Is Hormonal Exposure of Endometrium on the First Day After Menstruation Associated With the Probability of Pregnancy in Patients Treated With Rec-FSH/ GnRH Antagonist? A Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- Ongoing pregnancy rate.
研究概览
简要总结
The proposal of this study is to evaluate the association between the achievement of ongoing pregnancy and hormonal levels on the first day after the period had stopped in rec-FSH/GnRH- antagonist cycles.
详细描述
Ovarian stimulation will be achieved by rec- FSH, Puregon® starting on day 2 of the cycle at a dose of 200 IU/day. The dose of rec-FSH remains unchanged during stimulation until day 10 of the cycle. If it is necessary to increase the dose of rec-FSH after 10 days of stimulation, or to decrease the dose of rec-FSH due to a risk of OHSS, the patient will be dropped out of the study.
To inhibit premature LH surge daily GnRH - antagonist (orgalutran 0,25mg ) is used from the morning of day 6 of stimulation.
Final oocyte maturation will be achieved by administration of 10.000 IU of HCG (Pregnyl®) as soon as ≥ 3 follicles ≥ 17 mm are present. E2 levels should not be criteria for HCG administration. Oocyte retrieval will be carried out 36 hours after HCG administration. Conventional IVF or ICSI will be carried out. Embryo transfer will be carried out day3 or day5 after oocyte retrieval.
Similar luteal support for all patients with vaginal administration of 600mg natural micronised progesterone in three separate doses (Utrogestan® 200mg 3xday) starting one day after oocyte retrieval will be used. Hormonal assessment (E2,FSH,LH,Progesterone) will be performed at initiation of stimulation, on the first day after the period had stopped and every 2 days until the day of HCG administration.
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
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≤ 39 years
- •Body mass index between 18 and 29 kg/m²¬
- •Regular cycles between 25-34 days
- •Presence of both ovaries
- •Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle
- •Treatment with IVF/ICSI
- •Embryo transfer day 3 or day 5 (1 or 2 embryos)
- •Patients can enter in the study only once
排除标准
- •Presence of endometriosis stage ≥3(AFS)
- •Polycystic ovarian syndrome (Rotterdam criteria)
- •Need for preimplantation genetic diagnosis (PGD)
- •Azoospermia testicular sperm extraction (TESE)
结局指标
主要结局
Ongoing pregnancy rate.
时间窗: 3 months
次要结局
未报告次要终点