Modification of Endometrial Receptivity After Vaginal Seminal Plasma Application

Endometrial Receptivity Clinical Trial

Official title:

Modification of Endometrial Receptivity After Vaginal Seminal Plasma Application: a Randomized Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04286425
• Other study ID #: Lab.Reprod.Biol. - Odense.05
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2023
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy lesbian and single women receiving IVF assisted reproduction treatment at OUH Fertility Clinic

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Endometrial Receptivity

Intervention

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
• saline solution
saline solution

Locations

Country	Name	City	State
Denmark	Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months
Primary	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.	24 months
Secondary	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.	24 months
Secondary	clinical pregnancy rate	clinical pregnancy rate difference between treated and control group ( presence of a fetal heartbeat at 6-7 weeks of pregnancy)	6 months
Secondary	pregnancy rate	pregnancy rate difference between treated and control group (number of live birth)	12 months