The Impact of Vaginal Intercourse on Pregnancy Rates After Frozen Embryo Transfer; A Single Blinded Randomized Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 主要终点
- Pregnancy rates
研究概览
简要总结
This study aims to evaluate whether allowing unprotected vaginal intercourse 24 hours after frozen embryo transfer will result in higher ongoing clinical pregnancy rates in comparison to having participants abstain from unprotected vaginal intercourse until pregnancy test (10-14 days after frozen embryo transfer).
详细描述
Given the overwhelming evidence suggesting beneficial effect of seminal plasma on embryo implantation, we sought to explore this benefits in in vitro fertilization treatments by limiting the study cohort to those having frozen embryo transfer with programmed hormone replacement for endometrial preparation and some form of parenteral progesterone supplementation. This design will enable us to overcome the concerns and limitations of all previous studies. In this study, patients will be randomized into two groups, group 1 will have their frozen embryo transfer followed by current standard of care (no unprotected vaginal intercourse until pregnancy test) and group 2 will have their frozen embryo transfer followed by unlimited unprotected vaginal intercourse starting 24 hours after transfer. The primary endpoint of the study will be ongoing clinical pregnancy
rates in the two groups while secondary endpoints will include implantation, positive pregnancy, miscarriage and live birth rates. Overall, this study aims to investigate whether the elimination of current universal pelvic rest protocol in patients undergoing frozen embryo transfer will help optimize pregnancy outcomes.
This study aims to evaluate whether allowing unprotected vaginal intercourse 24 hours after frozen embryo transfer will result in higher ongoing clinical pregnancy rates in comparison to having participants abstain from unprotected vaginal intercourse until pregnancy test (10-14 days after frozen embryo transfer).
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
After informed consent signing and randomization using a computer generated randomization scheme, the Research Nurse will open a numbered, opaque, and sealed envelope, within which there will be a white sheet of paper labelled with the patient assigned group. The participant will be informed of their assigned group by the Research Nurse. Patients assigned to the study group will be handed a log to record the number of times the patient engages in unprotected vaginal intercourse. The fertility providers will be blinded to the patients assigned treatment group. Patients who do not consent to be part of the study will still undergo their planned frozen embryo transfer per protocol.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •female fertility patients having frozen embryo transfer
- •programmed hormone replacement (Oral Estrace, Vivelle dot (patch), intravenous Estradiol) with and without gonadotrophin releasing hormone analogue pretreatment and some form of parenteral progesterone supplementation (daily or every 3 days intramuscular Progesterone) for luteal support
排除标准
- •unable to provide informed consent
- •not undergoing programmed hormone replacement for frozen embryo transfer (natural cycle frozen embryo transfer)
- •undergoing fresh embryo transfer
- •not able to engage in heterosexual intercourse (same sex couple, partner with severe sexual dysfunction)
- •cannot undergo unprotected vaginal intercourse (infected with hepatitis B, C, or human immunodeficiency virus).
研究组 & 干预措施
Intercourse Group
unlimited unprotected vaginal intercourse starting 24 hours after the frozen embryo transfer
干预措施: Vaginal unprotected intercourse (Behavioral)
Pelvic Rest Group
pelvic rest after frozen embryo transfer until positive pregnancy test
结局指标
主要结局
Pregnancy rates
时间窗: up to 2 years
A serum quantitative pregnancy test will be performed 10-14 days following the frozen embryo transfer per clinic protocol. Positive pregnancy test is defined a serum quantitative beta hCG \> 5 mU/mL.
次要结局
- Implantation rates(up to 2 years)
- Clinical pregnancy rate(up to 2 years)
- Biochemical pregnancy rate(up to 2 years)
- Miscarriage rate(up to 2 years)
- Live birth rate(up to 2 years)