Does Sexual Intercourse Affect the Outcomes of Frozen-thawed Embryo Transfer?

Embryo Transfer Clinical Trial

Official title:

Does Sexual Intercourse Affect the Outcomes of Frozen-thawed Embryo Transfer? Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06134609
• Other study ID #: SMC-0653-23
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2023
• Est. completion date: November 2026

Study information

• Verified date: November 2023
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 656
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 41 Years

Eligibility

Inclusion Criteria:

1. Women age 18-41yrs.

2. BMI (body mass index) of 18-35 kg/m².

3. Patients undergoing one of their first four frozen embryo transfers.

4. Patients transferring a good quality embryo, either a cleavage stage embryo or a day 5 blastocyst.

Exclusion Criteria:

1. Patients age above 42.

2. Moderate or poor-quality embryos.

3. Patients with hydrosalpinx or uterus malformations.

4. Patients who are not able or are not interested in having vaginal intercourse (same sex couples for example).

5. Couples undergoing preimplantation genetic diagnosis when natural cycle frozen embryo transfer is planned (as they are instructed to avoid intercourse).

Related Conditions & MeSH terms

• Coitus
• Embryo Transfer
• Fertilization in Vitro

Intervention

Behavioral:
• Sexual intercourse
Sexual intercourse without barrier contraceptive at the evening/night after the embryo transfer

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (5)

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. — View Citation

Fanchin 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. — View Citation

Hou 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. — View Citation

Robertson 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. — View Citation

Saccone 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	Ultrasound showing a fetus with a heartbeat	At 6 week of gestation (4 weeks after embryo transfer)
Secondary	Biochemical pregnancy rate	Positive BHCG blood test	12-14 days after the embryo transfer
Secondary	Clinical pregnancy rate	Ultrasound confirmation of an intrauterine gestational sac	At 6 week of gestation (4 weeks after embryo transfer)