A Prospective, Single Center, Observational Study on the Predictive Factors of Ovarian Response in Ovulation Induction (OI) With Intrauterine Insemination (IUI) of a Gonal-f Low-dose Step-up Regimen
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of follicles 11-15 mm and ≥ 16 mm in diameter, estradiol (E2) levels and endometrial thickness
研究概览
简要总结
This is a single center, prospective, observational study on the use of Gonal-f in controlled ovarian hyperstimulation (COH) in subjects undergoing ovulation induction/ intrauterine insemination (OI/IUI) therapy across Taiwan. It has been observed in the previous studies that COH with follicle stimulating hormone (FSH) is considered as one of the positive predictors of an ongoing pregnancy. Many studies in the past have tried to predict the FSH threshold, defined as the FSH dose on the day when a follicle is >10 mm in diameter, but no studies have been conducted to date to determine the predictive factors for a monofollicular development after COH in IUI cycles. Monofollicular growth contributes significantly to the reduction of multiple pregnancies and thus minimize the risks associated with such pregnancies. This study would provide preliminary data on the factors associated with a monofollicular development in Gonal-f treated cycles using a low dose step-up regimen.
详细描述
Ovarian stimulation improves the cycle fecundity rate in part by increasing the number of follicles available for fertilisation and correcting subtle, unpredictable ovulatory dysfunction. Intrauterine insemination is an established treatment for subfertility due to cervical factors, male factors, or unexplained etiology. Ovulation induction aims at the selection of a single follicle that would be able to reach the pre-ovulatory size and rupture. The ovarian sensitivity to FSH (FSH threshold) has to be identified to avoid multiple follicular development and hence, the lowest effective dose of FSH should be used in treating infertility.
Treatment in subjects is individualised and is monitored by serum estradiol (E2) measurements and ultrasound scans of the ovaries to assess the endometrial thickness. It has been observed in earlier studies that in OI for unexplained non-conception, induction of more than one follicle did not improve the ongoing pregnancy rate but increased the risk of multiple pregnancies. Therefore, to reduce the number of multiple pregnancies, in all IUI cycles for unexplained non-conception, monofollicular growth was suggested.
The 'low-dose step-up' protocol is the most suitable method to establish an appropriate FSH threshold, which involves a starting FSH dose of 75 IU/day given for 7 to 14 days. Subsequent dose increments of 37.5 IU/day at weekly intervals is determined based on the ovarian response, usually when a follicle of diameter ≥10 mm is not seen in the ovaries. Human chorionic gonadotrophin (hCG) is then injected when the leading follicle is ≥18 mm in diameter.
OBJECTIVES
Primary objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects aged between 20 and 35 years
- •Subjects with regular menstrual cycle of 25 - 35 days
- •Subjects with both ovaries
- •Subjects with normal uterine cavity as investigated by either ultrasound scan or hysteroscopy and patent fallopian tube
- •Subjects with baseline serum FSH level within normal range of the clinic
- •Subjects whose male partner's semen is considered adequate for IUI in accordance to the centre's standard practice
排除标准
- •Subjects with any contraindication to being pregnant and/or carrying a pregnancy to term
- •Subjects with extrauterine pregnancy or abortion in the past 3 months
- •Subjects with abnormal gynaecological bleeding of undetermined origin
- •Subjects with history of OHSS
- •Subjects with known hypersensitivity to recombinant FSH preparations or any of their recipients
结局指标
主要结局
Number of follicles 11-15 mm and ≥ 16 mm in diameter, estradiol (E2) levels and endometrial thickness
时间窗: On the day of hCG administration (during 24-48 hrs after the last Gonal-f injection)
Outcomes of the treatment (Pregnancy status)
时间窗: Stimulation start to pregnancy assessment
Clinical pregnancy, multiple pregnancy, miscarriage, cycle cancellation, Ovarian hyperstimulation syndrome (OHSS) and severity.
Total dose of Gonal-f used during stimulation, threshold of Gonal-f dose (daily dose of Gonal-f when follicular growth is > 11 mm in diameter)and duration of Gonal-f treatment
时间窗: During the period of ovarian stimulation
次要结局
- Proportion of subjects with monofollicular development(On the day of hCG administration (during 24-48 hrs after the last Gonal-f injection))