Sexual Intercourse and Vaginal Absorption of Progesterone

University Hospital, Montpellier40 enrolled

Overview

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.

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?

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infertility

Interventions

Estradiol / ProgesteroneDRUG

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).

Sexual eventBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: 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

Locations (1)

CHU de Montpellier

Montpellier, France

Outcomes

Primary Outcomes

Progesterone dosage 1

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

Time frame: Change from Baseline progesterone (Day 2) at Day 3

Progesterone dosage 2

Time frame: Change from Baseline progesterone (Day 2) at Day 7

Data from ClinicalTrials.gov

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