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NCT Number: NCT06134609

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

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.

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Key information

Age range

18 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sheba Medical Center

Ramat Gan, Israel

Location status: Recruiting

Location contact

Dror Dr., MD

CONTACT

[email protected]

97235305000

Dror Lifshitz, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Sexual intercourse

Behavioral

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

Primary outcomes

  1. Ongoing pregnancy rate

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

    Ultrasound showing a fetus with a heartbeat

Secondary outcomes

  1. Biochemical pregnancy rate

    Time frame: 12-14 days after the embryo transfer

    Positive BHCG blood test

  2. Clinical pregnancy rate

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

    Ultrasound confirmation of an intrauterine gestational sac

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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