Embryo TransferNCT06134609
Does Sexual Intercourse Affect the Outcomes of Frozen-thawed Embryo Transfer?
A study testing Sexual intercourse in people with Embryo Transfer and Fertilization in Vitro, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The goal of this clinical trial is to test whether sexual intercourse the night after embryo transfer affects thawed embryo implantation rates. Women undergoing one of their first four frozen embryo transfers with a good quality embryo will be randomly assigned to two groups. Read more about this study
- Who is it for?
- Ages 18 to 41 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Embryo Transfer, Fertilization in Vitro, Coitus
- What is being tested?
- Sexual intercourse
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 656 participants
- Where
- 1 siteIsrael
- Study dates
- 13 Nov 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 41 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women age 18-41yrs.
- BMI (body mass index) of 18-35 kg/m².
- Patients undergoing one of their first four frozen embryo transfers.
- Patients transferring a good quality embryo, either a cleavage stage embryo or a day 5 blastocyst.
Who cannot join
- Patients age above 42.
- Moderate or poor-quality embryos.
- Patients with hydrosalpinx or uterus malformations.
- Patients who are not able or are not interested in having vaginal intercourse (same sex couples for example).
- Couples undergoing preimplantation genetic diagnosis when natural cycle frozen embryo transfer is planned (as they are instructed to avoid intercourse).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Dror Dr., MD, 97235305000, dror.lifshitz@sheba.health.gov.il
Dror Lifshitz, MD
About this study
Official title: Does Sexual Intercourse Affect the Outcomes of Frozen-thawed Embryo Transfer? Randomized Controlled Trial
The goal of this clinical trial is to test whether sexual intercourse the night after embryo transfer affects thawed embryo implantation rates. Women undergoing one of their first four frozen embryo transfers with a good quality embryo will be randomly assigned to two groups. The study group is subjected to have intercourse without using a condom at the evening/night after the embryo transfer, while the control group will abstain from intercourse for the next 48 hours after the transfer. Researchers will compare the ongoing pregnancy rates between the intervention group and the control group.
Read the detailed description
It is currently unclear whether sexual intercourse the night after embryo transfer, with or without semen ejaculation, is detrimental to thawed embryo implantation rates.
The following study is a prospective, randomized, clinical trial, including patients attending our university-affiliated Infertility and IVF center.
The goal of this clinical trial is to test whether coitus the night after embryo transfer affects thawed embryo implantation rates. At the day of the embryo transfer women (ages 18-41yrs) undergoing one of their first four frozen embryo transfers with a good quality embryo will be randomly assigned to two groups. The study group is subjected to have intercourse without using a condom at the evening/night after the embryo transfer, while the control group is subjected to abstain for the next 48 hours after the transfer.
The day after the embryo transfer an electronic questionnaire will be sent to the patients to confirm whether they had intercourse or not. The questionnaire will also address whether male ejaculation was performed intravaginally and whether female orgasm occurred.
12-14 days after the embryo transfer a BHCG serum test will be performed. For those patients with a negative BHCG test surveillance will be stopped. For those with a positive BCHG test a gynecologic US will be performed at week 6. After wards surveillance will cease for all participants. Researchers will compare the ongoing pregnancy rates between the intervention group and the control group.
- Conditions
- Embryo Transfer, Fertilization in Vitro, Coitus
- Being tested
- Sexual intercourse
- Keywords
- IVF, Embryo Transfer, Sexual intercourse, Coitus, Pregnancy
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual intercourseBehavioural
Sexual intercourse without barrier contraceptive at the evening/night after the embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| Assigned to intercourse | Experimental | The study group is subjected to perform intercourse without using a condom at the evening/night after the embryo transfer Receives: Behavioral: Sexual intercourse |
| Assigned to abstain | No intervention | The control group is assigned to abstain from coitus the next 48 hours after the embryo transfer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
Ultrasound showing a fetus with a heartbeat
Measured: At 6 week of gestation (4 weeks after embryo transfer)
Secondary outcomes (2)
Biochemical pregnancy rate
Positive BHCG blood test
Measured: 12-14 days after the embryo transfer
Clinical pregnancy rate
Ultrasound confirmation of an intrauterine gestational sac
Measured: At 6 week of gestation (4 weeks after embryo transfer)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start13 Nov 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Embryo TransferStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, clinical trial. Patients will be randomized into two groups (by concealed envelopes). The study group is subjected to have intercourse without using a condom at the evening/night after the embryo transfer, while the control group is subjected to abstain for the next 48 hours after the transfer.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 656 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Dror Lifshitz, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134609
- Sponsor's protocol ID
- SMC-0653-23
- Status last verified
- Nov 2023
- First submitted
- 12 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crawford G, Ray A, Gudi A, Shah A, Homburg R. The role of seminal plasma for improved outcomes during in vitro fertilization treatment: review of the literature and meta-analysis. Hum Reprod Update. 2015 Mar-Apr;21(2):275-84. doi: 10.1093/humupd/dmu052. Epub 2014 Oct 3.
PubMed 25281684Robertson SA, Sharkey DJ. Seminal fluid and fertility in women. Fertil Steril. 2016 Sep 1;106(3):511-9. doi: 10.1016/j.fertnstert.2016.07.1101. Epub 2016 Jul 30.
PubMed 27485480Fanchin R, Righini C, Olivennes F, Taylor S, de Ziegler D, Frydman R. Uterine contractions at the time of embryo transfer alter pregnancy rates after in-vitro fertilization. Hum Reprod. 1998 Jul;13(7):1968-74. doi: 10.1093/humrep/13.7.1968.
PubMed 9740459Saccone G, Di Spiezio Sardo A, Ciardulli A, Caissutti C, Spinelli M, Surbek D, von Wolff M. Effectiveness of seminal plasma in in vitro fertilisation treatment: a systematic review and meta-analysis. BJOG. 2019 Jan;126(2):220-225. doi: 10.1111/1471-0528.15004. Epub 2017 Dec 6.
PubMed 29078039Hou JW, Yuan LH, Cao XL, Song JY, Sun ZG. Impact of sexual intercourse on frozen-thawed embryo transfer outcomes: a randomized controlled trial. Contracept Reprod Med. 2023 Mar 2;8(1):19. doi: 10.1186/s40834-023-00218-y.
PubMed 36859338
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Sexual Intercourse Affect the Outcomes of Frozen-thawed Embryo Transfer? Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06134609
- Acronym / sponsor ID
- SMC-0653-23
- Conditions
- Embryo Transfer, Fertilization in Vitro, Coitus
- Keywords
- IVF, Embryo Transfer, Sexual intercourse, Coitus, Pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 656 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test whether sexual intercourse the night after embryo transfer affects thawed embryo implantation rates. Women undergoing one of their first four frozen embryo transfers with a good quality embryo will be randomly assigned to two groups. The study group is subjected to have intercourse without using a condom at the evening/night after the embryo transfer, while the control group will abstain from intercourse for the next 48 hours after the transfer. Researchers will compare the ongoing pregnancy rates between the intervention group and the control group.
Detailed description
It is currently unclear whether sexual intercourse the night after embryo transfer, with or without semen ejaculation, is detrimental to thawed embryo implantation rates.
The following study is a prospective, randomized, clinical trial, including patients attending our university-affiliated Infertility and IVF center.
The goal of this clinical trial is to test whether coitus the night after embryo transfer affects thawed embryo implantation rates. At the day of the embryo transfer women (ages 18-41yrs) undergoing one of their first four frozen embryo transfers with a good quality embryo will be randomly assigned to two groups. The study group is subjected to have intercourse without using a condom at the evening/night after the embryo transfer, while the control group is subjected to abstain for the next 48 hours after the transfer.
The day after the embryo transfer an electronic questionnaire will be sent to the patients to confirm whether they had intercourse or not. The questionnaire will also address whether male ejaculation was performed intravaginally and whether female orgasm occurred.
12-14 days after the embryo transfer a BHCG serum test will be performed. For those patients with a negative BHCG test surveillance will be stopped. For those with a positive BCHG test a gynecologic US will be performed at week 6. After wards surveillance will cease for all participants. Researchers will compare the ongoing pregnancy rates between the intervention group and the control group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- A prospective, randomized, clinical trial. Patients will be randomized into two groups (by concealed envelopes). The study group is subjected to have intercourse without using a condom at the evening/night after the embryo transfer, while the control group is subjected to abstain for the next 48 hours after the transfer.
| Arm | Type | Receives |
|---|---|---|
| Assigned to intercourse | Experimental | Behavioral: Sexual intercourseThe study group is subjected to perform intercourse without using a condom at the evening/night after the embryo transfer |
| Assigned to abstain | No intervention | –The control group is assigned to abstain from coitus the next 48 hours after the embryo transfer. |
Who may qualify
- Ages
- 18 to 41 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women age 18-41yrs.
- BMI (body mass index) of 18-35 kg/m².
- Patients undergoing one of their first four frozen embryo transfers.
- Patients transferring a good quality embryo, either a cleavage stage embryo or a day 5 blastocyst.
Key exclusion criteria (5 listed)
- Patients age above 42.
- Moderate or poor-quality embryos.
- Patients with hydrosalpinx or uterus malformations.
- Patients who are not able or are not interested in having vaginal intercourse (same sex couples for example).
- Couples undergoing preimplantation genetic diagnosis when natural cycle frozen embryo transfer is planned (as they are instructed to avoid intercourse).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sexual intercourseSexual intercourse without barrier contraceptive at the evening/night after the embryo transfer | Behavioural | Assigned to intercourse |
Primary outcome
Ongoing pregnancy rate
Time frame: At 6 week of gestation (4 weeks after embryo transfer)
Ultrasound showing a fetus with a heartbeat
2 secondary outcomes
Biochemical pregnancy rate
Time frame: 12-14 days after the embryo transfer
Clinical pregnancy rate
Time frame: At 6 week of gestation (4 weeks after embryo transfer)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 25281684Crawford G, Ray A, Gudi A, Shah A, Homburg R. The role of seminal plasma for improved outcomes during in vitro fertilization treatment: review of the literature and meta-analysis. Hum Reprod Update. 2015 Mar-Apr;21(2):275-84. doi: 10.1093/humupd/dmu052. Epub 2014 Oct 3.
- Background: PubMed 27485480Robertson SA, Sharkey DJ. Seminal fluid and fertility in women. Fertil Steril. 2016 Sep 1;106(3):511-9. doi: 10.1016/j.fertnstert.2016.07.1101. Epub 2016 Jul 30.
- Background: PubMed 9740459Fanchin R, Righini C, Olivennes F, Taylor S, de Ziegler D, Frydman R. Uterine contractions at the time of embryo transfer alter pregnancy rates after in-vitro fertilization. Hum Reprod. 1998 Jul;13(7):1968-74. doi: 10.1093/humrep/13.7.1968.
- Background: PubMed 29078039Saccone G, Di Spiezio Sardo A, Ciardulli A, Caissutti C, Spinelli M, Surbek D, von Wolff M. Effectiveness of seminal plasma in in vitro fertilisation treatment: a systematic review and meta-analysis. BJOG. 2019 Jan;126(2):220-225. doi: 10.1111/1471-0528.15004. Epub 2017 Dec 6.
- Background: PubMed 36859338Hou JW, Yuan LH, Cao XL, Song JY, Sun ZG. Impact of sexual intercourse on frozen-thawed embryo transfer outcomes: a randomized controlled trial. Contracept Reprod Med. 2023 Mar 2;8(1):19. doi: 10.1186/s40834-023-00218-y.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual intercourse in people with Embryo Transfer and Fertilization in Vitro, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: At 6 week of gestation (4 weeks after embryo transfer)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06134609, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.