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Intrauterine Injection of Human Chorionic Gonadotrophin and Pregnancy Rate in ICSI

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ClinicalTrials.gov Identifier: NCT03445910
Recruitment Status : Completed
First Posted : February 26, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Hayam Fathy Mohammad, Ain Shams University

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.


Condition or disease Intervention/treatment Phase
Repeated Implantation Failure Drug: Human chorionic gonadotropin Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: one hundred opaque envelopes will be numbered serially and in each envelope the corresponding letter which denotes the allocated group will be put according to randomization table. Then all envelopes will be closed and put in one box. When the first patient arrives, the first envelope will be opened and the patient will be allocated according to the letter inside.
Primary Purpose: Treatment
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
Actual Study Start Date : February 20, 2018
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
intrauterine injected of 500 IU of hCG on the day of ovum pick-up and
Other Names:
  • Chorimone
  • pregnyl

No Intervention: control
The Control Group included 50 patients who went through the ICSI conventional protocol without intrauterine injection.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03445910


Locations
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Egypt
Ain Shams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Hayam F Mohammad, MD Ain Shams University

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Responsible Party: Hayam Fathy Mohammad, Assisted professor of obstetrics and gynecology, Ain Shams University
ClinicalTrials.gov Identifier: NCT03445910     History of Changes
Other Study ID Numbers: 3
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hayam Fathy Mohammad, Ain Shams University:
human chorionic gonadotropin
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs