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

NCT03974295 | Unknown

• 1 other identifier: Pro00040515
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Infertility; Pregnancy Related; IVF

Outcome Measures

Primary Outcomes (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.

  up to 2 years

Secondary Outcomes (5)

• Implantation rates

  up to 2 years

• Clinical pregnancy rate

  up to 2 years

• Biochemical pregnancy rate

  up to 2 years

• Miscarriage rate

  up to 2 years

• Live birth rate

  up to 2 years

Study Arms (2)

Intercourse Group

EXPERIMENTAL

unlimited unprotected vaginal intercourse starting 24 hours after the frozen embryo transfer

Behavioral: Vaginal unprotected intercourse

Pelvic Rest Group

NO INTERVENTION

pelvic rest after frozen embryo transfer until positive pregnancy test

Interventions

Vaginal unprotected intercourse BEHAVIORAL

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.

Intercourse Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Only patients undergoing embryo transfer will be candidates for the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of South Florida: lead

Related Publications (20)

• 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.

  PMID: 23755954 BACKGROUND

• 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.

  PMID: 19590224 BACKGROUND

• 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.

  PMID: 11393126 BACKGROUND

• 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.

  PMID: 21300426 BACKGROUND

• 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.

  PMID: 17362946 BACKGROUND

• 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.

  PMID: 9436691 BACKGROUND

• 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.

  PMID: 7593509 BACKGROUND

• 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.

  PMID: 11464374 BACKGROUND

• 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.

  PMID: 29949304 BACKGROUND

• 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.

  PMID: 26178848 BACKGROUND

• 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.

  PMID: 14614040 BACKGROUND

• 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.

  PMID: 22706080 BACKGROUND

• 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.

  PMID: 9130761 BACKGROUND

• 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.

  PMID: 10632428 BACKGROUND

• 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.

  PMID: 10871650 BACKGROUND

• Tremellen KP, Valbuena D, Landeras J, Ballesteros A, Martinez J, Mendoza S, Norman RJ, Robertson SA, Simon C. The effect of intercourse on pregnancy rates during assisted human reproduction. Hum Reprod. 2000 Dec;15(12):2653-8. doi: 10.1093/humrep/15.12.2653.

  PMID: 11098040 BACKGROUND

• Crawford G, Ray A, Gudi A, Shah A, Homburg R. The role of seminal plasma for improved outcomes during in vitro fertilization treatment: review of the literature and meta-analysis. Hum Reprod Update. 2015 Mar-Apr;21(2):275-84. doi: 10.1093/humupd/dmu052. Epub 2014 Oct 3.

  PMID: 25281684 BACKGROUND

• Nawroth F, von Wolff M. Seminal Plasma Activity to Improve Implantation in In Vitro Fertilization-How Can It Be Used in Daily Practice? Front Endocrinol (Lausanne). 2018 Apr 27;9:208. doi: 10.3389/fendo.2018.00208. eCollection 2018. No abstract available.

  PMID: 29755413 BACKGROUND

• Steiner AZ, Pritchard DA, Young SL, Herring AH. Peri-implantation intercourse lowers fecundability. Fertil Steril. 2014 Jul;102(1):178-82. doi: 10.1016/j.fertnstert.2014.03.017. Epub 2014 Apr 18.

  PMID: 24746744 BACKGROUND

• von Wolff M, Rosner S, Germeyer A, Jauckus J, Griesinger G, Strowitzki T. Intrauterine instillation of diluted seminal plasma at oocyte pick-up does not increase the IVF pregnancy rate: a double-blind, placebo controlled, randomized study. Hum Reprod. 2013 Dec;28(12):3247-52. doi: 10.1093/humrep/det351. Epub 2013 Sep 17.

  PMID: 24045780 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: June 4, 2019
• Study Start: July 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2022
• Last Updated: June 4, 2019

Record last verified: 2019-05