Clinical trial NCT05232344: Sexual Intercourse and Vaginal Absorption of Progesterone
Official title: Sexual Intercourse and Vaginal Absorption of Progesterone : Cross-over Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: Progesterone
Vaginal absoption
Intercourse
Assisted reproductive technology
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: IBSA Institut Biochimique SA
name: Ferring Pharmaceuticals
First posted: 2022-02-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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?

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

Primary outcomes:
measure: Progesterone dosage 1
timeFrame: Change from Baseline progesterone (Day 2) at Day 3
measure: Progesterone dosage 2
timeFrame: Change from Baseline progesterone (Day 2) at Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU de Montpellier
Study officials:
affiliation: CHU de Montpellier
name: Noémie RANISAVJLEVIC, MD
role: STUDY_DIRECTOR
References:
citation: Alsbjerg B, Thomsen L, Elbaek HO, Laursen R, Povlsen BB, Haahr T, Humaidan P. Progesterone levels on pregnancy test day after hormone replacement therapy-cryopreserved embryo transfer cycles and related reproductive outcomes. Reprod Biomed Online. 2018 Nov;37(5):641-647. doi: 10.1016/j.rbmo.2018.08.022. Epub 2018 Oct 6.
citation: Cicinelli E, de Ziegler D, Bulletti C, Matteo MG, Schonauer LM, Galantino P. Direct transport of progesterone from vagina to uterus. Obstet Gynecol. 2000 Mar;95(3):403-6. doi: 10.1016/s0029-7844(99)00542-6.
citation: Cedrin-Durnerin I, Isnard T, Mahdjoub S, Sonigo C, Seroka A, Comtet M, Herbemont C, Sifer C, Grynberg M. Serum progesterone concentration and live birth rate in frozen-thawed embryo transfers with hormonally prepared endometrium. Reprod Biomed Online. 2019 Mar;38(3):472-480. doi: 10.1016/j.rbmo.2018.11.026. Epub 2019 Jan 5.
citation: Gaggiotti-Marre S, Martinez F, Coll L, Garcia S, Alvarez M, Parriego M, Barri PN, Polyzos N, Coroleu B. Low serum progesterone the day prior to frozen embryo transfer of euploid embryos is associated with significant reduction in live birth rates. Gynecol Endocrinol. 2019 May;35(5):439-442. doi: 10.1080/09513590.2018.1534952. Epub 2018 Dec 26.
citation: Hussain A, Ahsan F. The vagina as a route for systemic drug delivery. J Control Release. 2005 Mar 21;103(2):301-13. doi: 10.1016/j.jconrel.2004.11.034. Epub 2005 Jan 13.
citation: Labarta E, Mariani G, Holtmann N, Celada P, Remohi J, Bosch E. Low serum progesterone on the day of embryo transfer is associated with a diminished ongoing pregnancy rate in oocyte donation cycles after artificial endometrial preparation: a prospective study. Hum Reprod. 2017 Dec 1;32(12):2437-2442. doi: 10.1093/humrep/dex316.
citation: Merriam KS, Leake KA, Elliot M, Matthews ML, Usadi RS, Hurst BS. Sexual absorption of vaginal progesterone: a randomized control trial. Int J Endocrinol. 2015;2015:685281. doi: 10.1155/2015/685281. Epub 2015 Feb 3.
citation: Sator M, Radicioni M, Cometti B, Loprete L, Leuratti C, Schmidl D, Garhofer G. Pharmacokinetics and safety profile of a novel progesterone aqueous formulation administered by the s.c. route. Gynecol Endocrinol. 2013 Mar;29(3):205-8. doi: 10.3109/09513590.2012.736560. Epub 2012 Nov 6.
citation: van der Linden M, Buckingham K, Farquhar C, Kremer JA, Metwally M. Luteal phase support for assisted reproduction cycles. Cochrane Database Syst Rev. 2015 Jul 7;2015(7):CD009154. doi: 10.1002/14651858.CD009154.pub3.
citation: Yovich JL, Conceicao JL, Stanger JD, Hinchliffe PM, Keane KN. Mid-luteal serum progesterone concentrations govern implantation rates for cryopreserved embryo transfers conducted under hormone replacement. Reprod Biomed Online. 2015 Aug;31(2):180-91. doi: 10.1016/j.rbmo.2015.05.005. Epub 2015 May 18.