InfertilitySexVAPNCT05232344
Sexual Intercourse and Vaginal Absorption of Progesterone
A study testing Estradiol / Progesterone and Sexual event in people with Infertility, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Estradiol / Progesterone and Sexual event
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 13 Apr 2022to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sexual Intercourse and Vaginal Absorption of Progesterone : Cross-over Prospective Study
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.
Read the 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?
- Conditions
- Infertility
- Being tested
- Estradiol / Progesterone, Sexual event
- Keywords
- Progesterone, Vaginal absoption, Intercourse, Assisted reproductive technology
- Medical subject headings
- Infertility, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol / ProgesteroneDrug
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).
Sexual eventBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Estradiol / Progesterone; Behavioral: Sexual event |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change from Baseline progesterone (Day 2) at Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start13 Apr 2022
- Primary completion5 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- IBSA Institut Biochimique SA, Ferring Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Noémie RANISAVJLEVIC, MD, Study director, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232344
- Sponsor's protocol ID
- RECHMPL21_0182
- Other IDs
- 2021-A01552-39
- Acronym
- SexVAP
- Status last verified
- Feb 2024
- First submitted
- 14 Jan 2022
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30385142Cicinelli 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.
PubMed 10711552Cedrin-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.
PubMed 30642638Gaggiotti-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.
PubMed 30585507Hussain 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.
PubMed 15763615Labarta 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.
PubMed 29040638Merriam 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.
PubMed 25713585Sator 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.
PubMed 23127204van 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.
PubMed 26148507Yovich 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.
PubMed 26099447Ranisavljevic N, Rolland A, Picot MC, Lotierzo M, Herman F, Duraes M, Brouillet S, Anahory T. Sexual intercourse and vaginal absorption of progesterone (SexVAP): a cross-over randomized prospective pilot study. Reprod Biomed Online. 2026 Jan;52(1):105166. doi: 10.1016/j.rbmo.2025.105166. Epub 2025 Jul 18.
PubMed 41285092
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Intercourse and Vaginal Absorption of Progesterone : Cross-over Prospective Study
- ClinicalTrials.gov ID
- NCT05232344
- Acronym / sponsor ID
- SexVAP / RECHMPL21_0182
- Conditions
- Infertility
- Keywords
- Progesterone, Vaginal absoption, Intercourse, Assisted reproductive technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- IBSA Institut Biochimique SA, Ferring Pharmaceuticals
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Estradiol / Progesterone treatment | Experimental | Drug: Estradiol / Progesterone, Behavioral: Sexual eventEstradiol (Provames®, 3 mg morning and evening, or 6 mg per day) Vaginal progesterone (400 mg, Progestan®, evening and morning, ie 800 mg per day). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Estradiol / ProgesteroneTreatment 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). | Drug | Estradiol / Progesterone treatment |
| Sexual eventA 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. | Behavioural | Estradiol / Progesterone treatment |
Primary outcome
Progesterone dosage 1
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Background: PubMed 30385142Alsbjerg 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.
- Background: PubMed 10711552Cicinelli 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.
- Background: PubMed 30642638Cedrin-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.
- Background: PubMed 30585507Gaggiotti-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.
- Background: PubMed 15763615Hussain 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.
- Background: PubMed 29040638Labarta 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.
- Background: PubMed 25713585Merriam 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.
- Background: PubMed 23127204Sator 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.
- Background: PubMed 26148507van 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.
- Background: PubMed 26099447Yovich 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.
- Derived from this study: PubMed 41285092Ranisavljevic N, Rolland A, Picot MC, Lotierzo M, Herman F, Duraes M, Brouillet S, Anahory T. Sexual intercourse and vaginal absorption of progesterone (SexVAP): a cross-over randomized prospective pilot study. Reprod Biomed Online. 2026 Jan;52(1):105166. doi: 10.1016/j.rbmo.2025.105166. Epub 2025 Jul 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noémie RANISAVJLEVIC, MD study director
CHU de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estradiol / Progesterone and Sexual event in people with Infertility, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progesterone dosage 1 (time frame: Change from Baseline progesterone (Day 2) at Day 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05232344, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.