Sexual Intercourse and Vaginal Absorption of Progesterone (SexVAP)

February 29, 2024 updated by: University Hospital, Montpellier

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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?

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU de Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: 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).
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Ferring Pharmaceuticals
IBSA Institut Biochimique SA

Investigators

  • Study Director: Noémie RANISAVJLEVIC, MD, CHU de Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2022

Primary Completion (Actual)

February 5, 2024

Study Completion (Actual)

February 29, 2024

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

February 8, 2022

First Posted (Actual)

February 9, 2022

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL21_0182
  • 2021-A01552-39 (Other Identifier: n° ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on Estradiol / Progesterone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe