In This Study, the Addition of rLH, Increasing the Dose of rFSH and the Control Groups Regarding the Results of IVF in These Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 主要终点
- Pregnancy Rate
研究概览
简要总结
The investigators aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. The investigators evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients.
详细描述
- Aim
-We aimed to evaluate patients who had In-vitro fertilization treatment and who had COH (controlled ovarian hyperstimulation) cycles applying long protocol with GnRH (gonadotropin-releasing hormone) analogue with suboptimal response to the rFSH. We evaluated and compared the addition of rLH, increasing the dose of rFSH and the control groups regarding the results of IVF in these patients. 2. Material and Methods -Between 01.01.2009-30.04.2011, 137 patients presented with infertility to the unit of Assisted Reproduction Techniques- of the Department of Obstetrics and Gynecology- Meram Medical Faculty- Selcuk University and were planned for ICSI-ET (intracytoplasmic sperm injection-embryo transfer) with normal ovarian function, who had long protocol of GnRH analogue and COH (controlled ovarian hyperstimulation) with rFSH were included in the study. 52 patients were considered responsive to stimulation and composed the normal control group (Group 1). On the 7th day of stimulation transvaginal ultrasonography was carried out. Patients who had at least 6 follicles about 6-10mm but had no follicle above 10mm and E2 (Oestradiol) level of <250 pg / ml were considered to have suboptimal response to stimulation and were divided into two groups. For Group 2 (n = 50), 75IU / L rLH was added to the treatment, for Group 3 (n = 35), 75IU / L of rFSH was added to the treatment. IVF results were compared between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 23 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 23-39
- •Body mass index between 18 and 30 kg/m2
- •Baseline FSH ≤12 IU/l, E2 ≤ 80 pg/ml
- •The presence of both ovaries and uterine cavity capable of sustaining a pregnancy
- •Who had regular menstrual cycles (21-35 days) Confirmed absence of pregnancy and sufficient number of antral follicles on the transvaginal US examination on the 3rd day of menstruation
- •Who were having their first or second IVF trial.
排除标准
- •Grade III-IV endometriosis
- •Clinically significant condition preventing them from undergoing gonadotrophin treatment
- •More than two previous assisted cycles
- •Who had a single ovary
- •Unexplained gynaecological bleeding
- •Polycystic ovary or an ovarian cyst of unknown aetiology
- •Previously diagnosed with a space occupying lesion like submucous myoma , polyps, septum, synechia in the uterine cavity
- •Have a chromosomal anomaly.
研究组 & 干预措施
fix dose r-FSH (Gonal-f)
The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1
干预措施: fix dose r-FSH (Gonal-f) (Drug)
r-LH supplementation to r-FSH
On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.
干预措施: r-LH supplementation (Drug)
r-FSH (Gonal-f)
Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.
干预措施: r-FSH (Gonal-f) (Drug)
结局指标
主要结局
Pregnancy Rate
时间窗: Up to 9 month
percentage of participants with a pregnancy (a b-HCG determination was obtained and considered positive if the value was greater than 10 mIU/ml)
次要结局
- Fertilization Rate(up to 9 month)
- Number of Mature Oocyte(up to 9 month)
- the Number of Oocytes Retrieved(up to 9 month)
- Implantation Rates(up to 9 months)
研究者
fatma yazıcı yılmaz
medical doctor
Sisli Hamidiye Etfal Training and Research Hospital