Plain English Summary
Background and study aims
There is a suggestion that seminal plasma (seminal fluid with no sperm) may play a role in the egg implanting into the womb. In patients undergoing fertility treatment to help them have a baby, such as in-vitro fertilization (IVF) or intra-cytoplasmatic injection (ICSI), seminal fluid does not come into contact with the womb, as embryos are transferred without seminal plasma and patients usually abstain (or advised to abstain) from sexual intercourse for several days both before and after egg retrieval. Seminal fluid contains several proteins that interact with cells in the endometrium (lining of the womb) to induce a cascade which activates maternal immune activity to accept the 'invading' embryo. Animal and human studies have suggested that when participants are inserted with seminal plasma during fertility treatment they have higher levels of conception in comparison to their controls. The aim of this study is to investigate whether seminal plasma injected into the uterine cavity during fertility treatment improves clinical pregnancy rates.
Who can participate?
Patients aged between 23 and 39 years old undergoing IVF at the Homerton Fertility Centre who are undergoing their first or second cycle of IVF using their partner’s fresh sperm for their IVF cycle and not sperm that has been frozen or that comes from a donor.
What does the study involve?
Participants are randomly allocated to one of two groups on the day that eggs are collected from the woman to fertilise with her partner's sperm to create an embryo in the lab. As usual procedure the male partner’s sperm will be separated from the seminal fluid in the laboratory. Usually the remaining fluid will be discarded by the embryologist. However, for this researches purpose they will not be discarded. After egg collection, if the patient is in the first group they receive 0.5 ml of their partner's seminal fluid by injection into their womb. Those in the other group receive a 0.5 ml injection of placebo (dummy) fluid. This procedure takes less than 2-3 minutes. Treatment before and after the day of egg collection is completely routine. One month after the study, pregnancy results are recorded.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating in this study.
Where is the study run from?
Homerton Fertility Centre (UK)
When is study starting and how long is it expected to run for?
July 2013 and October 2015
Who is funding the study?
Homerton Fertility Centre (UK)
Who is the main contact?
Dr Giselle Crawford
giselle.crawford@health.nsw.gov.au
Trial website
Contact information
Type
Scientific
Primary contact
Dr Giselle Crawford
ORCID ID
Contact details
The Royal Hospital for Women
Barker Street
Randwick NSW
2031
Australia
+61 2 9382 6100
giselle.crawford@health.nsw.gov.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effect of intrauterine injection of seminal plasma on IVF results: A prospective double-blind randomized placebo-controlled trial
Acronym
Study hypothesis
There is improved clinical pregnancy and live birth rates when patients are exposed to seminal plasma at the time of oocyte pickup during an IVF cycle.
Ethics approval
London – South East REC, 03/02/2014, ref: 13/LO/1835
Study design
Single-centre prospective double-blind randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Infertility requiring in vitro fertilisation for its management
Intervention
Participants are randomized on the day of oocyte pick-up to one of two groups with the use of a computer-generated random number sequence and opaque sealed envelopes by the lead Embryologist. On the morning of the scheduled oocyte aspiration, opaque sealed envelopes are opened consecutively by the lead Embryologist. Once prepared, the blinded sample is transferred to the operating theatre by the Embryologist and handed to the physician for intrauterine injection.
Intervention group: Participants receive 0.5µL aliquot of their partner's seminal plasma injected into their uterine cavity at the time of their scheduled oocyte pick-up.
Control group: Participants receive 0.5µL of Quinn's Sperm Wash Media (Sage Origio, Måløv, Denmark) injected into their uterine cavity at the time of their scheduled oocyte pick-up.
The follow up for trial participants is routine as for any patient undergoing an IVF cycle within the unit. It includes a serum pregnancy test two weeks after oocyte pickup and if this was positive a pelvic ultrasound is performed five weeks after oocyte pickup. All patients undergoing fertility treatment in our centre routinely have their live birth data collated by the unit.
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measure
Clinical pregnancy rate (CPR) is assessed via pelvic ultrasound at 7-8 weeks gestation.
Secondary outcome measures
1. Miscarriage rate is measured by pelvic ultrasound at 7-8 weeks gestation
2. Multiple pregnancy rate is assessed via pelvic ultrasound at 7-8 weeks gestation
3. Live birth rate (LBR) is determined through medical record review at three months after the expected date of delivery (routinely collected for all patients undergoing fertility treatment within the unit)
Overall trial start date
01/07/2013
Overall trial end date
31/10/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients undergoing IVF or ICSI treatment at the Homerton University Hospital, London, between February 2014 and September 2014
2. Female partner aged 23-39 years and with any cause infertility
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. The couple having undergone a prior cycle with failed fertilization
2. The use of donor oocytes or frozen-thawed sperm
3. The presence of hepatitis B, hepatitis C, or HIV infections; leucospermia or other signs of infection
4. Men with <500 µl of SP
5. Enrollment in conflicting studies
Recruitment start date
03/02/2014
Recruitment end date
31/10/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Homerton Fertility Centre
Homerton Row
Homerton
London
E96SR
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Homerton Fertility Centre
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The preliminary results of this study were presented at the RCOG (Royal College of Obstetrics & Gynaecology) World Congress in Brisbane Australia in April 2015. Plans to submit the paper including the live birth results to Human Reproduction for publication.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Giselle Crawford (giselle.crawford@health.nsw.gov.au)
Intention to publish date
31/12/2016
Participant level data
Available on request
Basic results (scientific)
Publication list