Condition category
Pregnancy and Childbirth
Date applied
23/11/2016
Date assigned
24/11/2016
Last edited
23/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

Homerton Fertility Centre

Sponsor details

Homerton University Hospital
London
E96SR
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes