Sexual Intercourse and Vaginal Absorption of Progesterone

Infertility Clinical Trial

— SexVAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05232344
• Other study ID #: RECHMPL21_0182
• Secondary ID: 2021-A01552-39
• Status: Completed
• Phase: N/A
• Start date: April 13, 2022
• Est. completion date: February 29, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 29, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (ßHCG 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

Related Conditions & MeSH terms

• Infertility

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Montpellier	Montpellier

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Ferring Pharmaceuticals, IBSA Institut Biochimique SA

Country where clinical trial is conducted

France, 

References & Publications (10)

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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: Hum Reprod. 2018 Jan 1;33(1):178. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline progesterone (Day 2) at Day 3
Primary	Progesterone dosage 2	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	Change from Baseline progesterone (Day 2) at Day 7