Ignite Creation Date:
2024-05-06 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06134609
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-11-12
Brief Title:
Does Sexual Intercourse Affect the Outcomes of Frozen-thawed Embryo Transfer
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
Does Sexual Intercourse Affect the Outcomes of Frozen-thawed Embryo Transfer Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eveningnight 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
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 eveningnight 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
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 eveningnight 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None