Sexual Intercourse and Vaginal Absorption of Progesterone (SexVAP)

University Hospital Center (CHU)

Status: Completed

Conditions: Infertility

Treatments: Behavioral: Sexual event; Drug: Estradiol / Progesterone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05232344

RECHMPL21_0182

2021-A01552-39 (Other Identifier)

Details and patient eligibility

About

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.

Full 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?

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Estradiol / Progesterone treatment

Experimental group

Description:

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).

Treatment:

Behavioral: Sexual event

Drug: Estradiol / Progesterone