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Female InfertilityPhase 4NCT05281341

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

A Phase 4 study testing Growth Hormone in people with Female Infertility, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Female Infertility
What is being tested?
Growth Hormone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteEgypt
Study dates
13 Jan 2020to 13 Feb 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • faculty of medicine, Alexandria University

    Alexandria, 21131

Other trials in Egypt

About this study

Official title: 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).

Being tested
Growth Hormone
Keywords
Growth hormone, Poor responder, Poseidon group,, ICSI
Medical subject headings
Infertility, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Growth HormoneDrug

    Also called somatropin 4 IU

    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

Study groups in NCT05281341
Study groupRoleWhat they receive
Poseidon Group 4A & 3AExperimental80 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.
Receives: Drug: Growth Hormone
poseidon Group 4B & 3BNo intervention80 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Live birth rate

    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.

    Measured: 28 gestational weeks

Secondary outcomes (7)

  1. Serum E2 level

    Serum Estradiol level on day of human chorionic gonadotropin (hCG) in pg.

    Measured: 2-3 weeks

  2. Endometrial thickness

    Endometrial thickness on day of hCG in mm

    Measured: 2-3 weeks

  3. Fertilization rate

    number of 2pn oocytes to the total number of injected oocytes

    Measured: 1 day after oocyte retrieval

  4. Number of day 3 embryos

    Total number of available embryos on day 3 after oocyte retrieval

    Measured: 3 days after oocyte retrieval

  5. Clinical pregnancy rate

    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

    Measured: 2 weeks after positive pregnancy test

  6. Implantation rate

    Calculated as the ratio of the number of gestational sacs detected by sonography to the total number of embryos transferred

    Measured: 2 weeks after positive pregnancy test

  7. Miscarriage rate

    The number fetal losses per clinical pregnancies

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2022
  2. Study start13 Jan 2020
  3. Primary completion10 Dec 2021
  4. Study completion13 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05281341
Sponsor's protocol ID
0305406
Status last verified
Dec 2021
First submitted
7 Mar 2022
Last updated
9 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Oudendijk JF, Yarde F, Eijkemans MJ, Broekmans FJ, Broer SL. The poor responder in IVF: is the prognosis always poor?: a systematic review. Hum Reprod Update. 2012 Jan-Feb;18(1):1-11. doi: 10.1093/humupd/dmr037. Epub 2011 Oct 10.

    PubMed 21987525

  • Abu-Musa A, Haahr T, Humaidan P. Novel Physiology and Definition of Poor Ovarian Response; Clinical Recommendations. Int J Mol Sci. 2020 Mar 19;21(6):2110. doi: 10.3390/ijms21062110.

    PubMed 32204404

  • Humaidan P, Alviggi C, Fischer R, Esteves SC. The novel POSEIDON stratification of 'Low prognosis patients in Assisted Reproductive Technology' and its proposed marker of successful outcome. F1000Res. 2016 Dec 23;5:2911. doi: 10.12688/f1000research.10382.1. eCollection 2016.

    PubMed 28232864

  • Poseidon Group (Patient-Oriented Strategies Encompassing IndividualizeD Oocyte Number); Alviggi C, Andersen CY, Buehler K, Conforti A, De Placido G, Esteves SC, Fischer R, Galliano D, Polyzos NP, Sunkara SK, Ubaldi FM, Humaidan P. A new more detailed stratification of low responders to ovarian stimulation: from a poor ovarian response to a low prognosis concept. Fertil Steril. 2016 Jun;105(6):1452-3. doi: 10.1016/j.fertnstert.2016.02.005. Epub 2016 Feb 26. No abstract available.

    PubMed 26921622

  • Xu YM, Hao GM, Gao BL. Application of Growth Hormone in in vitro Fertilization. Front Endocrinol (Lausanne). 2019 Jul 23;10:502. doi: 10.3389/fendo.2019.00502. eCollection 2019.

    PubMed 31396161

  • Li XL, Wang L, Lv F, Huang XM, Wang LP, Pan Y, Zhang XM. The influence of different growth hormone addition protocols to poor ovarian responders on clinical outcomes in controlled ovary stimulation cycles: A systematic review and meta-analysis. Medicine (Baltimore). 2017 Mar;96(12):e6443. doi: 10.1097/MD.0000000000006443.

    PubMed 28328856

  • Yang P, Wu R, Zhang H. The effect of growth hormone supplementation in poor ovarian responders undergoing IVF or ICSI: a meta-analysis of randomized controlled trials. Reprod Biol Endocrinol. 2020 Jul 29;18(1):76. doi: 10.1186/s12958-020-00632-w.

    PubMed 32727608

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Growth Hormone in people with Female Infertility, run by Alexandria University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Live birth rate (time frame: 28 gestational weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05281341, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.

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