Prospective, Randomized Open Trial to Evaluate the Efficacy of Highly Purified Urinary FSH Versus Recombinant FSH in Oocyte Donors Undergoing Controlled Ovarian Stimulation Based on Receptor N680S FSH Gene Polymorphism. Genodon Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- number of cumulus-oocyte complexes obtained
研究概览
简要总结
Exploratory, prospective, randomized, comparative, open trial with control group treated to assess whether the effective use of urinary FSH (uFSH) or recombinant FSH (rFSH) can be influenced by genotype of receptor N680S FSH Gene Polymorphism.
详细描述
The aim of this study is to determine whether the number of oocytes obtained in women oocyte donors may be different with the use of rFSH or uFSH based on receptor N680S FSHR gene polymorphism.
This is an exploratory, prospective, randomized, comparative, open trial with control group treated according to the usual therapeutic approach in our institution for ovarian stimulation for oocyte donors prospective exploratory study control group .
Three groups will be set based on follicle-stimulating hormone receptor (FSHR) genotype for the polymorphism N680: Group SS (Ser/Ser), group SN (Ser/Asn) and group NN (Asn/Asn). Donor members of each group will be randomly assigned to receive daily 225 IU of recombinant or urinary FSH for controlled ovarian stimulation protocol with antagonists. To avoid unintentional bias, allocation to treatment group will take place at the time in which ovarian stimulation according begins with a list of random allocation of treatments for each of the groups (SS , SN and NN) that will be associated the code of the patient and are prepared and will be available before the start of the study. The code assignment and treatment of the patient will consecutively in the order of the list and must be recorded in the medical history of the patient. The next scheduled patient will be assigned to the code and the next immediate treatment in this list.
The protocol for controlled ovarian stimulation in oocyte donors, will be performed always according to the usual protocol in the Instituto Bernabeu.
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 30 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Be considered eligible to get into the oocyte donation program of Instituto Bernabeu
- •Age between 18 and 30 years
- •Body Mass Index over 18 and under 28
- •Antral follicle count greater than 9 and less than 25 (adding both ovaries)
- •Patients starting ovarian stimulation with 225 IU of FSH
- •Presence of both ovaries
- •Ability to participate and comply with the study protocol
- •Signing the written consent form
- •Not having received treatment with ovulation stimulators in the 3 months prior to stimulation
排除标准
- •Not suitable for inclusion in the oocyte donation program of Institute Bernabeu
- •Concurrent participation in another study
研究组 & 干预措施
Urinary follicle-stimulating hormone
Controled Ovarian stimulation with urinary follicle-stimulating hormone
干预措施: Urinary follicle-stimulating hormone (Drug)
Recombinant follicle-stimulating hormone
Ovarian stimulation with recombinant follicle-stimulating hormone
干预措施: Recombinant follicle-stimulating hormone (Drug)
结局指标
主要结局
number of cumulus-oocyte complexes obtained
时间窗: through study completion, an average of 2 weeks
number of cumulus-oocyte complexes obtained by follicle puncture at the end of ovarian stimulation
次要结局
- duration of stimulation (days)(through study completion, an average of 2 weeks)
- FSH treatment units obtained by oocyte(through study completion, an average of 2 weeks)
- FSH treatment cost per oocyte obtained(through study completion, an average of 2 weeks)
- occurrence of side effects(through study completion, an average of 2 weeks)
- number of useful oocytes (inseminated or microinjected)(through study completion, an average of 2 weeks)
- fertilization rate(through study completion, an average of 2 weeks)
- number of metaphase II (MII) oocytes(through study completion, an average of 2 weeks)
研究者
Joaquín Llácer
Gynaecologist. Reproductive Medicine Specialist at Institute Bernabeu
Instituto Bernabeu