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

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.

Study Overview

• Status: Recruiting
• Conditions: Embryo Transfer; Fertilization in Vitro; Coitus
• Intervention / Treatment: Behavioral: Sexual intercourse

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 Type: Interventional
• Enrollment (Estimated): 656
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Recruiting
    • Sheba Medical Center
    • Contact: Dror Dr., MD; Phone Number: 97235305000; Email: dror.lifshitz@sheba.health.gov.il
    • Principal Investigator: Dror Lifshitz, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Assigned to intercourse; The study group is subjected to perform intercourse without using a condom at the evening/night after the embryo transfer	Behavioral: Sexual intercourse; Sexual intercourse without barrier contraceptive at the evening/night after the embryo transfer
No Intervention: Assigned to abstain; The control group is assigned to abstain from coitus the next 48 hours after the embryo transfer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing pregnancy rate	Ultrasound showing a fetus with a heartbeat	At 6 week of gestation (4 weeks after embryo transfer)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemical pregnancy rate	Positive BHCG blood test	12-14 days after the embryo transfer
Clinical pregnancy rate	Ultrasound confirmation of an intrauterine gestational sac	At 6 week of gestation (4 weeks after embryo transfer)

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 12, 2023
• First Submitted That Met QC Criteria: November 12, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 20, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: IVF; Pregnancy; Sexual intercourse; Embryo Transfer; Coitus
• Other Study ID Numbers: SMC-0653-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No