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Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT03759301 (opens ClinicalTrials.gov in a new tab)Other idNRC 0214
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
156 participants (actual)
Sponsor
ClinAmygate · Other
Design
Randomized · Triple masking
Countries
1 country

Egypt

Start
20 Dec 2018
Primary completion
5 May 2019
Completion
5 Jun 2019
First posted
29 Nov 2018
Last update posted
24 Jun 2019
Conditions
Infertility, Female

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201820192020
  1. Ph 4

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

    NCT03759301

    20 Dec 2018 to 5 Jun 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Growth Hormones Somatropin RecombinantDrug
  • Placebo saline solutionDrug

Arms2

  • 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.

  • 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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. clinical pregnancy rate

    Time frame · 3 weeks

    Registry description

    The main outcome is clinical pregnancy per allocated woman, defined as the presence of at least one fetus with heart beat.

Secondary outcomes(5)

  1. E2 levels

    Time frame · Day 1 of COS, the same day of Human Chorionic Gonadotropin (HCG) injection

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    Multiple pregnancy

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedSood A, Mohiyiddeen G, Ahmad G, Fitzgerald C, Watson A, Mohiyiddeen L. Growth hormone for in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD000099. doi: 10.1002/14651858.CD000099.pub4. PMID 34808697
  • DerivedMohammad EH, Abou El Serour AG, Mohamed EAH, Abbasy AH, Zaatar M, Rageh KA, Shafeek MM, Issak ER. Efficacy of growth hormone supplementation with ultrashort GnRH antagonist in IVF/ICSI for poor responders; randomized controlled trial. Taiwan J Obstet Gynecol. 2021 Jan;60(1):51-55. doi: 10.1016/j.tjog.2020.10.003. PMID 33495008

Eligibility

Who could join, as posted.

Sex
Female
Age
from 25 Years up to 38 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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