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

NCT ID: NCT03974295

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2022-06-30

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).

Conditions

Infertility; Pregnancy Related; IVF

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intercourse Group

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

Group Type: EXPERIMENTAL

Vaginal unprotected intercourse

Intervention Type: 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.

Pelvic Rest Group

pelvic rest after frozen embryo transfer until positive pregnancy test

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: BACKGROUND

PMID: 23755954 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19590224 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11393126 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21300426 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17362946 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9436691 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7593509 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11464374 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29949304 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26178848 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14614040 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22706080 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9130761 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10632428 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10871650 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11098040 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25281684 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29755413 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24746744 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24045780 (View on PubMed)

Other Identifiers

Pro00040515

Identifier Type: -

Identifier Source: org_study_id