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

NCT06134609 | Recruiting

• 1 other identifier: SMC-0653-23
• Study Type: interventional
• Target: 656
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Embryo Transfer; Fertilization in Vitro; Coitus

Keywords

IVF; Embryo Transfer; Sexual intercourse; Coitus; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  Ultrasound showing a fetus with a heartbeat

  At 6 week of gestation (4 weeks after embryo transfer)

Secondary Outcomes (2)

• Biochemical pregnancy rate

  12-14 days after the embryo transfer

• Clinical pregnancy rate

  At 6 week of gestation (4 weeks after embryo transfer)

Study Arms (2)

Assigned to intercourse

EXPERIMENTAL

The study group is subjected to perform intercourse without using a condom at the evening/night after the embryo transfer

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.

Interventions

Sexual intercourse BEHAVIORAL

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

Assigned to intercourse

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Related 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.

  PMID: 25281684 BACKGROUND

• 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.

  PMID: 27485480 BACKGROUND

• 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.

  PMID: 9740459 BACKGROUND

• 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.

  PMID: 29078039 BACKGROUND

• 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.

  PMID: 36859338 BACKGROUND

MeSH Terms

Conditions

Coitus

Interventions

Sex

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: November 18, 2023
• Study Start: November 13, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)