Micro RNA Profile in the Ovarian Follicle Fluid of Transgender Men Treated With Testosterone and the Association With Fertility Potential
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Characterization of micro RNA profile in follicle fluid of transgender men treated with testosterone.
研究概览
简要总结
The effects of gender transitioning, particularly the effects of testosterone exposure in transgender men, on the oocyte and embryo development are largely unknown. Based on prior studies suggesting that the extracellular RNAs secreted by the ovarian follicle cells reflect the oocyte and embryo biological state, the investigators propose to use these extracellular RNAs to gain insights into the effects of testosterone exposure in transgender men on their oocyte and embryo without impacting the clinical IVF process.
详细描述
Background:
MicroRNAs are small RNA molecules that control gene expression in the cell. micro RNAs are also found in the body fluids in vesicles known as exosomes that interact with cellular membranes, release their contents, thus responsible for cell-to-cell contact.
The ovarian follicle fluid contains various substances, including micro RNAs, which are secreted by the various follicle cells and plays an important role in the development and maturation of the oocyte. Recent studies have found that micro RNAs found in the follicle fluid play an important role in the maturation of the oocyte, fertilization, embryo quality, and implantation.
Transgenderism is an umbrella term describing people whose gender identity and/or expression does not align with their sex assigned at birth. A transgender man is a man who was assigned female at birth. The medical interventions for transgender men include hormonal (testosterone) treatment that can negatively affect fertility, and fertility preservation is an option to overcome this potential damage. The fertility preservation options for transmen include oocyte and embryo cryopreservation. The American Society for Reproductive Medicine (ASRM) recommends that: 1. All transgender patients will be counseled regarding the fertility options prior to initiating the medical transition. 2. Transgenders have to preserve gametes (cryopreservation) before starting hormonal therapy. 3. Transgenders that are already using cross-sex hormone treatment have to stop hormone treatment for at least 3 months before fertility preservation. The aim of the current study is to compare the micro RNA profile of the follicle fluid of IVF patients exposed to high testosterone levels with IVF patients with normal testosterone levels and examine the possible association between testosterone exposure and fertility potential.
Specific aims:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •* Patients aged 18 and older.
排除标准
- •Patients under 18 years old.
- •Patients who did not respond to hormone therapy and the IVF cycle was discontinued.
结局指标
主要结局
Characterization of micro RNA profile in follicle fluid of transgender men treated with testosterone.
时间窗: 5 years
The follicle fluid of transgender men will be collected during egg retrieval, and micro RNA will be isolated from the follicle fluid samples using The Norgen and The ExoRNeasy methods (followed by qRT-PCR validation) and subjected to RNA sequencing analysis using NEBNext multiple small RNAseq library preparation kits. Total Testosterone levels (ng/ml) in the blood will be examined in all patients prior to the IVF treatment.
次要结局
- The association between micro RNA profile in follicle fluid of transgender men and the number of eggs.(5 years)
- The association between micro RNA profile in follicle fluid of transgender men and the embryo development level.(5 years)
- The association between micro RNA profile in follicle fluid of transgender men and the embryo quality.(5 years)
- The association between micro RNA profile in follicle fluid of transgender men and the maturation level of the eggs.(5 years)
研究者
michal roll
Research & Development Director
Tel-Aviv Sourasky Medical Center