Sexual Intercourse and Vaginal Absorption of Progesterone

NCT05232344 | Completed

• 2 other identifiers: RECHMPL21_01822021-A01552-39
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

Progesterone; Vaginal absoption; Intercourse; Assisted reproductive technology

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Estradiol / Progesterone treatment

EXPERIMENTAL

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; Behavioral: Sexual event

Interventions

Estradiol / Progesterone DRUG

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).

Estradiol / Progesterone treatment

Sexual event BEHAVIORAL

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.

Estradiol / Progesterone treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• aged 18 to 40 inclusive

You may not qualify if:

• 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
• Erectile or ejaculatory disorder
• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• IBSA Institut Biochimique SA: collaborator
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

CHU de Montpellier

Montpellier, 34295, France

Location

Related 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.

  PMID: 30385142 BACKGROUND

• 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.

  PMID: 10711552 BACKGROUND

• 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.

  PMID: 30642638 BACKGROUND

• 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.

  PMID: 30585507 BACKGROUND

• 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.

  PMID: 15763615 BACKGROUND

• 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.

  PMID: 29040638 BACKGROUND

• 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.

  PMID: 25713585 BACKGROUND

• 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.

  PMID: 23127204 BACKGROUND

• 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.

  PMID: 26148507 BACKGROUND

• 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.

  PMID: 26099447 BACKGROUND

MeSH Terms

Conditions

Infertility; Coitus

Interventions

Estradiol; Progesterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnenediones; Pregnenes; Pregnanes; Corpus Luteum Hormones; Progesterone Congeners

Study Officials

• Noémie RANISAVJLEVIC, MD

  CHU de Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 9, 2022
• Study Start: April 13, 2022
• Primary Completion: February 5, 2024
• Study Completion: February 29, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)