Endometrial ReceptivityNCT04286425
Modification of Endometrial Receptivity After Vaginal Seminal Plasma Application
A study testing seminal plasma and saline solution in people with Endometrial Receptivity, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The aim of the project is to investigate the effect of seminal plasma on the endometrium and to evaluate changes in the endometrial receptivity after exposure to seminal plasma. Implantation is still an important limiting factor for the improvement of pregnancy rate in the Assisted Reproductive Technology (ART). Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrial Receptivity
- What is being tested?
- seminal plasma and saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2020to 30 Dec 2023
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy lesbian and single women receiving IVF assisted reproduction treatment at OUH Fertility Clinic
Who cannot join
- Language problems to such an extent that subjects do not understand the scope of the study.
- Abnormal high follicle-stimulating hormone
- severe endometriosis,
- severe polycystic ovarian syndrome
- chronic diseases
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital
Odense, DK-5000
About this study
Official title: Modification of Endometrial Receptivity After Vaginal Seminal Plasma Application: a Randomized Clinical Trial
The aim of the project is to investigate the effect of seminal plasma on the endometrium and to evaluate changes in the endometrial receptivity after exposure to seminal plasma.
Implantation is still an important limiting factor for the improvement of pregnancy rate in the Assisted Reproductive Technology (ART). Usually, in fertility clinics, only the spermatozoa are used for the treatments while the rest of the seminal fluid is discarded. However, the importance of seminal fluid in fertility has gained interest in the last years but no conclusive that has been obtained yet.
Read more
Experimental group:
We decided to focus our attention on lesbian couples and single women undergoing ART procedures because they could benefice the most from this treatment since they usually do not have contact with seminal plasma. Moreover, to the best of our knowledge, they have more problems in achieving a pregnancy than heterosexual couples. Our observation is supported by a preliminary analysis of data from the Dansk fertilitetsselskab.
Design Randomized, double-blinded, placebo-controlled study
- Group 1 treated: 20 healthy lesbian or single women receiving assisted reproduction
- Group 2 control: 20 healthy lesbian or single women receiving assisted reproduction
Treatment
- One month before the IVF procedure: First seminal plasma/placebo application during ovulation period
- Same month of the IVF procedure: second seminal plasma/placebo application after ovum pick up 5 days after the first application an endometrial biopsy and one blood sample will be taken for analysis.
Analysis:
Endometrial transcriptome microarray analysis that will be verified through protein analysis.
Differences in the transcriptome between the two groups will be compared with data in literature for an optimal endometrial receptivity. Moreover, clinical pregnancy rate and pregnancy outcome will be compared.
- Conditions
- Endometrial Receptivity
- Being tested
- seminal plasma, saline solution
- Keywords
- fertility, seminal plasma, endometrium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
seminal plasmaOther
Seminal plasma free of sperm, from donor men with normal sperm parameters, and tested for HIV1, HIV2, Hepatitis B, Hepatitis C, Syphilis, Chlamydia and Gonorrhea on blood and urine
saline solutionOther
saline solution
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 500 µl of saline solution applied in the vaginal volt twice :
1. one month before the IVF procedure during the ovulation period
2. Same month of the IVF procedure after ovum pick up Receives: Other: saline solution |
| seminal plasma | Active comparator | 500 µl of seminal plasma applied in the vaginal volt twice :
1. one month before the IVF procedure during the ovulation period
2. Same month of the IVF procedure after ovum pick up Receives: Other: seminal plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial transcriptome profile: mRNA array (fold change)
mRNA array ( fold change). Endometrial mRNA expression will be compared between treated and control group mRNA expression expression will be compared between treated and control group mRNA expression profiles will be compared with literature data for an optimal endometrial receptivity.
Measured: 24 months
Endometrial protein concentration of leukemia inhibitory factor (LIF)
LIF concentration measured by ELISA test. LIF concentration will be compared between treated and control group. LIF has been chosen for its importance in implantation.
Measured: 24 months
Secondary outcomes (3)
Endometrial proteins concentration
protein concentration of relevant genes selected after transcriptome analysis will be measured using ELISA test. Proteins concentration will be compared between treated and control group.
Measured: 24 months
clinical pregnancy rate
clinical pregnancy rate difference between treated and control group ( presence of a fetal heartbeat at 6-7 weeks of pregnancy)
Measured: 6 months
pregnancy rate
pregnancy rate difference between treated and control group (number of live birth)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start1 Sep 2020
- Primary completion30 Dec 2022
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial ReceptivityStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens Fedder, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286425
- Sponsor's protocol ID
- Lab.Reprod.Biol. - Odense.05
- Status last verified
- Nov 2023
- First submitted
- 14 Feb 2020
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Endometrial Receptivity After Vaginal Seminal Plasma Application: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04286425
- Acronym / sponsor ID
- Lab.Reprod.Biol. - Odense.05
- Conditions
- Endometrial Receptivity
- Keywords
- fertility, seminal plasma, endometrium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 27 Feb 2020 (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 aim of the project is to investigate the effect of seminal plasma on the endometrium and to evaluate changes in the endometrial receptivity after exposure to seminal plasma.
Implantation is still an important limiting factor for the improvement of pregnancy rate in the Assisted Reproductive Technology (ART). Usually, in fertility clinics, only the spermatozoa are used for the treatments while the rest of the seminal fluid is discarded. However, the importance of seminal fluid in fertility has gained interest in the last years but no conclusive that has been obtained yet.
Experimental group:
We decided to focus our attention on lesbian couples and single women undergoing ART procedures because they could benefice the most from this treatment since they usually do not have contact with seminal plasma. Moreover, to the best of our knowledge, they have more problems in achieving a pregnancy than heterosexual couples. Our observation is supported by a preliminary analysis of data from the Dansk fertilitetsselskab.
Design Randomized, double-blinded, placebo-controlled study
- Group 1 treated: 20 healthy lesbian or single women receiving assisted reproduction
- Group 2 control: 20 healthy lesbian or single women receiving assisted reproduction
Treatment
- One month before the IVF procedure: First seminal plasma/placebo application during ovulation period
- Same month of the IVF procedure: second seminal plasma/placebo application after ovum pick up 5 days after the first application an endometrial biopsy and one blood sample will be taken for analysis.
Analysis:
Endometrial transcriptome microarray analysis that will be verified through protein analysis.
Differences in the transcriptome between the two groups will be compared with data in literature for an optimal endometrial receptivity. Moreover, clinical pregnancy rate and pregnancy outcome will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: saline solution500 µl of saline solution applied in the vaginal volt twice : 1. one month before the IVF procedure during the ovulation period 2. Same month of the IVF procedure after ovum pick up |
| seminal plasma | Active comparator | Other: seminal plasma500 µl of seminal plasma applied in the vaginal volt twice : 1. one month before the IVF procedure during the ovulation period 2. Same month of the IVF procedure after ovum pick up |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy lesbian and single women receiving IVF assisted reproduction treatment at OUH Fertility Clinic
Key exclusion criteria (5 listed)
- Language problems to such an extent that subjects do not understand the scope of the study.
- Abnormal high follicle-stimulating hormone
- severe endometriosis,
- severe polycystic ovarian syndrome
- chronic diseases
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 |
|---|---|---|
| seminal plasmaSeminal plasma free of sperm, from donor men with normal sperm parameters, and tested for HIV1, HIV2, Hepatitis B, Hepatitis C, Syphilis, Chlamydia and Gonorrhea on blood and urine | Other | seminal plasma |
| saline solutionsaline solution | Other | Placebo |
Primary outcome
Endometrial transcriptome profile: mRNA array (fold change)
Time frame: 24 months
mRNA array ( fold change). Endometrial mRNA expression will be compared between treated and control group mRNA expression expression will be compared between treated and control group mRNA expression profiles will be compared with literature data for an optimal endometrial receptivity.
Endometrial protein concentration of leukemia inhibitory factor (LIF)
Time frame: 24 months
LIF concentration measured by ELISA test. LIF concentration will be compared between treated and control group. LIF has been chosen for its importance in implantation.
3 secondary outcomes
Endometrial proteins concentration
Time frame: 24 months
clinical pregnancy rate
Time frame: 6 months
pregnancy rate
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing seminal plasma and saline solution in people with Endometrial Receptivity, run by Odense University Hospital at 1 site in Denmark.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 2 Nov 2023. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Endometrial transcriptome profile: mRNA array (fold change) (time frame: 24 months). 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?
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 2 Nov 2023.