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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
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
Centre of Andrology & Fertility Clinic, Department D, Odense University Hospital
Odense, Denmark
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.
Time frame: 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.
Time frame: 24 months
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.
Time frame: 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)
Time frame: 6 months
pregnancy rate
pregnancy rate difference between treated and control group (number of live birth)
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.