Modification of Endometrial Receptivity After Vaginal Seminal Plasma Application

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.

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 Overview

• Status: Active, not recruiting
• Conditions: Endometrial Receptivity
• Intervention / Treatment: Other: saline solution; Other: seminal plasma

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jens Fedder; Phone Number: +45 26820368; Email: fedder@dadlnet.dk

Study Locations

• Denmark
  • Odense, Denmark, DK-5000
    • Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 500 µl of saline solution applied in the vaginal volt twice : one month before the IVF procedure during the ovulation period; Same month of the IVF procedure after ovum pick up	Other: saline solution; saline solution
Active Comparator: seminal plasma; 500 µl of seminal plasma applied in the vaginal volt twice : one month before the IVF procedure during the ovulation period; Same month of the IVF procedure after ovum pick up	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
pregnancy rate	pregnancy rate difference between treated and control group (number of live birth)	12 months

Collaborators and Investigators

• Sponsor: Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): December 30, 2022
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: endometrium; fertility; seminal plasma
• Other Study ID Numbers: Lab.Reprod.Biol. - Odense.05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No