Growth Hormone For Poor Ovarian Reserve Patients in ICSI Trials

April 26, 2023 updated by: Sara Abdallah Mohamed Salem, Beni-Suef University

Effect of Growth Hormone Adjuvant Therapy on ICSI Trials For Poor Ovarian Reserve Patients

Effect of Growth Hormone Adjuvant Therapy on ICSI Trials For Poor ovarian Reserve Patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To study the effect of growth hormone as adjuvant treatment on the outcomes of ICSI trials in poor ovarian reserve patients.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 3

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
    • Beni Suef
      • Banī Suwayf, Beni Suef, Egypt, 62521
        • Recruiting
        • Beni-Suef University
        • Contact:

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

According to Bologna criteria (((at least two )))of the following features must be present:

  1. Advanced maternal age (40years).
  2. A previous poor ovarian response with 3 oocytes retrieved after conventional stimulation

  3. An abnormal ovarian reserve test (ORT)

    • antral follicle count (AFC)<7 or
    • anti-Müllerian hormone (AMH)<1.1ng/ml.

Exclusion Criteria:

  1. Any known contraindications to the approved fertility drugs.
  2. Any contraindications to growth hormone, pregnancy (to be ruled out and documented before GH treatment)

4- Hydrosalpinx 5- Uterine malformations or abnormal uterine cavity. 6- Basal FSH more than 17 IU. 7- Abnormal karyotyping 8- Partner with severe male factor 9- Uncontrolled endocrinopathies: DM, hyperthyroidism, hypothyroidism.

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: Growth Hormone adjuvant treatment
Growth hormone in this trial will use 4 IU of recombinant GH (Somatotropin, ) by day after day subcutaneous injection for 6 weeks before starting cycle. And on start day of induction ( Day 2 to 3) until the day of the human chorionic gonadotropin (hCG) trigger.
Drug: 4 IU of recombinant GH (Somatotropin )
4 IU of recombinant GH
Other Names:
  • (Somatotropin )
No Intervention: control
standard controlled ovarian stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy rate
Time Frame: ICSI trial (1month)
HCG positive
ICSI trial (1month)

Collaborators and Investigators

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

Sponsor

Beni-Suef University

Investigators

  • Study Chair: Beni-Suef University, Faculty of Medicine Beni-Suef University

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)

February 1, 2022

Primary Completion (Anticipated)

September 4, 2023

Study Completion (Anticipated)

October 30, 2023

Study Registration Dates

First Submitted

October 27, 2022

First Submitted That Met QC Criteria

October 27, 2022

First Posted (Actual)

November 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • FMBSUREC/01022022/Hemida

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To study the effect of growth hormone as adjuvant treatment on the outcomes of ICSI trials in poor ovarian reserve patients

Drug and device information, study documents

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

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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