Modification of Endometrial Receptivity After Vaginal Seminal Plasma Application: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Endometrial transcriptome profile: mRNA array (fold change)
研究概览
简要总结
The aim of the project is to investigate the effect of seminal plasma on the endometrium and to evaluate changes in the endometrial receptivity after exposure to seminal plasma.
Implantation is still an important limiting factor for the improvement of pregnancy rate in the Assisted Reproductive Technology (ART). Usually, in fertility clinics, only the spermatozoa are used for the treatments while the rest of the seminal fluid is discarded. However, the importance of seminal fluid in fertility has gained interest in the last years but no conclusive that has been obtained yet.
Experimental group:
We decided to focus our attention on lesbian couples and single women undergoing ART procedures because they could benefice the most from this treatment since they usually do not have contact with seminal plasma. Moreover, to the best of our knowledge, they have more problems in achieving a pregnancy than heterosexual couples. Our observation is supported by a preliminary analysis of data from the Dansk fertilitetsselskab.
Design Randomized, double-blinded, placebo-controlled study
- Group 1 treated: 20 healthy lesbian or single women receiving assisted reproduction
- Group 2 control: 20 healthy lesbian or single women receiving assisted reproduction
Treatment
- One month before the IVF procedure: First seminal plasma/placebo application during ovulation period
- Same month of the IVF procedure: second seminal plasma/placebo application after ovum pick up
5 days after the first application an endometrial biopsy and one blood sample will be taken for analysis.
Analysis:
Endometrial transcriptome microarray analysis that will be verified through protein analysis.
Differences in the transcriptome between the two groups will be compared with data in literature for an optimal endometrial receptivity. Moreover, clinical pregnancy rate and pregnancy outcome will be compared.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy lesbian and single women receiving IVF assisted reproduction treatment at OUH Fertility Clinic
排除标准
- •Language problems to such an extent that subjects do not understand the scope of the study.
- •Abnormal high follicle-stimulating hormone
- •severe endometriosis,
- •severe polycystic ovarian syndrome
- •chronic diseases
结局指标
主要结局
Endometrial transcriptome profile: mRNA array (fold change)
时间窗: 24 months
mRNA array ( fold change). Endometrial mRNA expression will be compared between treated and control group mRNA expression expression will be compared between treated and control group mRNA expression profiles will be compared with literature data for an optimal endometrial receptivity.
Endometrial protein concentration of leukemia inhibitory factor (LIF)
时间窗: 24 months
LIF concentration measured by ELISA test. LIF concentration will be compared between treated and control group. LIF has been chosen for its importance in implantation.
次要结局
- clinical pregnancy rate(6 months)
- pregnancy rate(12 months)
- Endometrial proteins concentration(24 months)
研究者
Jens Fedder
Professor, MD, PhD
Odense University Hospital