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Completed

NCT Number: NCT05232344

Sexual Intercourse and Vaginal Absorption of Progesterone

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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Key information

Conditions

Infertility Behavior Coitus Genital Diseases Sexual Behavior Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Montpellier

Montpellier, 34295, France

About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Estradiol / Progesterone

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

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.

Primary outcomes

  1. Progesterone dosage 1

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

    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

  2. Progesterone dosage 2

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

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Ferring Pharmaceuticals
  • IBSA Institut Biochimique SA

Registry information

Official study title

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

Acronym: SexVAP

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 9, 2022
Registry last updated
Mar 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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