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Efficacy of Growth Hormone Supplementation With Gonadotrophins in IVF/ICSI for Poor Responders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03759301
Recruitment Status : Completed
First Posted : November 29, 2018
Last Update Posted : June 24, 2019
Sponsor:
Collaborator:
National Research Center, Egypt
Information provided by (Responsible Party):
Emad Roushdy, ClinAmygate

Brief Summary:
The objective of this study is to assess the effectiveness of adjuvant growth hormone injection during controlled ovarian stimulation, in poor responder women undergoing intracytoplasmic sperm injection (ICSI) procedures.

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: Growth Hormones Somatropin Recombinant Drug: Placebo saline solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Growth Hormone Supplementation With Gonadotrophins in IVF/ICSI for Poor Responders; a Randomized Controlled Trial
Actual Study Start Date : December 20, 2018
Actual Primary Completion Date : May 5, 2019
Actual Study Completion Date : June 5, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Growth Hormones Somatropin Recombinant
Growth hormone (Somatropin) 4 IU/day subcutaneous from the 2nd day of the cycle and stopped 1 day before ovum pickup for the treatment group which consists of 70 women.
Drug: Growth Hormones Somatropin Recombinant
Growth Hormones Somatropin Recombinant 4 IU/day subcutaneous from the 2nd day of the cycle and stopped 1 day before ovum pickup
Other Name: Cetrorelix

Placebo Comparator: Placebo saline solution
Control group consisting of 70 women who will receive subcutaneous placebo injection in the same dosing as the treatment group
Drug: Placebo saline solution
same volume as growth hormone ampule used
Other Name: Cetrorelix




Primary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: 3 weeks ]
    The main outcome is clinical pregnancy per allocated woman, defined as the presence of at least one fetus with heart beat.


Secondary Outcome Measures :
  1. E2 levels [ Time Frame: Day 1 of COS, the same day of Human Chorionic Gonadotropin (HCG) injection ]
    Human Chorionic Gonadotropin (HCG) is given to induce triggering of ovulation then ovum pick up is scheduled 36 hour after the injection.

  2. Number of oocytes collected [ Time Frame: Day 6 of COS ]
    Transvaginal ultrasound will be done starting from day 6 of COS for assessment of follicular development and assessment of endometrial thickness, serial E2 measurement will be scheduled to start on day 6 of COS repeating every other day

  3. Metaphase I (MI) and Metaphase II (MII) oocyte number [ Time Frame: Day 6 of COS ]
    Transvaginal ultrasound will be done starting from day 6 of COS for assessment of follicular development and assessment of endometrial thickness, serial E2 measurement will be scheduled to start on day 6 of COS repeating every other day

  4. Number of Pronucleus [ Time Frame: Day 6 of COS ]
    Transvaginal ultrasound will be done starting from day 6 of COS for assessment of follicular development and assessment of endometrial thickness, serial E2 measurement will be scheduled to start on day 6 of COS repeating every other day

  5. Multiple pregnancy [ Time Frame: 6 weeks from last period ]
    Multiple pregnancy



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Ages Eligible for Study:   25 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 25 to 38 years old.
  • IVF previous poor responders: at least two failed cycles with < five oocytes or abnormal ORT e.g. antimullerian hormone < 1
  • Patients with unexplained infertility.
  • Normal follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin and ovarian ultrasound.
  • Normal pelvic ultrasound including 3D ultrasound of the uterus with no detected hydrosalpinx.

Exclusion Criteria:

  • Refusal to participate in the study
  • Patients with known medical disease (e.g. severe hypertension or hepatic disease).
  • Altered karyotype in one or both partners.
  • History of chronic, autoimmune or metabolic diseases
  • Presence of endocrinopathies.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759301


Locations
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Egypt
Al Azhar University Hospitals (Kasr Al-Aini)
Cairo, Egypt
Sponsors and Collaborators
ClinAmygate
National Research Center, Egypt
Investigators
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Principal Investigator: Mohamed M Shafeek, MSc Al-Azhar University

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Responsible Party: Emad Roushdy, Director, ClinAmygate
ClinicalTrials.gov Identifier: NCT03759301    
Other Study ID Numbers: NRC 0214
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emad Roushdy, ClinAmygate:
Growth Hormone
IVF/ICSI
Poor Responders
Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Cetrorelix
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Hormone Antagonists