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

NCTNCT05281341Other id0305406

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 160 participants (actual)
Sponsor: Alexandria University · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Egypt
Start: 13 Jan 2020
Primary completion: 10 Dec 2021
Completion: 13 Feb 2022
First posted: 16 Mar 2022
Last update posted: 9 Aug 2022
Conditions: Female Infertility

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2020202120222023

Ph 4
Effect of GH Administration in Poor Responders Undergoing Intracytoplasmic Sperm Injection (ICSI)
NCT05281341
13 Jan 2020 to 13 Feb 2022

Registry summary

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

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).

Interventions

Growth HormoneDrug

Arms2

Experimental
Poseidon Group 4A & 3A
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.
No intervention
poseidon Group 4B & 3B
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Live birth rate
Time frame · 28 gestational weeks
Registry description
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(7)

Serum E2 level
Time frame · 2-3 weeks
Registry description
Serum Estradiol level on day of human chorionic gonadotropin (hCG) in pg.
Endometrial thickness
Time frame · 2-3 weeks
Registry description
Endometrial thickness on day of hCG in mm
Fertilization rate
Time frame · 1 day after oocyte retrieval
Registry description
number of 2pn oocytes to the total number of injected oocytes
Number of day 3 embryos
Time frame · 3 days after oocyte retrieval
Registry description
Total number of available embryos on day 3 after oocyte retrieval
Clinical pregnancy rate
Time frame · 2 weeks after positive pregnancy test
Registry description
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
Implantation rate
Time frame · 2 weeks after positive pregnancy test
Registry description
Calculated as the ratio of the number of gestational sacs detected by sonography to the total number of embryos transferred
Miscarriage rate
Time frame · 20 weeks
Registry description
The number fetal losses per clinical pregnancies

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.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 20 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Infertile women aged 20-45 years. 2. AFC \<5. 3. AMH level \<1.2 ng/ml. 4. Have two normal ovaries and normal uterine cavity. Exclusion Criteria: 1. Body mass index (BMI) \>30 kg/m2. 2. Follicle Stimulating Hormone (FSH) \> 15 IU/L. 3. History of abnormal karyotype in one or both partners. 4. Endocrine, metabolic or autoimmune disorders, such as diabetes, thyroid disorder, and polycystic ovary syndrome (PCOS). 5. Women with a known medical disease (e.g. severe hypertension or hepatic disease). 6. Endometriosis. 7. Previous ovarian surgery. 8. Current or history of malignancies, chemotherapy or radiotherapy. 9. Severe male actor (total motile sperm count \<1×106 or normal morphology \<1%)

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