Injection of Hormone to Enhance Implantation in Embryo Transfer After IVF

Infertility Clinical Trial

Official title:

Intrauterine Injection of Human Chorionic Gonadotropin to Enhance Embryo Implantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01986374
• Other study ID #: HCG 2013
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: February 2016

Study information

• Verified date: November 2013
• Source: Servy Massey Fertility Insititute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The endometrium is deprived of signals form the embryo in IVF conditions. Studies suggest that placing HCG into the uterus prior to embryo transfer can enhance implantation.

Description:

The study is in pilot phase, uncontrolled. The risks appear to be minimal and there are conflicting new reports being announced.

A small amount of fluid with HCG is injected into the uterus. HCG is a potent signal to the uterus for preparation for implantation.

This is not a funded study. Three published studies suggest the approach is valid; one refutes the concept.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 47 Years

Eligibility

Inclusion Criteria:

• infertility patients undergoing IVF with good expectation of two embryos day 3 or day 5. must speak and read English. Includes donor eggs.

Exclusion Criteria:abnormal uterus

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Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• HCG is introduced
must have good blastocysts

Locations

Country	Name	City	State
United States	Servy Massey Fertility Insititute	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Servy Massey Fertility Insititute

Country where clinical trial is conducted

United States, 

References & Publications (4)

Hong KH, Forman EJ, Werner MD, Upham KM, Gumeny CL, Winslow AD, Kim TJ, Scott RT Jr. Endometrial infusion of human chorionic gonadotropin at the time of blastocyst embryo transfer does not impact clinical outcomes: a randomized, double-blind, placebo-controlled trial. Fertil Steril. 2014 Dec;102(6):1591-5.e2. doi: 10.1016/j.fertnstert.2014.08.006. Epub 2014 Sep 16. — View Citation

Mansour R, Tawab N, Kamal O, El-Faissal Y, Serour A, Aboulghar M, Serour G. Intrauterine injection of human chorionic gonadotropin before embryo transfer significantly improves the implantation and pregnancy rates in in vitro fertilization/intracytoplasmic sperm injection: a prospective randomized study. Fertil Steril. 2011 Dec;96(6):1370-1374.e1. doi: 10.1016/j.fertnstert.2011.09.044. Epub 2011 Nov 1. — View Citation

Santibañez A, García J, Pashkova O, Colín O, Castellanos G, Sánchez AP, De la Jara JF. Effect of intrauterine injection of human chorionic gonadotropin before embryo transfer on clinical pregnancy rates from in vitro fertilisation cycles: a prospective study. Reprod Biol Endocrinol. 2014 Jan 29;12:9. doi: 10.1186/1477-7827-12-9. — View Citation

Zarei A, Parsanezhad ME, Younesi M, Alborzi S, Zolghadri J, Samsami A, Amooee S, Aramesh S. Intrauterine administration of recombinant human chorionic gonadotropin before embryo transfer on outcome of in vitro fertilization/ intracytoplasmic sperm injection: A randomized clinical trial. Iran J Reprod Med. 2014 Jan;12(1):1-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCG enhances pregnancy rate	compare pregnancy rates to established clinical norms.	9 months.
Secondary	implantation rate	compare implantation rate per embryo to clinical norms.	18 months
Secondary	ongoing pregnancy rate	compare success to clinical norms	22 months