Modification of Endometrial Receptivity After Vaginal Seminal Plasma Application

NCT ID: NCT04286425

Last Updated: 2023-11-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2023-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

saline solution

Intervention Type: OTHER

saline solution

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

Group Type: ACTIVE_COMPARATOR

seminal plasma

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

saline solution

saline solution

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jens Fedder

Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Odense, , Denmark

Countries

Denmark

Other Identifiers

Lab.Reprod.Biol. - Odense.05

Identifier Type: -

Identifier Source: org_study_id