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Effect of Intrauterine Injection of Hcg Before ET on Clinical Outcomes in IVF/ICSI Cycles

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ClinicalTrials.gov Identifier: NCT03238807
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Karim Abdallah, Assiut University

Brief Summary:

Subfertility is the inability to conceive after 12 months of regular unprotected sexual intercourse. Around 15% of couples suffer from subfertility. As a treatment for subfertility, Assisted Reproductive Techniques (ART) have been a choice for subfertile couples. In Egypt in 2010, Pregnancy Rate was calculated to be 36.2%, Live Birth Rate to be 25.7%.

Implantation is the process by which the embryo adheres to the wall of the uterus. Endometrial receptivity plays the most important role for successful implantation after embryo quality. It is estimated that up to 70% of early pregnancy losses are due to failure of implantation.

Despite extensive research, the embryo-maternal dialogue that orchestrates the implantation process is still not fully understood. Much effort has been done in the last decades to detect factors affecting Implantation and improve endometrial receptivity.

Human Chorionic Gonadotropin (hCG) is a placental glycoprotein hormone that required to maintain pregnancy. Recent research data demonstrates that hCG is secreted very early by the embryo before implantation to facilitate it. hCG has been proved to cause attraction of inflammatory cells, promote angiogenesis, regulate chemical mediators at the endometrium. These effects proceed the classical role of hCG during pregnancy and could be a directly involved in and facilitating the implantation process.

Studies have been conducted to study the effect of injection of different concentrations of hCG inside the uterine cavity before Embryo Transfer (ET) to improve endometrial receptivity and outcomes of In-Vitro Fertilization (IVF) or Intra-Cytoplasmic Sperm Injection (ICSI) cycles.

A recent systematic review was conducted on 12 studies performing intrauterine injection of different doses of hCG before ET. Results of this study showed that there is increased pregnancy outcome after injection of intrauterine 500 IU of hCG. The study recommended a definitive large clinical trial with live birth as the primary outcome. There was no evidence that miscarriage was influenced by intrauterine hCG administration, irrespective of embryo stage at transfer or dose of intrauterine hCG.

Aim of the study:

To detect whether intrauterine injection of hCG before ET improves clinical outcomes in IVF/ICSI cycles.


Condition or disease Intervention/treatment Phase
Infertility ART Drug: Human Chorionic Gonadotropin Not Applicable

Detailed Description:

This study is a Randomized Controlled Trial (RCT) to be done at ART center of Women's Health Hospital, Assiut university, Egypt.

All steps for IVF/ICSI procedure, from the beginning of the induction for controlled ovarian stimulation until just before the procedure of ET, will be done for all enrolled patients as routinely decided according to the local protocol of the ART center in Women Health Hospital, Assiut University. In the day of ET, number and quality of Embryos will be decided according to the routine practice guided by the local protocol.

The intervention preparation will be prepared by adding one vial of hCG containing 5000 IU to 1mL of tissue culture medium (Continuous Single Culture, IrvineScientific). To obtain 500 IU of hCG, 0.1 milliLiter (mL) of the preparation will be injected inside the uterus before ET in the study group. For the control group, 0.1 mL of the tissue culture medium without hCG will be injected inside the uterus before the ET. For both groups we will use Intra-Uterine Insemination (IUI) catheter (Sperm Trans, Sperm Processor) to inject the solution inside the uterine cavity 4 minutes before ET.

We will standardize the procedure of ET for all women apart from the intervention versus control step. All women participating in the study will be put in lithotomy position. Cusco's speculum will be introduced to visualize the cervix. Guided by transabdominal ultrasound with a full bladder, the ET catheter (Cook Sydney IVF Catheter) will be introduced through the cervical os into the uterine cavity. After introduction of the catheter into the uterine cavity loaded embryos will be injected inside the cavity 0.5 cm from the fundus.

Biochemical pregnancy test will be done 14 days after ET by measuring hCG in the woman's serum. If the test result is positive (according to the standard values that is used in the laboratory), a transvaginal ultrasound will be done 3 weeks following the positive biochemical test, to document the visualization of gestational sac, fetal pole and cardiac pulsation.

Pregnancy rate (PR) is calculated by the number of women with positive biochemical pregnancy test to the number of women enrolled in each group. The clinical pregnancy was defined as a viable pregnancy when there is evidence of a gestational sac, embryo and fetal heart rate at the time of ultrasound evaluation. Clinical Pregnancy Rate (cPR) is calculated by the percentage of detected clinical pregnancies using ultrasound to the IVF/ICSI cycles in each group. Implantation rate (IR) is calculated by the number of visualized embryos by transvaginal ultrasound to the number of transferred embryos. While Live Birth Rate (LBR) is calculated by the number of live births to the number of transferred embryos. Miscarriage rate (MR) is calculated by the ratio of miscarriages to the number of confirmed pregnancies.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Double (Participant, Care Provider)
Masking Description: Double-Blinded
Primary Purpose: Prevention
Official Title: Effect of Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer on Clinical Outcomes in In-vitro Fertilization/Intracytoplasmic Sperm Injection Cycles: a Randomized Controlled Trial
Actual Study Start Date : July 8, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention Group
Group that will receive intrauterine injection of human Chorionic Gonadotropin before ET
Drug: Human Chorionic Gonadotropin
500 IU of human Chorionic Gonadotropin
Other Name: Epifasi

No Intervention: Control Group
Control Group



Primary Outcome Measures :
  1. Clinical Pregnancy Rate (cPR) [ Time Frame: 5 weeks ]
    calculated by the percentage of detected clinical pregnancies using ultrasound to the IVF/ICSI cycles in each group


Secondary Outcome Measures :
  1. Implantation Rate (IR) [ Time Frame: 5 weeks ]
    calculated by the number of visualized embryos by transvaginal ultrasound to the number of transferred embryos

  2. Live Birth Rate (LBR) [ Time Frame: 9 months ]
    calculated by the number of live births to the number of transferred embryos

  3. Miscarriage rate (MR) [ Time Frame: 3 months ]
    calculated by the ratio of miscarriages to the number of confirmed pregnancies.



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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infertility, male or female factor
  • Women undergoing ICSI/IVF

Exclusion Criteria:

  • functional azoospermia
  • submucous uterine myomas or previous myomectomy
  • endometriosis
  • hydrosalpinges without prior excision or occlusion of the tubal ostia

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): NCT03238807


Contacts
Contact: Karim Abdallah, M.Sc +201000024188 karimsayed88@hotmail.com

Locations
Egypt
Assiut University - Women's Health Hospital Recruiting
Assiut, Egypt, 71515
Contact: Karim Abdallah, M.Sc    +201000024188    karimsayed88@hotmail.com   
Sponsors and Collaborators
Assiut University
Investigators
Principal Investigator: Ahmed Makhlouf, MD Assiut University
Study Chair: Hazem Saadeldine, MD Assiut University
Study Chair: Esraa Badran, MD Assiut University
Study Director: Karim Abdallah, M.Sc Assiut University

Publications:
Responsible Party: Karim Abdallah, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03238807     History of Changes
Other Study ID Numbers: IntraUterine HCG Assiut
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Karim Abdallah, Assiut University:
hCG
Intrauterine hCG
IVF
ICSI

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs