Infertility
Conditions
Keywords
Progesterone, Vaginal absoption, Intercourse, Assisted reproductive technology
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?
Interventions
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).
BEHAVIORALSexual 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.
Sponsors
IBSA Institut Biochimique SA
Ferring Pharmaceuticals
University Hospital, Montpellier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France
Outcome results
None listed