Endometrial Receptivity
Conditions
Keywords
fertility, seminal plasma, endometrium
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.
Interventions
OTHERseminal 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
OTHERsaline solution
saline solution
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) |
Countries
Denmark
Outcome results
None listed