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Sexual Intercourse and Vaginal Absorption of Progesterone (SexVAP)

Primary Purpose

Infertility

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Estradiol / Progesterone

sexual event

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

CHU de MontpellierRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Estradiol / Progesterone treatment

Arm 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).

Outcomes

Primary Outcome Measures

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

Progesterone dosage 2

Secondary Outcome Measures

Full Information

NCT ID

NCT05232344

First Posted

January 14, 2022

Last Updated

April 27, 2023

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT05232344

Brief Title

Sexual Intercourse and Vaginal Absorption of Progesterone

Acronym

SexVAP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 13, 2022 (Actual)

Primary Completion Date

October 12, 2023 (Anticipated)

Study Completion Date

December 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Estradiol / Progesterone treatment

Arm Type

Experimental

Arm 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).

Intervention Type

Drug

Intervention Name(s)

Estradiol / Progesterone

Intervention Description

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

Behavioral

Intervention Name(s)

sexual event

Intervention Description

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 Outcome Measure Information:

Title

Progesterone dosage 1

Description

Time Frame

Change from Baseline progesterone (Day 2) at Day 3

Title

Progesterone dosage 2

Description

Time Frame

Change from Baseline progesterone (Day 2) at Day 7

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Noémie RANISAVJLEVIC, MD

Phone

+334 67 33 64 81

n-ranisavljevic@chu-montpellier.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Nelly GUIGUE, CRA

n-guigue@chu-montpellier.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Noémie RANISAVJLEVIC, MD

Organizational Affiliation

CHU de Montpellier

Official's Role

Study Director

Facility Information:

Facility Name

CHU de Montpellier

City

Montpellier

ZIP/Postal Code

34295

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Noémie RANISAVLJEVIC, MD

Phone

+334 67 33 64 81

n-ranisavljevic@chu-montpellier.fr

First Name & Middle Initial & Last Name & Degree

Tal ANAHORY, MD

First Name & Middle Initial & Last Name & Degree

Noémie RANISAVLJEVIC, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Sexual Intercourse and Vaginal Absorption of Progesterone

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