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

NCT03238807 | Completed

• 1 other identifier: IntraUterine HCG Assiut
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; ART

Keywords

hCG; Intrauterine hCG; IVF; ICSI

Outcome Measures

Primary Outcomes (1)

• Live Birth Rate (LBR)

  calculated by the number of live births to the number of transferred embryos

  9 months

Secondary Outcomes (3)

• Clinical Pregnancy Rate (cPR)

  5 weeks

• Implantation Rate (IR)

  5 weeks

• Miscarriage rate (MR)

  3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Group that will receive intrauterine injection of human Chorionic Gonadotropin before ET

Drug: Human Chorionic Gonadotropin

Control Group

NO INTERVENTION

Control Group

Interventions

Human Chorionic Gonadotropin DRUG

500 IU of human Chorionic Gonadotropin

Also known as: Epifasi

Intervention Group

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University - Women's Health Hospital

Asyut, 71515, Egypt

Location

Related Publications (1)

• Abdallah KS, Makhlouf A, Badran E, El-Nashar IM, Al-Hussaini TK, Farghaly T, Mohamed HS, Mol BW, Abdelmagied AM. Intrauterine injection of HCG before embryo transfer: a parallel, double-blind randomized trial. Reprod Biomed Online. 2021 Oct;43(4):663-669. doi: 10.1016/j.rbmo.2021.06.011. Epub 2021 Jun 20.

  PMID: 34412973 RESULT

MeSH Terms

Conditions

Infertility

Interventions

Chorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins

Study Officials

• Ahmed Makhlouf, MD

  Assiut University

  PRINCIPAL INVESTIGATOR

• Hazem Saadeldine, MD

  Assiut University

  STUDY CHAIR

• Esraa Badran, MD

  Assiut University

  STUDY CHAIR

• Karim Abdallah, M.Sc

  Assiut University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double-Blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 3, 2017
• Study Start: July 8, 2018
• Primary Completion: October 4, 2020
• Study Completion: October 4, 2020
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Immediately after publication indefinitely.
• Access Criteria: Proposals should be directed to karimsayed88@hotmail.com. To gain access, data requestors will need to sign a data access agreement.

Locations

EG (1)