Sexual Intercourse and Vaginal Absorption of Progesterone : Cross-over Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progesterone dosage 1
研究概览
简要总结
The objective of this project is to compare the vaginal absorption of progesterone administered in the vaginal ovum by measuring progesteroneemia in 3 situations (or "sexual event"): abstinence, sex protected by condoms and unprotected sex.
详细描述
Progesterone plays a key role in embryo implantation and maintenance of pregnancy.
In the context of Assisted Reproduction (ART), support for the luteal phase is often necessary and readily provided by the administration of progesterone, mainly vaginal in Europe.
Optimal absorption is essential because low progesterone levels are associated with the chances of lowered pregnancies.
However, it has been shown that vaginal absorption can be reduced following unprotected sex.
Would the use of a condom prevent this alteration of vaginal absorption?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Couples, volunteers, on an AMP journey
- •Having sexual intercourse with a low risk of transmission of sexually transmitted infection
- •Free and informed consent to participate in the study
- •Inclusion criteria specific to women:
- •aged 18 to 40 inclusive
排除标准
- •Exclusion criteria specific to women:
- •Currently taking hormone therapy that may alter progesteroneemia
- •Pathology that can modify progesteroneemia
- •Body mass index greater than or equal to 32 kg / m2
- •Contraindication to the use of hormone replacement therapy
- •Known intolerance to vaginal progesterone
- •Pregnant woman (βHCG assay positive) or breastfeeding
- •Exclusion criteria specific to men:
- •Erectile or ejaculatory disorder
- •Exclusion criteria specific to couples:
- •Person with poor oral and/or written French comprehension
- •Person who for psychological, social, family or geographical reasons could not be followed regularly
- •Vulnerable person (Article L1121-6 of the Public Health Code)
- •Protected person or unable to give consent
- •Person involvment in another clinical research
- •Person not affiliated with a French social security scheme or beneficiary of such a scheme
研究组 & 干预措施
Estradiol / Progesterone treatment
Estradiol (Provames®, 3 mg morning and evening, or 6 mg per day) Vaginal progesterone (400 mg, Progestan®, evening and morning, ie 800 mg per day).
干预措施: Estradiol / Progesterone (Drug)
Estradiol / Progesterone treatment
Estradiol (Provames®, 3 mg morning and evening, or 6 mg per day) Vaginal progesterone (400 mg, Progestan®, evening and morning, ie 800 mg per day).
干预措施: Sexual event (Behavioral)
结局指标
主要结局
Progesterone dosage 1
时间窗: Change from Baseline progesterone (Day 2) at Day 3
Change from baseline plasma progesterone (day 2), 11 hours after administration of progesterone vaginal capsules (400 mg) and protected or unprotected intercourse within one hour of progesterone administration, at day 3
Progesterone dosage 2
时间窗: Change from Baseline progesterone (Day 2) at Day 7
Change from baseline plasma progesterone (day 2), 11 hours after administration of progesterone vaginal capsules (400 mg) and protected or unprotected intercourse within one hour of progesterone administration, at day 7
次要结局
未报告次要终点