Effect of GH Administration in Poor Responders Undergoing Intracytoplasmic Sperm Injection (ICSI)

August 8, 2022 updated by: Alexandria University

Effect of Growth Hormone Administration With Controlled Ovarian Stimulation in Expected Poor Responders POSEIDON Group 3 and 4 Undergoing ICSI Using Antagonist Protocol

Despite the use of various treatment strategies, poor response to ovarian stimulation remains a major clinical challenge with lower chance to obtain sufficient number of oocytes and thus less likely to conceive with high risk of cycle cancellation. The aim of this study is to evaluate the effect of recombinant human GH administration to gonadotropins on clinical and laboratory ICSI outcomes in expected poor responders more and less than 35 years (Poseidon group 4 and 3 respectively).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

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, 21131
        • Faculty of Medicine, 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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Infertile women aged 20-45 years.
  2. AFC <5.
  3. AMH level <1.2 ng/ml.
  4. Have two normal ovaries and normal uterine cavity.

Exclusion Criteria:

  1. Body mass index (BMI) >30 kg/m2.
  2. Follicle Stimulating Hormone (FSH) > 15 IU/L.
  3. History of abnormal karyotype in one or both partners.
  4. Endocrine, metabolic or autoimmune disorders, such as diabetes, thyroid disorder, and polycystic ovary syndrome (PCOS).
  5. Women with a known medical disease (e.g. severe hypertension or hepatic disease).
  6. Endometriosis.
  7. Previous ovarian surgery.
  8. Current or history of malignancies, chemotherapy or radiotherapy.
  9. Severe male actor (total motile sperm count <1×106 or normal morphology <1%)

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: Poseidon Group 4A & 3A
80 eligible infertile women fulfilling the criteria of Poseidon Group 4 (35 years or more and AMH <1.2ng/ml) will be randomized into Group 4A will receive controlled ovarian stimulation (COS) and growth hormone (GH) and Group 4B will receive COS only. Similarly, 80 eligible infertile women fulfilling the criteria of Poseidon Group 3 (less than 35 years and AMH <1.2ng/ml) will be randomized into Group 3A will receive COS and GH and Group 3B will receive COS only.
Drug: Growth Hormone
In GH groups (Group 4A & 3A), patients will receive additional treatment with GH (Somatropin, 4 IU/day, subcutaneous injection), daily beginning on the initial day of gonadotropin stimulation until triggering the oocyte maturation by hCG. Control groups (Group 4B & 3B) will receive only standard COS without GH supplementation
Other Names:
  • somatropin 4 IU
No Intervention: poseidon Group 4B & 3B
80 eligible infertile women fulfilling the criteria of Poseidon Group 4 (35 years or more and AMH <1.2ng/ml) will be randomized into Group 4A will receive controlled ovarian stimulation (COS) and growth hormone (GH) and Group 4B will receive COS only. Similarly, 80 eligible infertile women fulfilling the criteria of Poseidon Group 3 (less than 35 years and AMH <1.2ng/ml) will be randomized into Group 3A will receive COS and GH and Group 3B will receive COS only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate
Time Frame: 28 gestational weeks
calculated as the number of live births (defined as at least one live born after 28 weeks of gestation) divided by the total number of patients who performed pregnancy tests.
28 gestational weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum E2 level
Time Frame: 2-3 weeks
Serum Estradiol level on day of human chorionic gonadotropin (hCG) in pg.
2-3 weeks
Endometrial thickness
Time Frame: 2-3 weeks
Endometrial thickness on day of hCG in mm
2-3 weeks
Fertilization rate
Time Frame: 1 day after oocyte retrieval
number of 2pn oocytes to the total number of injected oocytes
1 day after oocyte retrieval
Number of day 3 embryos
Time Frame: 3 days after oocyte retrieval
Total number of available embryos on day 3 after oocyte retrieval
3 days after oocyte retrieval
Clinical pregnancy rate
Time Frame: 2 weeks after positive pregnancy test
Calculated as the number of clinical pregnancies (defined as the presence of a gestational sac with positive heart beat detected by transvaginal ultrasound scan 2 weeks after positive pregnancy test) divided by the number of embryo transfer procedures
2 weeks after positive pregnancy test
Implantation rate
Time Frame: 2 weeks after positive pregnancy test
Calculated as the ratio of the number of gestational sacs detected by sonography to the total number of embryos transferred
2 weeks after positive pregnancy test
Miscarriage rate
Time Frame: 20 weeks
The number fetal losses per clinical pregnancies
20 weeks

Collaborators and Investigators

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

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Sherif Anis, phD, 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 13, 2020

Primary Completion (Actual)

December 10, 2021

Study Completion (Actual)

February 13, 2022

Study Registration Dates

First Submitted

March 7, 2022

First Submitted That Met QC Criteria

March 7, 2022

First Posted (Actual)

March 16, 2022

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0305406

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.

Clinical Trials on Female Infertility

Clinical Trials on Growth Hormone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe