The role of seminal plasma for improved outcomes during in vitro fertilization treatment: review of the literature and meta-analysis.
Giselle Crawford, Arpita Ray, Anil Gudi...
https://pubmed.ncbi.nlm.nih.gov/25281684Actively Recruiting
Phase Not Applicable
Age: 18Years - 41Years
FEMALE
Healthy Volunteers
ID06134609
Does Sexual Intercourse Affect the Outcomes of Frozen-thawed Embryo Transfer? Randomized Controlled Trial
Led by Sheba Medical Center · Updated on 2023-11-18
656
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether sexual intercourse the night after a frozen embryo transfer affects the chances of the embryo implanting successfully. This clinical trial involves women aged 18 to 41 undergoing one of their first four frozen embryo transfers with a good quality embryo. The study aims to compare ongoing pregnancy rates between women who have intercourse the night after embryo transfer and those who abstain for 48 hours. Participants will be randomly assigned to one of two groups. One group will have intercourse without using a condom the evening or night after the embryo transfer, while the other group will abstain from intercourse for the next 48 hours. On the day after the transfer, participants will receive an electronic questionnaire to confirm intercourse and related details. Blood tests for pregnancy hormone levels will be done 12 to 14 days after transfer, followed by an ultrasound at 6 weeks for those with positive tests. Throughout the study, researchers will monitor pregnancy outcomes through hormone tests and ultrasound scans to evaluate embryo implantation success. The study ends after the 6-week ultrasound, with no further follow-up required. Participants will provide information via questionnaires and undergo blood testing and ultrasound exams as part of the assessments. The total duration of involvement is about six weeks from embryo transfer.
CONDITIONS
Brief Title
Does Sexual Intercourse Affect the Outcomes of Frozen-thawed Embryo Transfer?
Who Can Participate
Age: 18Years - 41Years
FEMALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Women age 18 to 41 years
- Body mass index (BMI) between 18 and 35 kg/m²
- Undergoing one of their first four frozen embryo transfers
- Transferring a good quality embryo, either a cleavage stage embryo or a day 5 blastocyst
You will not qualify if you...
- Age above 42 years
- Moderate or poor-quality embryos
- Presence of hydrosalpinx or uterus malformations
- Unable or unwilling to have vaginal intercourse (including same sex couples)
- Couples undergoing preimplantation genetic diagnosis when natural cycle frozen embryo transfer is planned
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 1 day
Participants undergo a frozen embryo transfer and are assigned either to have sexual intercourse the night after the transfer or to abstain from intercourse for 48 hours.
1 visit (in-person) on the day of embryo transfer
Surveillance
Duration - Up to 6 weeks
Participants receive a serum BHCG test 12 to 14 days after embryo transfer to assess biochemical pregnancy. Those with a positive test undergo a gynecologic ultrasound at 6 weeks of gestation. Surveillance ends after the ultrasound.
1 visit for BHCG test and 1 visit for ultrasound if BHCG is positive
Trial Site Locations
Total: 1 location
1
Sheba Medical Center
Ramat Gan, Israel
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
Seminal fluid and fertility in women.
Sarah A Robertson, David J Sharkey
https://pubmed.ncbi.nlm.nih.gov/27485480Uterine contractions at the time of embryo transfer alter pregnancy rates after in-vitro fertilization.
R Fanchin, C Righini, F Olivennes...
https://pubmed.ncbi.nlm.nih.gov/9740459Effectiveness of seminal plasma in in vitro fertilisation treatment: a systematic review and meta-analysis.
G Saccone, A Di Spiezio Sardo, A Ciardulli...
https://pubmed.ncbi.nlm.nih.gov/29078039Impact of sexual intercourse on frozen-thawed embryo transfer outcomes: a randomized controlled trial.
Jin-Wei Hou, Li-Hua Yuan, Xian-Ling Cao...
https://pubmed.ncbi.nlm.nih.gov/36859338