MedTrace Logo

Modification of Endometrial Receptivity After Vaginal Seminal Plasma Application

NCT04286425 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-02

No results posted yet for this study

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). 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.

Conditions

  • Endometrial Receptivity

Interventions

OTHER

seminal plasma

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

OTHER

saline solution

saline solution

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2022-12-30
Completion
2023-12-30

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04286425 on ClinicalTrials.gov