Early Follicular Phase vs Lutheal Phase Ovarian Stimulation in Bologna Criteria IVF/ICSI Cycles: A Randomized Comparative Single Center Trial. LUTEAL Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- number of oocytes in metaphase II obtained
研究概览
简要总结
Exploratory, prospective, randomized, comparative, open trial with control group treated to assess the efficacy of follicular phase ovarian stimulation compared to lutheal phase ovarian stimulation in women with Bologna criteria for poor ovarian response.
详细描述
Two arms is established, the study group that will start ovarian stimulation in the luteal phase and the control group that will start ovarian stimulation in the follicular phase.
The randomization will be made in the 2-3 day of the menstrual cycle, according to a list of random allocation of treatments. After check that there is no contraindication to start the stimulation, the patients will be assigned to the treatment group.
The patients in the control group (follicular phase group) will start stimulation with two vials of 150 IU recombinant FSH + 75 IU recombinant LH (Pergoveris® 150/75). The patients in the study group (luteal phase group) will perform daily urine LH test from day 7th of the cycle and will start the administration of 150 IU recombinant FSH + 75 IU recombinant LH (Pergoveris® 150/75) at two vials daily from the 4th day of the LH positive test.
Antagonist cetrorelix acetate (Cetrotide® ) administration will start when the largest follicle shall be equal or greater than 14 mm. From this moment controls every 24-72 hours with foliculometría by ultrasound and blood hormone analysis with determination of estradiol and progesterone. For the final oocyte maturation 2 vials daily of 0.2 mg triptorelin acetate (Decapeptyl®) is administered. Oocyte collection will be made by transvaginal ultrasound-guided puncture according to IB protocol
The dosages and protocols used will be the usual for patients with diagnostic of poor ovarian response.
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
- 是
入选标准
- •Patient Bologna meets the criteria to be diagnosed as low responder
- •Age under 41 years
- •Regular menstrual cycles between 21 and 35 days
- •Indication of in vitro fertilization
- •Indication of start stimulation with 300 IU of FSH
- •Presence of both ovaries
- •Ability to participate and comply with the study protocol
- •Having signed the written consent form
排除标准
- •Presence of follicles larger than 10 mm in the randomization visit
- •Endometriosis III / IV
- •Concomitant uterine pathology: adenomyosis, submucosal myomas, Asherman's syndrome...
- •Concurrent participation in another study
研究组 & 干预措施
Follicular phase
Controlled ovarian stimulation starts during follicular phase on day 2-3 of the menstrual cycle
干预措施: Follicular phase (Procedure)
Luteal phase
Controlled ovarian stimulation starts during luteal phase on day 3 to 5 after first LH positive urine test
干预措施: Luteal phase (Procedure)
结局指标
主要结局
number of oocytes in metaphase II obtained
时间窗: Through study completion, average 2 weeks
number of oocytes in metaphase II obtained by follicular puncture
次要结局
- duration of stimulation (days)(Through study completion, average 2 weeks)
- number of oocytes cumulus complexes(Through study completion, average 2 weeks)
- cycle cancellation rate(Through study completion, average 2 weeks)
- Luteinizing hormone levels following administration of agonist for final oocyte maturation(Through study completion, average 2 weeks)
- occurrence of side effects(Through study completion, average 2 weeks)
- fertilization rate(Through study completion, average 2 weeks)
研究者
Joaquín Llácer
Gynaecologist. Reproductive Medicine Specialist at Instituto Bernabeu
Instituto Bernabeu