Clinical trial NCT01986374: Injection of Hormone to Enhance Implantation in Embryo Transfer After IVF
Official title: Intrauterine Injection of Human Chorionic Gonadotropin to Enhance Embryo Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: IVF , embryo implantation, HCG
Lead sponsor: Servy Massey Fertility Insititute
Sponsor class: OTHER
First posted: 2013-11-18
Enrollment: 75
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

-

Primary outcomes:
measure: HCG enhances pregnancy rate
timeFrame: 9 months.
Secondary outcomes:
measure: implantation rate
timeFrame: 18 months
measure: ongoing pregnancy rate
timeFrame: 22 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Servy Massey Fertility Insititute
state: Georgia
Study officials:
affiliation: Servy Massey Fertilty Institute
name: Joe B Massey, MD
role: STUDY_CHAIR
References:
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.
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.
citation: Santibanez A, Garcia J, Pashkova O, Colin O, Castellanos G, Sanchez 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.
citation: 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.