CFA , hMG,Ganirelix,choriogonadotropin alfa,progesterone.
Corifollitropin Alfa (CFA) 150 ug from the 2nd day of the cycle for 7 days. hMG 300 IU/24h, if required from the 8th day of the Controlled Ovarian Stimulation , until the day human chorionic gonadotropin ( hCG.) Ganirelix 0.25 mg,Dose: 250μg/24h since the day observe a follicle> 14mm. Recombinant choriogonadotropin alfa,Dose: 6,500 IU, pods, when follicles> 17 mm are observed.
Micronized natural progesterone. Route of administration: vaginal. Dose: 400mg/24, from embryo transfer until the day of b-hCG.
干预措施: Recombinant choriogonadotropin alfa (Drug)
CFA , hMG,Ganirelix,choriogonadotropin alfa,progesterone.
Corifollitropin Alfa (CFA) 150 ug from the 2nd day of the cycle for 7 days. hMG 300 IU/24h, if required from the 8th day of the Controlled Ovarian Stimulation , until the day human chorionic gonadotropin ( hCG.) Ganirelix 0.25 mg,Dose: 250μg/24h since the day observe a follicle> 14mm. Recombinant choriogonadotropin alfa,Dose: 6,500 IU, pods, when follicles> 17 mm are observed.
Micronized natural progesterone. Route of administration: vaginal. Dose: 400mg/24, from embryo transfer until the day of b-hCG.
干预措施: Micronized natural progesterone. (Drug)
hMG ,Ganirelix,choriogonadotropin alfa,progesterone
Human Menopausal Gonadotropin (hMG). Dose: 300 IU/24h from the 2nd day of the cycle throughout the stimulation.
Ganirelix 0.25 mg,Dose: 250μg/24h since the day observe a follicle> 14mm. Recombinant choriogonadotropin alfa,Dose: 6,500 IU, pods, when follicles> 17 mm are observed.
Micronized natural progesterone. Route of administration: vaginal. Dose: 400mg/24, from embryo transfer until the day of b-hCG.
干预措施: Ganirelix 0.25 mg. (Drug)
hMG ,Ganirelix,choriogonadotropin alfa,progesterone
Human Menopausal Gonadotropin (hMG). Dose: 300 IU/24h from the 2nd day of the cycle throughout the stimulation.
Ganirelix 0.25 mg,Dose: 250μg/24h since the day observe a follicle> 14mm. Recombinant choriogonadotropin alfa,Dose: 6,500 IU, pods, when follicles> 17 mm are observed.
Micronized natural progesterone. Route of administration: vaginal. Dose: 400mg/24, from embryo transfer until the day of b-hCG.
干预措施: Recombinant choriogonadotropin alfa (Drug)
hMG ,Ganirelix,choriogonadotropin alfa,progesterone
Human Menopausal Gonadotropin (hMG). Dose: 300 IU/24h from the 2nd day of the cycle throughout the stimulation.
Ganirelix 0.25 mg,Dose: 250μg/24h since the day observe a follicle> 14mm. Recombinant choriogonadotropin alfa,Dose: 6,500 IU, pods, when follicles> 17 mm are observed.
Micronized natural progesterone. Route of administration: vaginal. Dose: 400mg/24, from embryo transfer until the day of b-hCG.
干预措施: Micronized natural progesterone. (Drug)
结局指标
主要结局
Rate of evolutionary gestation in each cycle
时间窗: 20 week of gestation
Evolutionary pregnancy has been defined as gestation of at least 1 fetus reaches 20 weeks of gestation diagnosed by normal ultrasound or confirmed by live birth
oocytes (MII) rate by patient
时间窗: participants will be followed for the duration of the cycle,an expected average of 8-16 days.
When follicular puncture occurs, we value the number of punctured follicles, total oocytes and MII oocytes
次要结局
- Number of Participants with Adverse Events(participants will be followed for the duration of the cycle,an expected average of 16 days.)