SexVAP: Sexual Intercourse and Vaginal Absorption of Progesterone

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Recruiting

CT.gov ID

NCT05232344

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Estradiol / Progesterone Behavioral: sexual event	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

33 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 13, 2022

Anticipated Primary Completion Date :

Apr 13, 2026

Anticipated Study Completion Date :

Apr 13, 2028

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Progesterone dosage 1 [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
Progesterone dosage 2 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Montpellier	Montpellier		France	34295

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

Study Director: Noémie RANISAVJLEVIC, MD, CHU de Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT05232344

Other Study ID Numbers:

RECHMPL21_0182

First Posted:

Feb 9, 2022

Last Update Posted:

Apr 18, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Estradiol

Progesterone

Study Results

No Results Posted as of Apr 18, 2022