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CompletedNCT03445910Updated Aug 14, 2018

Intrauterine Injection of Human Chorionic Gonadotrophin and Pregnancy Rate in ICSI

An interventional study of Human chorionic gonadotropin in Repeated Implantation Failure, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-08-14.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Repeated Implantation Failure

Keywords

  • human chorionic gonadotropin
03

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

A- Age between 20 and 35 years old.

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

Exclusion criteria

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.

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Human chorionic gonadotrophin

    The hCG Group included 50 patients who had an intrauterine injected of 500 IU of hCG on the day of ovum pick-up

    Drug: Human chorionic gonadotropin

  • No intervention
    control

    The Control Group included 50 patients who went through the ICSI conventional protocol without intrauterine injection.

Interventions

  • DrugHuman chorionic gonadotropin

    intrauterine injected of 500 IU of hCG on the day of ovum pick-up and

    Also known as: Chorimone, pregnyl

05

What researchers measure

Primary outcomes

  1. implantation rate

    is defined as the number of gestational sacs observed at echographic screening at 6 weeks of pregnancy divided by the number of embryos transferred

    Time frame: six weeks from the last menstrual period

Secondary outcomes

  1. biochemical pregnancy

    defined as positive from quantitative values of serum test of β human chorionic gonadotropin according to standard values that are used in the laboratory.

    Time frame: two weeks following embryo transfere

  2. clinical pregnancy

    is defined as viable pregnancy when there is evidence of gestational sac, embryo and fetal heart activity at time of trans-vaginal ultrasound evaluation by the 8th week.

    Time frame: eight weeks from last menstrual period

06

Study locations

1 site
  • Ain Shams University
    Cairo, Egypt
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03445910
Lead sponsor
Ain Shams University
Responsible party
Hayam Fathy Mohammad (Assisted professor of obstetrics and gynecology, Ain Shams University) — Principal investigator
First posted
Feb 26, 2018
Start date
Feb 20, 2018
Primary completion
Jun 1, 2018
Completion
Jul 30, 2018
Last update
Aug 14, 2018

Study contacts

Hayam F Mohammad, MD
principal investigator · Ain Shams University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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