Sexual Intercourse and Vaginal Absorption of Progesterone

Study Overview
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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.

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?

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

Conditions
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Infertility

Intervention / Treatment
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* Drug: Estradiol / Progesterone
* Behavioral: sexual event


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Estradiol / Progesterone treatment<br>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). | Drug: Estradiol / Progesterone<br>* 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).<br>Behavioral: sexual event<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Change from Baseline progesterone (Day 2) at Day 3 | 
| Progesterone dosage 2 | 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 | Change from Baseline progesterone (Day 2) at Day 7 |