Seminal fluid and reproductive health in women

Seminal fluid as a determinant of reproductive health in healthy women: a study to investigate the effects of seminal fluid on cytokine gene expression and protein synthesis in cervical and endometrial tissue

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000040066

Enrollment

Registered

2010-01-14

Start date

2009-12-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Healthy reproductive function is essential for conception and pregnancy. We have discovered that male seminal fluid can influence the female reproductive system after coitus. This project will define the actions of seminal fluid in the cervix and uterus, and the impact on fertility and defence against sexually transmitted infection. The findings will provide new insight on how men contribute to reproductive health in women, and lead to improved treatments for infertility and miscarriage. On the basis of our extensive studies on the female response to seminal fluid in animal models, and observations to date in human tissues, we hypothesise that in women, male seminal fluid interacts with epithelial cells lining the cervix and endometrium to activate a similar but distinct inflammatory cytokine response in both tissues.

Interventions

Participants will be involved in this study for 2 menstrual cycles only,comprising a control cycle and an intervention cycle. Arm 1 of this study is the intervention cycle during which participants will be randomised to have either (group a) intercourse at least once using condoms, (group b)intercourse at least once without condoms, or (group c) abstain from sexual intercourse. Intercourse will be timed to occur (group a and b) or not (group c) at time of Lutenising Hormone (LH) surge in menstrual cycle and endometrial biopsy will collected 10 - 12 hours after intercourse. During the cycle up to the time of randomisation and group allocation they will be required to abstain from intercourse or use a condom, to prevent contamination of the endometrium with seminal fluid. Arm 2 of the study is the control cycle during which an endometrial biopsy will be collected at time of LH surge, with out seminal fluid present. To aviod contamination of the endometrium with seminal fluid participants will be be able to chose to abstain from sexual intercourse or wear condoms for the duration of the cycle. There is no requirement for a washout period between cycles but there can be no longer than 3 months between intervention and control cycle. Total duration of participation in the study is 8 weeks (2 x 4week cycles)

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Diagnosis

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

healthy volunteer women having regular menstrual cycles (26-32 days) have undergone or planning to have a tubal ligation have a partner with proven fertility, (paternity in another relationship is allowed) be currently sexually active

Exclusion criteria

women using steroidal contraceptives, an intrauterine device contraception during the preceding two months. Barrier contraception is allowed. women with active symptoms of infection women whose partners are vasectomised or azoospermic

Outcome results