Transplantation of Vaginal Mikrobiome

06.12.2021 - Amendment to protocol. A subgroup of 24 women included in the main study as recipients, were asked to participate in delivery of menstrual blood (2-3 times) and peripheral blood (2-3 times). This to analyse immunological cells via flowcytometry in women with vaginal dysbiosis and if there is a change after engraftment of the VMT product.

17.05.2022 - Amendment to protocol. Those/if any women who did not convert their vaginal microbiome is asked to participate in a substudy with 2 arms. Local pretreatment with antiseptic and saline water before VMT and local pretreatment with saline water before VMT.

26.09.2022 - Amendment to protocol. Study arm with only pretreatment of antiseptic was added to the amendment from the 17.05.2022.

Inclusion criteria

Donor:

• a woman between 18 and 40 years old;
• generally healthy and do not suffer from an immunological or other chronic diseases;
• have regular menstruation or do not menstruate due to birth control pills, gestagen pills (mini-pills), etonogestrel birth control implant or hormone IUD;
• not or do not have a desire to become pregnant within the next year;
• willing to be asked personal questions in the form of medical history, current use of medication, sexuality and sexual behavior;
• willing to refrain from vaginal intercourse unless a condom is used during certain periods of participation; and
• can read and understand information material in Danish or English.
• Accept not to use any intravaginal products such as tampons, menstrual cup, sex toys, vaginal cleaning products, spermicide products and vaginal lubrication.

Recipient:

• a woman between 18 and 40 years old;
• generally healthy and do not suffer from an immunological or other chronic diseases;
• have regular menstruation or do not menstruate due to birth control pills, gestagen pills (mini-pills), etonogestrel birth control implant or hormone IUD;
• not or do not have a desire to become pregnant within the next year;
• willing to be asked personal questions in the form of medical history, current use of medication, sexuality and sexual behavior;
• willing to refrain from vaginal intercourse unless a condom is used during certain periods of participation; and
• can read and understand information material in Danish or English.
• Accept not to use any intravaginal products such as tampons, menstrual cup, sex toys, vaginal cleaning products, spermicide products and vaginal lubrication.

Exclusion criteria

Donor:

• Being pregnant
• Any medical history of bacterial vaginosis, Trichomoniasis, Syphilis, HPV, herpes, intraabdominal infections, recurrent urine infections or Mycoplasma infections.
• Positive test result of HIV, Hepatitis A, B and C, Chlamydia, Gonorré, Mycoplasma, Trichonomas, HPV, herpes simplex and Streptococcus A, B, C and G.
• Currently pregnant or lactating.
• Any history of Gonorré and/or Chlamydia during the last year.
• Have been travelling or have had a sexual partner who has been travelling to countries with Ebola and/or Zika virus within the last year.
• Any other medical history, current use of medicine, travels or behavior which from a doctor's perspective is considered not suitable for being a donor.
• Hysterectomized
• Have participated in other medical studies within the last 30 days
• Removal of IUD, cervical cryotheraphy or cervical laser-treatment up until 3 months before screening.
• Any condition requiring the use of antibiotics in the investigation period
• Usage of long-acting hormonal therapy within the last 3 months prior to screening.
• Any social, medical or psychological condition including any history of drug and alcohol abuse, where it is evaluated that the participant cannot adhere to the protocol
• Unsatisfying examination and screening results evaluated by a doctor
• Any sexual habits, history or sexual partner, where the behavior can lead to an increased risk of sexual infections.
• Usage of medicine, recently vaccinated or other behavior which is considered to be a hinder for participation.

Recipient:

• Being pregnant
• Planning to become pregnant within the next 6 months
• Lactating
• Being less than 8 weeks post partum
• Known positive HIV/AIDS infection or other immune diseases
• Positive test result of HIV, Hepatitis A, B and C, Chlamydia, Gonorré, Mycoplasma, Trichonomas, positive urine hCG and HPV.
• Have participated in other medical studies within the last 30 days
• Removal of IUD, cervical cryotheraphy or cervical laser-treatment up until 3 months before screening.
• Any condition requiring the use of antibiotics in the investigation period
• Usage of long-acting hormonal therapy within the last 3 months prior to screening.
• Any social, medical or psychological condition including any history of drug and alcohol abuse, where it is evaluated that the participant cannot adhere to the protocol
• Unsatisfying examination and screening results evaluated by a doctor