NCT05232344

Sexual Intercourse and Vaginal Absorption of Progesterone

Sexual Intercourse and Vaginal Absorption of Progesterone : Cross-over Prospective Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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?

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Estradiol / Progesterone	Treatment with estradiol (Provames®, 3 mg morning and evening, or 6 mg per day) will start on the 1st or 2nd day of her period. This treatment is continued until the end of the study (discontinuation treatment after the blood test taken on Day 7). After ten days of minimum estradiol treatment (and up to 7 days later to be working days), vaginal progesterone treatment will start in the evening on Day 0 (400 mg, Progestan®, evening and morning, ie 800 mg per day).
BEHAVIORAL	Sexual event	A sexual intercourse (protected or not protected by condoms) will take place in a pre-defined order for each participant within one hour of the administration of the progesterone ovum on the evening of Day 2 and Day 6.

Timeline

• Start date: 2022-04-13
• Primary completion: 2024-02-05
• Completion: 2024-02-29
• First posted: 2022-02-09
• Last updated: 2024-03-04

Locations

1 site across 1 country: France