Clinical trial NCT03445910: Intrauterine Injection of Human Chorionic Gonadotrophin and Pregnancy Rate in ICSI
Official title: Effect of Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer on Implantation and Pregnancy Rates in Intracytoplasmic Sperm Injection: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Repeated Implantation Failure
Keywords: human chorionic gonadotropin
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Despite recent advances in clinical and laboratory techniques of Assisted Reproductive Technology (ART), the pregnancy rate remains around 30% per cycle. It has been estimated that 50% to 75% of lost pregnancies are due to failure of implantation.

The process of implantation is a locally controlled paracrine/juxtacrine-mediated phenomenon. Successful implantation depends on the synchronized "cross-talk" between a functional blastocyst and a "receptive" endometrium. This process leads to apposition, attachment and invasion of embryos and subsequent normal placentation. So the objective of this study is investigate the impact of intrauterine injection of human chorionic gonadotropin (hCG) at the day of ovum pick-up on implantation and pregnancy rates in patients with recurrent implantation failure.

Detailed description: The endometrium can only support implantation during a discrete period of about 6 to 9 days after LH peak; termed the "window of implantation". During this period endometrial glandular epithelium is differentiated into a highly secretory state with the production of various cytokines and growth factors that facilitate implantation. In fact, several substances secreted from the embryo or the endometrium affect implantation. These include cyclic adenosine monophosphate, relaxin, gonadotropin, prostaglandin E2, and glycoprotein hormones.

Human chorionic gonadotropin (hCG) is the earliest blastocyst-derived signals received by the endometrium; it is transcribed as early as the 2-cell embryo stage. It is produced by the trophectodermal cells of the preimplantation blastocyst. Recent evidence suggests that hCG is also produced by the endometrial epithelial cells during the secretory.

It has been shown that intrauterine injection of hCG before embryo transfer significantly improves pregnancy rates in IVF/ICSI cycles.

Eligibility criteria: Inclusion Criteria:

A- Age between 20 and 35 years old.

B- Patients undergoing ICSI trial after one or more previous failure.

Exclusion Criteria:

A- Females with any local cause, uterine pathology, e.g: uterine myoma or previous myomectomy, endometriosis or the presence of hydrosalpinges.

B- Patients undergoing ICSI trial for the first time.

C- Previous Asherman Syndrome.

Primary outcomes:
measure: implantation rate
timeFrame: six weeks from the last menstrual period
Secondary outcomes:
measure: biochemical pregnancy
timeFrame: two weeks following embryo transfere
measure: clinical pregnancy
timeFrame: eight weeks from last menstrual period
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Hayam F Mohammad, MD
role: PRINCIPAL_INVESTIGATOR
References: