Modification of Endometrial Receptivity After Vaginal Seminal Plasma Application

NCT04286425 | Unknown DMC

• 1 other identifier: Lab.Reprod.Biol. - Odense.05
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

fertility; seminal plasma; endometrium

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Endometrial proteins concentration

  24 months

• clinical pregnancy rate

  6 months

• pregnancy rate

  12 months

Study Arms (2)

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

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

Other: seminal plasma

Interventions

seminal plasma OTHER

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

seminal plasma

saline solution OTHER

saline solution

Placebo

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: It is a study on endometrial factors in female infertility
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital

Odense, DK-5000, Denmark

Location

MeSH Terms

Interventions

Seeds; Saline Solution

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD, PhD

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 27, 2020
• Study Start: September 1, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: November 2, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)