Dienogest Versus Gonadotropin Releasing Hormone Agonist Pre-treatment in Women With Endometriosis Undergoing in Vitro Fertilization
试验速览
- 阶段
- 不适用
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Ongoing pregnancy rate
研究概览
简要总结
Endometriosis is a chronic gynecologic disease that affects approximately 10% of women in the reproductive age group . It is characterized by the presence of endometrial tissue outside the uterus, causing pelvic pain and subfertility. It is estimated that around 40% of infertile women have the diagnosis of endometriosis . Infertility secondary to endometriosis is thought to be multifactorial. Women with endometriosis often require in vitro fertilization (IVF). One medical intervention that has been shown to improve IVF outcomes in women with endometriosis is hormonal suppression with gonadotropic releasing hormone agonist (GnRH-a) for a period of 3 to 6 months .
In recent years, the effectiveness of dienogest, a fourth-generation progestin, for endometriosis treatment has been demonstrated. Dienogest seems to be as effective as GnRH-a in improving endometriosis-related pelvic pain [4]. However, no study has yet assessed whether dienogest has any benefit in treating endometriosis associated infertility.
The aim of our study is to evaluate the efficacy of dienogest versus GnRH-a in improving ongoing pregnancy rates in women undergoing IVF due to endometriosis. We will conduct a non-blinded randomized controlled trial. One group will receive dienogest 2mg daily for a period of 3 months followed by a standard IVF/Intracytoplasmic Sperm Injection (ICSI) cycle. The second group will receive one injection of 3.75mg of GnRH-a every 28 days for three doses followed by a standard IVF/ICSI cycle 3 months later. The third group will not receive any medical interventions before the planned IVF/ICSI cycle. We hypothesize that patients receiving dienogest will have similar ongoing pregnancy rates compared to patients receiving the GnRH-a injection. Secondary outcomes including number of gonadotropins consumed, number of stimulation days, number of metaphase II eggs retrieved, fertilization rate, embryo quality, miscarriage rate, clinical pregnancy rates, live birth rates and potential maternal and obstetrical complications will also be evaluated. We will also compare ongoing pregnancy rates between the groups receiving Dienogest and placebo, and GnRH agonist and placebo.
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary or secondary infertility
- •Endometriosis, stage III - IV, confirmed surgically by laparoscopy or laparotomy and/or radiologically by the presence of endometrioma on pelvic ultrasound or magnetic resonance imaging (MRI)
- •Normal uterine cavity assessed by hysteroscopy or hysterosalpingogram
- •Normal hormonal profile: TSH, prolactin, fasting blood sugar
- •Normal semen analysis and mild/moderate male factor (Total motile sperm count > 5 million/ml and/or normal WHO morphology >20%)
- •First IVF cycle or history of failed IVF cycles
- •Washout period of ≥6 months after any diagnostic or therapeutic surgery for endometriosis or after any medical treatment with Dienogest or GnRH agonist.
排除标准
- •• Low ovarian reserve defined by one of the following: low AMH ≤1.5ng/mL and/or basal day 3 FSH ≥ 10mIU/mL and/or basal day 3 Estradiol ≥ 60ng/mL and/or previous egg collection yield of ≤3 oocytes.
- •Absolute contraindications to dienogest, including:
- •undiagnosed abnormal vaginal bleeding
- •pregnancy and/or lactation
- •active venous thromboembolic disorder
- •history of or current arterial and cardiovascular disease (eg, MI, CVA)
- •diabetes mellitus with vascular involvement
- •history of or current severe hepatic disease where liver function tests remain abnormal
- •history of or current hepatic neoplasia (benign or malignant)
- •known or suspected sex-hormone-dependent malignancy
- •ocular lesions due to ophthalmic vascular disease, such as partial or complete vision loss or defect in visual fields
- •current or history of migraine with focal aura
- •hypersensitivity or poor tolerance to dienogest
研究组 & 干预措施
Dienogest
patients will receive daily dienogest (2mg) for a total of 3 months (84 days)
干预措施: Dienogest 2 MG (Drug)
Dienogest
patients will receive daily dienogest (2mg) for a total of 3 months (84 days)
干预措施: IVF/IVF+ART (Procedure)
GnRH agonist
patients will receive a single GnRH-a injection (3.25mg) every 28 days for three months.
干预措施: gonapeptyl (Drug)
GnRH agonist
patients will receive a single GnRH-a injection (3.25mg) every 28 days for three months.
干预措施: IVF/IVF+ART (Procedure)
Control Group
patients will not receive any medical intervention and will proceed with their IFV/ICSI cycles.
干预措施: IVF/IVF+ART (Procedure)
结局指标
主要结局
Ongoing pregnancy rate
时间窗: 12 weeks of gestation
pregnancy positive fetal cardiac activity with beyond 12 weeks of gestation (%)
次要结局
- Gonadotropin consumption (IU)(3 months)
- stimulation (days)(up to 15 days)
- metaphase II oocytes retrieved(12 weeks of gestation)
- Fertilization rate(day 2)
- Embryo quality.(day 3 or 5)
- Clinical pregnancy rate(12 weeks of gestation)
- Ongoing pregnancy rate -2(12 weeks of gestation)
研究者
Dina Chamsy
Assistant Professor,Minimally Invasive Gynecologic Surgery
American University of Beirut Medical Center