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Completed

NCT Number: NCT05281341

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

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).

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Key information

Conditions

Female Infertility Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

faculty of medicine, Alexandria University

Alexandria, 21131, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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 <1×106 or normal morphology <1%)

Treatment and study plan

growth hormone

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Serum E2 level

    Time frame: 2-3 weeks

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

  2. Endometrial thickness

    Time frame: 2-3 weeks

    Endometrial thickness on day of hCG in mm

  3. Fertilization rate

    Time frame: 1 day after oocyte retrieval

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

  4. Number of day 3 embryos

    Time frame: 3 days after oocyte retrieval

    Total number of available embryos on day 3 after oocyte retrieval

  5. 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

  6. 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

  7. Miscarriage rate

    Time frame: 20 weeks

    The number fetal losses per clinical pregnancies

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Mar 16, 2022
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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