The Impact of Vaginal Intercourse on Pregnancy Rates After Frozen Embryo Transfer
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|ClinicalTrials.gov Identifier: NCT03974295|
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Infertility Pregnancy Related IVF||Behavioral: Vaginal unprotected intercourse||Not Applicable|
Given the overwhelming evidence suggesting beneficial effect of seminal plasma on embryo implantation, we sought to explore this benefits in in vitro fertilization treatments by limiting the study cohort to those having frozen embryo transfer with programmed hormone replacement for endometrial preparation and some form of parenteral progesterone supplementation. This design will enable us to overcome the concerns and limitations of all previous studies. In this study, patients will be randomized into two groups, group 1 will have their frozen embryo transfer followed by current standard of care (no unprotected vaginal intercourse until pregnancy test) and group 2 will have their frozen embryo transfer followed by unlimited unprotected vaginal intercourse starting 24 hours after transfer. The primary endpoint of the study will be ongoing clinical pregnancy
rates in the two groups while secondary endpoints will include implantation, positive pregnancy, miscarriage and live birth rates. Overall, this study aims to investigate whether the elimination of current universal pelvic rest protocol in patients undergoing frozen embryo transfer will help optimize pregnancy outcomes.
This study aims to evaluate whether allowing unprotected vaginal intercourse 24 hours after frozen embryo transfer will result in higher ongoing clinical pregnancy rates in comparison to having participants abstain from unprotected vaginal intercourse until pregnancy test (10-14 days after frozen embryo transfer).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||After informed consent signing and randomization using a computer generated randomization scheme, the Research Nurse will open a numbered, opaque, and sealed envelope, within which there will be a white sheet of paper labelled with the patient assigned group. The participant will be informed of their assigned group by the Research Nurse. Patients assigned to the study group will be handed a log to record the number of times the patient engages in unprotected vaginal intercourse. The fertility providers will be blinded to the patients assigned treatment group. Patients who do not consent to be part of the study will still undergo their planned frozen embryo transfer per protocol.|
|Official Title:||The Impact of Vaginal Intercourse on Pregnancy Rates After Frozen Embryo Transfer; A Single Blinded Randomized Trial.|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: Intercourse Group
unlimited unprotected vaginal intercourse starting 24 hours after the frozen embryo transfer
Behavioral: Vaginal unprotected intercourse
Patients will allowed to engage in vaginal unprotected intercourse as many times as desired after 24 hours of pelvic rest after a frozen embryo transfer.
No Intervention: Pelvic Rest Group
pelvic rest after frozen embryo transfer until positive pregnancy test
- Pregnancy rates [ Time Frame: up to 2 years ]A serum quantitative pregnancy test will be performed 10-14 days following the frozen embryo transfer per clinic protocol. Positive pregnancy test is defined a serum quantitative beta hCG > 5 mU/mL.
- Implantation rates [ Time Frame: up to 2 years ]Implantation rate will be defined as number of gestational sacs observed at echographic screening at 6 weeks of pregnancy divided by the number of embryos transferred.
- Clinical pregnancy rate [ Time Frame: up to 2 years ]Ongoing clinical pregnancy rate is defined as presence of a fetal heartbeat at 6-7 weeks of pregnancy.
- Biochemical pregnancy rate [ Time Frame: up to 2 years ]Biochemical pregnancy rate is defined as positive pregnancy test or elevated β-hCG level which does not result in implantation.
- Miscarriage rate [ Time Frame: up to 2 years ]Miscarriage rate is defined as a pregnancy loss is the loss of a fetus that occurs before 20 weeks of gestation.
- Live birth rate [ Time Frame: up to 2 years ]Live birth rate is defined as number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers.