Intrauterine Injection of Human Chorionic Gonadotrophin and Pregnancy Rate in ICSI

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer on Implantation and Pregnancy Rates in Intracytoplasmic Sperm Injection: a Prospective Randomized Study

Conditions
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Repeated Implantation Failure

Intervention / Treatment
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* Drug: Human chorionic gonadotropin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human chorionic gonadotrophin<br>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<br>* intrauterine injected of 500 IU of hCG on the day of ovum pick-up and<br>* Other names: pregnyl;|
| No Intervention: control<br>The Control Group included 50 patients who went through the ICSI conventional protocol without intrauterine injection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | six weeks from the last menstrual period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | two weeks following embryo transfere | 
| 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. | eight weeks from last menstrual period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human chorionic gonadotropin