Sexual Intercourse and Vaginal Absorption of Progesterone

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-13

Study Completion Date

2024-02-29

Brief Summary

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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.

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Detailed Description

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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

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Infertility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Estradiol / Progesterone

Intervention Type DRUG

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 event

Intervention Type BEHAVIORAL

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.

Interventions

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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).

Intervention Type DRUG

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* aged 18 to 40 inclusive

Exclusion Criteria

* 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

* Erectile or ejaculatory disorder

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes