Intrauterine Injection of Human Chorionic Gonadotrophin and Pregnancy Rate in ICSI

NCT03445910 | Completed

• 1 other identifier: 3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Repeated Implantation Failure

Keywords

human chorionic gonadotropin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• biochemical pregnancy

  two weeks following embryo transfere

• clinical pregnancy

  eight weeks from last menstrual period

Study Arms (2)

Human chorionic gonadotrophin

EXPERIMENTAL

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

control

NO INTERVENTION

The Control Group included 50 patients who went through the ICSI conventional protocol without intrauterine injection.

Interventions

Human chorionic gonadotropin DRUG

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

Also known as: Chorimone, pregnyl

Human chorionic gonadotrophin

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A- Age between 20 and 35 years old.
• B- Patients undergoing ICSI trial after one or more previous failure.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Chorionic Gonadotropin

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

• Hayam F Mohammad, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisted professor of obstetrics and gynecology

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: February 26, 2018
• Study Start: February 20, 2018
• Primary Completion: June 1, 2018
• Study Completion: July 30, 2018
• Last Updated: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)