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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
Sponsor:
Information provided by (Responsible Party):
University of South Florida

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).

Condition or disease Intervention/treatment Phase
Infertility Pregnancy Related IVF Behavioral: Vaginal unprotected intercourse Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only patients undergoing embryo transfer will be candidates for the study.
Accepts Healthy Volunteers:   Yes
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).

Publications:

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03974295     History of Changes
Other Study ID Numbers: Pro00040515
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female