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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03974295
• Other study ID #: Pro00040515
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2019
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Infertility
• IVF
• Pregnancy Related

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

References & Publications (20)

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. Review. — View Citation

Botta G, Grudzinskas G. Is a prolonged bed rest following embryo transfer useful? Hum Reprod. 1997 Nov;12(11):2489-92. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Mar 23. — View Citation

Rezábek K, Koryntová D, Zivný J. [Does bedrest after embryo transfer cause a worse outcome in in vitro fertilization?]. Ceska Gynekol. 2001 May;66(3):175-8. Czech. — View Citation

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. Review. — View Citation

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. — View Citation

Sharkey DJ, Macpherson AM, Tremellen KP, Mottershead DG, Gilchrist RB, Robertson SA. TGF-ß 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. — View Citation

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. — View Citation

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. — View Citation

Tremellen KP, Valbuena D, Landeras J, Ballesteros A, Martinez J, Mendoza S, Norman RJ, Robertson SA, Simón C. The effect of intercourse on pregnancy rates during assisted human reproduction. Hum Reprod. 2000 Dec;15(12):2653-8. — View Citation

von Wolff M, Rösner 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. — View Citation

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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	up to 2 years
Secondary	Clinical pregnancy rate	Ongoing clinical pregnancy rate is defined as presence of a fetal heartbeat at 6-7 weeks of pregnancy.	up to 2 years
Secondary	Biochemical pregnancy rate	Biochemical pregnancy rate is defined as positive pregnancy test or elevated ß-hCG level which does not result in implantation.	up to 2 years
Secondary	Miscarriage rate	Miscarriage rate is defined as a pregnancy loss is the loss of a fetus that occurs before 20 weeks of gestation.	up to 2 years
Secondary	Live birth rate	Live birth rate is defined as number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers.	up to 2 years