Follicular Fluid, Serum Endocrine Profile Following Stimulation With Recombinant Gonadotropins or Highly Purified Human Menopausal Gonadotropin During GnRH-antagonist Protocol
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 主要终点
- Serum hormonal profile
研究概览
简要总结
In this study the investigators will try to discover whether there is a difference for any of the stimulation preparations - recombinant FSH + recombinant LH (pergoveris & luveris) vs. human menopausal gonadotropin (menopur) during GnRH-antagonist cycles in the meaning of androgenic hormones profile. The study question is whether using recombinant LH will result in different follicular hormonal milieu, serum endocrine profile or IVF outcomes than using highly purified urinary gonadotropins with hCG mimicking LH activity.
详细描述
ABSTRACT:
The optimal controlled ovarian stimulation (COH) protocol is yet to be decided and most probably there is no right protocol that is optimal for all patients.
The role of luteinizing hormone (LH) administration during controlled ovarian stimulation (COH) is widely debated in the current medical literature.
Until recently the only source for exogenous LH activity was HMG preparations, however, in the past few years an advancement in the field of recombinant technology resulted in recombinant preparations of LH. In contrast to LH activity in HMG which is mainly due to hCG rather than from LH, using r-LH provides true, consistent and precise LH activity.
In the past years few papers were published about the difference between recombinant follicle stimulating hormone (r-FSH) and menotropins but there is still a need for researching the different effects of gonadotropins preparations and in particular the effect of LH administration during COH in the manner of follicular endocrine characteristics, embryo quality and pregnancy outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Infertile women between 20-40 years of age
- •BMI 19-35
- •undergoing their 1-4 IVF cycle
排除标准
- •Suspected PCOS
- •History of OHSS
- •Patients who had a chronic illness or were receiving chronic medical treatment
研究组 & 干预措施
Recombinant preparations
干预措施: recombinant gonadotropins (Drug)
HP-HMG
Highly purified human menopausal gonadotropin
干预措施: HP-HMG (Drug)
结局指标
主要结局
Serum hormonal profile
时间窗: (1) day 1-3 of menstruation (Day-S); (2) day of or prior to hCG administration (Day-hCG); and (3) day of ovum pick-up (Day-OPU).
Hormonal profile = FSH, LH, progesterone, estradiol, testosterone, androstendione, 17-OH progesterone
Follicular fluid hormonal profile
时间窗: Ovum pick up day
Hormonal profile = FSH, LH, progesterone, estradiol, testosterone, androstendione, 17-OH progesterone
次要结局
- Number of top quality embryos(3 days after OPU)
- Clinical pregnancy(About three weeks after embryo transfer)
- Biochemical pregnancy(About two weeks after embryo tranfer)
- Ongoing pregnancy(10-12 weeks after embryo tranfer)
- Live birth rate(Until about 40 weeks after embryo transfer)
- Number of follicles(During stimulation - one-two dayes before ovum pick-up)
- Number of oocytes retrieved(1 day right after ovarian pick-up)
- Number of embryos(About 3 days after OPU (ovum pick-up))
- Implantation rate(About three weeks after embryo transfer)
研究者
Dr. Eran Zilberberg
Senior physician, Infertility & IVF Unit, Department of Obstetrics & Gynecology
Sheba Medical Center