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Modification of Endometrial Receptivity After Vaginal Seminal Plasma Application

O

Odense University Hospital

Status

Active, not recruiting

Conditions

Endometrial Receptivity

Treatments

Other: seminal plasma
Other: saline solution

Study type

Interventional

Funder types

Other

Identifiers

NCT04286425
Lab.Reprod.Biol. - Odense.05

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

Female

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

40 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
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
Treatment:
Other: saline solution
seminal plasma
Active Comparator group
Description:
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
Treatment:
Other: seminal plasma

Trial contacts and locations

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Central trial contact

Jens Fedder

Data sourced from clinicaltrials.gov

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