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InfertilityNCT03974295

The Impact of Vaginal Intercourse on Pregnancy Rates After Frozen Embryo Transfer

A study testing Vaginal unprotected intercourse in people with Infertility and Pregnancy Related, run by University of South Florida.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility, Pregnancy Related, IVF
What is being tested?
Vaginal unprotected intercourse
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
No sites listed yet
Study dates
1 Jul 2019to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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).

About this study

Official title: The Impact of Vaginal Intercourse on Pregnancy Rates After Frozen Embryo Transfer; A Single Blinded Randomized Trial.

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).

Read the 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).

Being tested
Vaginal unprotected intercourse
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vaginal unprotected intercourseBehavioural

    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.

Study groups in NCT03974295
Study groupRoleWhat they receive
Intercourse GroupExperimentalunlimited unprotected vaginal intercourse starting 24 hours after the frozen embryo transfer
Receives: Behavioral: Vaginal unprotected intercourse
Pelvic Rest GroupNo interventionpelvic rest after frozen embryo transfer until positive pregnancy test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 2 years

Secondary outcomes (5)

  1. 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.

    Measured: up to 2 years

  2. Clinical pregnancy rate

    Ongoing clinical pregnancy rate is defined as presence of a fetal heartbeat at 6-7 weeks of pregnancy.

    Measured: up to 2 years

  3. Biochemical pregnancy rate

    Biochemical pregnancy rate is defined as positive pregnancy test or elevated β-hCG level which does not result in implantation.

    Measured: up to 2 years

  4. Miscarriage rate

    Miscarriage rate is defined as a pregnancy loss is the loss of a fetus that occurs before 20 weeks of gestation.

    Measured: up to 2 years

  5. Live birth rate

    Live birth rate is defined as number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers.

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2019
  2. Study start1 Jul 2019 (estimated)
  3. Primary completion30 Jun 2021 (estimated)
  4. Study completion30 Jun 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03974295
Sponsor's protocol ID
Pro00040515
Status last verified
May 2019
First submitted
20 May 2019
Last updated
4 Jun 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Gaikwad S, Garrido N, Cobo A, Pellicer A, Remohi J. Bed rest after embryo transfer negatively affects in vitro fertilization: a randomized controlled clinical trial. Fertil Steril. 2013 Sep;100(3):729-35. doi: 10.1016/j.fertnstert.2013.05.011. Epub 2013 Jun 10.

    PubMed 23755954

  • Lambers MJ, Lambalk CB, Schats R, Hompes PG. Ultrasonographic evidence that bedrest after embryo transfer is useless. Gynecol Obstet Invest. 2009;68(2):122-6. doi: 10.1159/000226283. Epub 2009 Jul 3.

    PubMed 19590224

  • Su TJ, Chen YC, Hung YT, Yang YS. Comparative study of daily activities of pregnant and non-pregnant women after in vitro fertilization and embryo transfer. J Formos Med Assoc. 2001 Apr;100(4):262-8.

    PubMed 11393126

  • Li B, Zhou H, Li W. Bed rest after embryo transfer. Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):125-8. doi: 10.1016/j.ejogrb.2010.12.003.

    PubMed 21300426

  • Purcell KJ, Schembri M, Telles TL, Fujimoto VY, Cedars MI. Bed rest after embryo transfer: a randomized controlled trial. Fertil Steril. 2007 Jun;87(6):1322-6. doi: 10.1016/j.fertnstert.2006.11.060. Epub 2007 Mar 23.

    PubMed 17362946

  • Botta G, Grudzinskas G. Is a prolonged bed rest following embryo transfer useful? Hum Reprod. 1997 Nov;12(11):2489-92. doi: 10.1093/humrep/12.11.2489.

    PubMed 9436691

  • Sharif K, Afnan M, Lenton W, Khalaf Y, Ebbiary N, Bilalis D, Morgan C. Do patients need to remain in bed following embryo transfer? The Birmingham experience of 103 in-vitro fertilization cycles with no bed rest following embryo transfer. Hum Reprod. 1995 Jun;10(6):1427-9. doi: 10.1093/humrep/10.6.1427.

    PubMed 7593509

  • Rezabek K, Koryntova D, Zivny J. [Does bedrest after embryo transfer cause a worse outcome in in vitro fertilization?]. Ceska Gynekol. 2001 May;66(3):175-8. Czech.

    PubMed 11464374

  • Aoki Y, Kumakiri J, Itakura A, Kikuchi I, Takahashi N, Satoru T. Should sexual intercourse be avoided during the embryo transfer cycle? Life-threatening ruptured heterotopic pregnancy after single thawed embryo transfer: case report and review of the literature. Clin Exp Obstet Gynecol. 2017;44(3):489-491.

    PubMed 29949304

  • Schjenken JE, Robertson SA. Seminal Fluid Signalling in the Female Reproductive Tract: Implications for Reproductive Success and Offspring Health. Adv Exp Med Biol. 2015;868:127-58. doi: 10.1007/978-3-319-18881-2_6.

    PubMed 26178848

  • Gutsche S, von Wolff M, Strowitzki T, Thaler CJ. Seminal plasma induces mRNA expression of IL-1beta, IL-6 and LIF in endometrial epithelial cells in vitro. Mol Hum Reprod. 2003 Dec;9(12):785-91. doi: 10.1093/molehr/gag095.

    PubMed 14614040

  • Sharkey DJ, Macpherson AM, Tremellen KP, Mottershead DG, Gilchrist RB, Robertson SA. TGF-beta mediates proinflammatory seminal fluid signaling in human cervical epithelial cells. J Immunol. 2012 Jul 15;189(2):1024-35. doi: 10.4049/jimmunol.1200005. Epub 2012 Jun 15.

    PubMed 22706080

  • Laird SM, Tuckerman EM, Dalton CF, Dunphy BC, Li TC, Zhang X. The production of leukaemia inhibitory factor by human endometrium: presence in uterine flushings and production by cells in culture. Hum Reprod. 1997 Mar;12(3):569-74. doi: 10.1093/humrep/12.3.569.

    PubMed 9130761

  • Lim KJ, Odukoya OA, Ajjan RA, Li TC, Weetman AP, Cooke ID. The role of T-helper cytokines in human reproduction. Fertil Steril. 2000 Jan;73(1):136-42. doi: 10.1016/s0015-0282(99)00457-4.

    PubMed 10632428

  • von Wolff M, Thaler CJ, Strowitzki T, Broome J, Stolz W, Tabibzadeh S. Regulated expression of cytokines in human endometrium throughout the menstrual cycle: dysregulation in habitual abortion. Mol Hum Reprod. 2000 Jul;6(7):627-34. doi: 10.1093/molehr/6.7.627.

    PubMed 10871650

Questions about this trial

What is this clinical trial studying?

A study testing Vaginal unprotected intercourse in people with Infertility and Pregnancy Related, run by University of South Florida.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pregnancy rates (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03974295, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.

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