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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-41
SponsorSheba Medical Center

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sexual intercourse

    Behavioral

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

Treatment groups

656 Participants
are divided into 2 treatment groups
Group A: Assigned to intercourseExperimental treatment 1 intervention
Group B: Assigned to abstainNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Ongoing pregnancy rate

Ultrasound showing a fetus with a heartbeat

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

Secondary outcomes

1

Biochemical pregnancy rate

Positive BHCG blood test

Time frame
12-14 days after the embryo transfer
2

Clinical pregnancy rate

Ultrasound confirmation of an intrauterine gestational sac

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

Other outcomes

Sponsors and contacts

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