The Impact of Vaginal Intercourse on Pregnancy Rates After Frozen Embryo Transfer
Primary Purpose
Infertility, Pregnancy Related, IVF
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vaginal unprotected intercourse
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- female fertility patients having frozen embryo transfer
- programmed hormone replacement (Oral Estrace, Vivelle dot (patch), intravenous Estradiol) with and without gonadotrophin releasing hormone analogue pretreatment and some form of parenteral progesterone supplementation (daily or every 3 days intramuscular Progesterone) for luteal support
Exclusion Criteria:
- unable to provide informed consent
- not undergoing programmed hormone replacement for frozen embryo transfer (natural cycle frozen embryo transfer)
- undergoing fresh embryo transfer
- not able to engage in heterosexual intercourse (same sex couple, partner with severe sexual dysfunction)
- cannot undergo unprotected vaginal intercourse (infected with hepatitis B, C, or human immunodeficiency virus).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intercourse Group
Pelvic Rest Group
Arm Description
unlimited unprotected vaginal intercourse starting 24 hours after the frozen embryo transfer
pelvic rest after frozen embryo transfer until positive pregnancy test
Outcomes
Primary Outcome Measures
Pregnancy rates
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.
Secondary Outcome Measures
Implantation rates
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
Ongoing clinical pregnancy rate is defined as presence of a fetal heartbeat at 6-7 weeks of pregnancy.
Biochemical pregnancy rate
Biochemical pregnancy rate is defined as positive pregnancy test or elevated β-hCG level which does not result in implantation.
Miscarriage rate
Miscarriage rate is defined as a pregnancy loss is the loss of a fetus that occurs before 20 weeks of gestation.
Live birth rate
Live birth rate is defined as number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03974295
Brief Title
The Impact of Vaginal Intercourse on Pregnancy Rates After Frozen Embryo Transfer
Official Title
The Impact of Vaginal Intercourse on Pregnancy Rates After Frozen Embryo Transfer; A Single Blinded Randomized Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Pregnancy Related, IVF
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intercourse Group
Arm Type
Experimental
Arm Description
unlimited unprotected vaginal intercourse starting 24 hours after the frozen embryo transfer
Arm Title
Pelvic Rest Group
Arm Type
No Intervention
Arm Description
pelvic rest after frozen embryo transfer until positive pregnancy test
Intervention Type
Behavioral
Intervention Name(s)
Vaginal unprotected intercourse
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pregnancy rates
Description
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.
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Implantation rates
Description
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.
Time Frame
up to 2 years
Title
Clinical pregnancy rate
Description
Ongoing clinical pregnancy rate is defined as presence of a fetal heartbeat at 6-7 weeks of pregnancy.
Time Frame
up to 2 years
Title
Biochemical pregnancy rate
Description
Biochemical pregnancy rate is defined as positive pregnancy test or elevated β-hCG level which does not result in implantation.
Time Frame
up to 2 years
Title
Miscarriage rate
Description
Miscarriage rate is defined as a pregnancy loss is the loss of a fetus that occurs before 20 weeks of gestation.
Time Frame
up to 2 years
Title
Live birth rate
Description
Live birth rate is defined as number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers.
Time Frame
up to 2 years
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only patients undergoing embryo transfer will be candidates for the study.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
female fertility patients having frozen embryo transfer
programmed hormone replacement (Oral Estrace, Vivelle dot (patch), intravenous Estradiol) with and without gonadotrophin releasing hormone analogue pretreatment and some form of parenteral progesterone supplementation (daily or every 3 days intramuscular Progesterone) for luteal support
Exclusion Criteria:
unable to provide informed consent
not undergoing programmed hormone replacement for frozen embryo transfer (natural cycle frozen embryo transfer)
undergoing fresh embryo transfer
not able to engage in heterosexual intercourse (same sex couple, partner with severe sexual dysfunction)
cannot undergo unprotected vaginal intercourse (infected with hepatitis B, C, or human immunodeficiency virus).
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
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23755954
Citation
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The Impact of Vaginal Intercourse on Pregnancy Rates After Frozen Embryo Transfer
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