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NCT Number: NCT03445910

Intrauterine Injection of Human Chorionic Gonadotrophin and Pregnancy Rate in ICSI

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.

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Key information

Conditions

Repeated Implantation Failure

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Human Chorionic Gonadotropin

Drug

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

Other names: Chorimone, pregnyl

Primary outcomes

  1. implantation rate

    Time frame: six weeks from the last menstrual period

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

Secondary outcomes

  1. biochemical pregnancy

    Time frame: two weeks following embryo transfere

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

  2. clinical pregnancy

    Time frame: eight weeks from last menstrual period

    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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2018
Registry last updated
Aug 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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