Status:
COMPLETED
Sexual Intercourse and Vaginal Absorption of Progesterone
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
IBSA Institut Biochimique SA
Ferring Pharmaceuticals
Conditions:
Infertility
Eligibility:
All Genders
18+ years
Phase:
NA
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 p...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 29 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05232344
Start Date
April 13 2022
End Date
February 29 2024
Last Update
March 4 2024
Active Locations (1)
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1
CHU de Montpellier
Montpellier, France, 34295