Modification of Endometrial Receptivity After Vaginal Seminal Plasma Application

Not Applicable

Active, not recruiting

• Conditions: Endometrial Receptivity
• Interventions: Other: seminal plasma; Other: saline solution

• Registration Number: NCT04286425
• Lead Sponsor: Odense University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-27
• Study Start: 2020-09-01
• Primary Completion: 2022-12-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-01
• Last Update Posted: 2023-11-02
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
seminal plasma	seminal plasma	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
Placebo	saline solution	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

Primary Outcome Measures

Name	Time	Method
Endometrial transcriptome profile: mRNA array (fold change)	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)	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.

Secondary Outcome Measures

Name	Time	Method
clinical pregnancy rate	6 months	clinical pregnancy rate difference between treated and control group ( presence of a fetal heartbeat at 6-7 weeks of pregnancy)
pregnancy rate	12 months	pregnancy rate difference between treated and control group (number of live birth)
Endometrial proteins concentration	24 months	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.

Trial Locations

Locations (1)

Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital; 🇩🇰 Odense, Denmark