NCT05281341

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
Last Updated

August 9, 2022

Status Verified

December 1, 2021

Enrollment Period

1.9 years

First QC Date

March 7, 2022

Last Update Submit

August 8, 2022

Conditions

Female Infertility

Keywords

Growth hormonePoor responderPoseidon group,ICSI

Outcome Measures

Primary Outcomes (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.

    28 gestational weeks

Secondary Outcomes (7)

  • Serum E2 level

    2-3 weeks

  • Endometrial thickness

    2-3 weeks

  • Fertilization rate

    1 day after oocyte retrieval

  • Number of day 3 embryos

    3 days after oocyte retrieval

  • Clinical pregnancy rate

    2 weeks after positive pregnancy test

  • +2 more secondary outcomes

Study Arms (2)

Poseidon Group 4A & 3A

EXPERIMENTAL

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

poseidon Group 4B & 3B

NO INTERVENTION

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.

Interventions

Growth HormoneDRUG

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

Also known as: somatropin 4 IU
Poseidon Group 4A & 3A

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • Previous ovarian surgery.
  • Current or history of malignancies, chemotherapy or radiotherapy.
  • Severe male actor (total motile sperm count \<1Ă—106 or normal morphology \<1%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of medicine, Alexandria University

Alexandria, 21131, Egypt

Location

Related Publications (7)

  • 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.

    PMID: 21987525BACKGROUND

  • 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.

    PMID: 32204404BACKGROUND

  • 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.

    PMID: 28232864BACKGROUND

  • 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.

    PMID: 26921622BACKGROUND

  • 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.

    PMID: 31396161BACKGROUND

  • 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.

    PMID: 28328856BACKGROUND

  • 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.

    PMID: 32727608BACKGROUND

MeSH Terms

Conditions

Infertility, Female

Interventions

Growth HormoneHuman Growth Hormone

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

Pituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Sherif Anis, phD

    Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2022

First Posted

March 16, 2022

Study Start

January 13, 2020

Primary Completion

December 10, 2021

Study Completion

February 13, 2022

Last Updated

August 9, 2022

Record last verified: 2021-12

Locations

EG(1)