Administration of Human Chorionic Gonadotrophin Before Secretory Transformation of Frozen-thawed Embryo Transfer Cycles

August 27, 2022 updated by: Alexandria University
Successful embryo implantation is complicated process that requires synchrony between good-quality embryos and receptive endometrium. Human chorionic gonadotropin (hCG), is one of the initial embryonic signals and the major embryoendometrial relationship regulator. This study will be conducted to to investigate the role of parenteral hCG used for the transfer of cryopreserved- thawed embryos with HRT cycles in the outcome of artificially prepared frozen embryo transfer (FET) cycles.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patient age ≤ 38 years.
  • Normal 3D transvaginal ultrasound.
  • At least two good quality embryos cryopreserved by vitrification.
  • No GnRH agonists administration before FET cycle.

Exclusion Criteria

  • Endometriosis.
  • Uterine anomalies.
  • Evidence of hydrosalpinx by hystrosalpingography or ultrasound.
  • Evidence of immune disease, hematological or hormonal disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HCG group
n Group 1 (hCG): participants will receive endometrial preparation with estrogen and an intramuscular hCG injection will before progesterone supplementation
Drug: Human Chorionic Gonadotrophin Intramuscular injection 10.000 IU
From the 12th to 13th day of the cycle when endometrium reached the optimal thickness ≥8 mm, group 1 (hCG) will receive 10.000 IU hCG intramuscular injection in the morning then vaginal suppository progesterone 400 mg twice a day will be started in the afternoon
No Intervention: control group
Group 2 (control): participants will receive the conventional endometrial preparation with estrogen followed by progesterone supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth delivery rate (LBR)
Time Frame: 7 months
Number of live births beyond 28 weeks of gestational age to the total number of FET cycles
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 2 weeks after positive pregnancy test
number of cases with observed gestational sac with embryonic heartbeat detected by ultrasound two weeks after positive pregnancy to the totoal number of frozen embryo transfer cycles.
2 weeks after positive pregnancy test
Implantation rate
Time Frame: 2 weeks after positive pregnancy test
proportion of the number of gestational sacs to the number of embryos transferred
2 weeks after positive pregnancy test
Miscarriage rate
Time Frame: 20 weeks gestational age
number of lost before the 20th week of gestation to the number of clinical pregnancies
20 weeks gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

June 20, 2022

Study Completion (Actual)

July 30, 2022

Study Registration Dates

First Submitted

February 8, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 27, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCG in FET cycles

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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