Advice to have sexual intercourse before embryo transfer and its effect on the pregnancy rate
| ISRCTN | ISRCTN11503599 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11503599 |
- Submission date
- 20/08/2025
- Registration date
- 27/08/2025
- Last edited
- 26/08/2025
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Around 1 in 6 couples worldwide experience fertility issues. The use of IVF (commonly known as “test tube baby” treatment) has grown significantly, with millions of treatment cycles now performed each year. Most of these involve transferring embryos that were previously frozen. Recent research suggests that sperm and seminal fluid may help prepare the womb for embryo implantation, potentially improving the chances of pregnancy. Even protected sex (using a condom) may have a positive effect. This study aims to find out whether having vaginal sex in the four days before embryo transfer can increase the chances of getting pregnant.
Who can participate?
Women who are undergoing frozen embryo transfer at the UMMC fertility clinic may be eligible if:
-They are on a medicated frozen embryo transfer cycle
-Their womb lining is at least 8mm thick with a healthy appearance on ultrasound
-They are having embryos transferred that were frozen at 5 days old
What does the study involve?
Participants will be randomly placed into one of two groups:
One group will be advised to have vaginal sex in the four days before embryo transfer
The other group will be advised to avoid vaginal sex during the IVF cycle
Participants will be asked to keep a diary of any vaginal intercourse during the study.
What are the possible benefits and risks of participating?
Benefits:
Vaginal sex may help improve the chances of pregnancy
It may also support emotional wellbeing during the IVF process
Risks:
There is a possibility that vaginal sex could reduce the chances of pregnancy
Where is the study run from?
The study is being run at the fertility clinic at UMMC (University of Malaya Medical Centre) (Malaysia)
When is the study starting and how long is it expected to run for?
February 2025 to December 2026
Who is funding the study?
UMMC (University of Malaya Medical Centre) (Malaysia)
Who is the main contact?
Dr Atikah binti Mohamed Halim, atikah.halim@ummc.edu.my
Contact information
Public, Scientific, Principal Investigator
12 Jalan Aman Taman Robina
Butterworth
13050
Malaysia
 ORCID ID |
0009-0006-4131-0613 |
|---|---|
| Phone | +60124907422 |
| atikah.halim@ummc.edu.my |
Study information
| Study design | A single center parallel group randomized controlled trial with convenience sampling |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 47869_PIS_v2.0_21July2025.pdf |
| Scientific title | Advising sexual intercourse before embryo transfer: a randomized controlled trial |
| Study acronym | SIET-PR |
| Study objectives | Advising sexual intercourse in the 96 hours prior to embryo transfer will increase pregnancy rate |
| Ethics approval(s) |
Approved 30/07/2025, Local Institutional Review Board (IRB)/ Independent Ethic Committee (IEC) University Malaya Medical Centre (University Malaya Medical Centre (UMMC), Kuala Lumpur, 59100, Malaysia; +60379494422; ummc-mrec@ummc.edu.my), ref: 2025116-14614 |
| Health condition(s) or problem(s) studied | In-vitro fertilization |
| Intervention | All patients decided for Frozen Embryo Transfer (FET) will be identified, informed consent taken at the start of FET cycle, and the randomization will be performed only when endometrial thickness reached >8mm. Participants will be randomized to A) Advised to engage in sexual intercourse in the 96 hours prior to the embryo transfer or B) Advised to abstain from sexual intercourse through the current IVF cycle Randomization sequence will be generated online using https://www.sealedenvelope.com /simple-randomiser/v1, in blocks of 4 or 8, following 1 to 1 ratio by a researcher who will not be involved in the recruitment process. Allocation will be sealed in a numbered opaque envelope. The lowest numbered envelopes still available will be allocated to the latest recruit. Follow up for 10 weeks after embryo transfer. |
| Intervention type | Behavioural |
| Primary outcome measure | Viable pregnancy with evidence of intra-uterine gestation sac/sacs and presence of fetal heart/hearts activity at 10 weeks after embryo transfer |
| Secondary outcome measures | 1. Implantation rate - the number of gestational sacs observed by ultrasound divided by the number of embryos transferred (usually expressed as a percentage) at 10 weeks after embryo transfer 2. Miscarriage rate - non viable pregnancy diagnosed by ultrasound at 10 weeks after embryo transfer 3. Ectopic pregnancy diagnosed by ultrasound or laparoscopically at 10 weeks after embryo transfer 4. Multiple pregnancies diagnosed by ultrasound scan at 10 weeks after embryo transfer 5. Biochemical pregnancy - serum HCG (>50IU/ml) at 2 weeks after embryo transfer |
| Overall study start date | 14/02/2025 |
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 42 Years |
| Sex | Female |
| Target number of participants | 220 |
| Key inclusion criteria | 1. Women undergoing for frozen embryo transfer 2. Medicated frozen embryo transfer cycle 3. Endometrial thickness > 8mm on starting the luteal phase support with trilaminar appearance on sonography 4. Embryo transfer (embryo frozen at day 5) |
| Key exclusion criteria | 1. Fresh embryo transfer 2. Transfer of 3 or more embryos |
| Date of first enrolment | 01/10/2025 |
| Date of final enrolment | 01/10/2026 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Wilayah Persekutuan Kuala Lumpur
Kuala Lumpur
59100
Malaysia
Sponsor information
Hospital/treatment centre
Lembah Pantai
Wilayah Persekutuan Kuala Lumpur
Kuala Lumpur
59100
Malaysia
| Phone | +60 3-7949 4422 |
|---|---|
| ummc-mrec@ummc.edu.my | |
| Website | http://www.ummc.edu.my/# |
"ROR" |
https://ror.org/00vkrxq08 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Malaya, University Malaya, Malayan University, UM
- Location
- Malaysia
Results and Publications
| Intention to publish date | 30/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in peer reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 21/07/2025 | 26/08/2025 | No | Yes |
| Protocol file | 05/06/2025 | 26/08/2025 | No | No |
Additional files
Editorial Notes
26/08/2025: Study's existence confirmed by the Medical Research Ethics Committee, University Malaya Medical Centre.
