Back to resultsEffect of GH Administration in Poor Responders Undergoing Intracytoplasmic Sperm Injection (ICSI)
Primary Purpose
Female Infertility
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Growth Hormone
Sponsored by
About this trial
This is an interventional treatment trial for Female Infertility focused on measuring Growth hormone, Poor responder, Poseidon group,, ICSI
Eligibility Criteria
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%)
Sites / Locations
- faculty of medicine, Alexandria University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Poseidon Group 4A & 3A
poseidon Group 4B & 3B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Serum E2 level
Serum Estradiol level on day of human chorionic gonadotropin (hCG) in pg.
Endometrial thickness
Endometrial thickness on day of hCG in mm
Fertilization rate
number of 2pn oocytes to the total number of injected oocytes
Number of day 3 embryos
Total number of available embryos on day 3 after oocyte retrieval
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
Implantation rate
Calculated as the ratio of the number of gestational sacs detected by sonography to the total number of embryos transferred
Miscarriage rate
The number fetal losses per clinical pregnancies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05281341
Brief Title
Effect of GH Administration in Poor Responders Undergoing Intracytoplasmic Sperm Injection (ICSI)
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
February 13, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Infertility
Keywords
Growth hormone, Poor responder, Poseidon group,, ICSI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Poseidon Group 4A & 3A
Arm Type
Experimental
Arm Description
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.
Arm Title
poseidon Group 4B & 3B
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Growth Hormone
Other Intervention Name(s)
somatropin 4 IU
Intervention Description
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
Primary Outcome Measure Information:
Title
Live birth rate
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.
Time Frame
28 gestational weeks
Secondary Outcome Measure Information:
Title
Serum E2 level
Description
Serum Estradiol level on day of human chorionic gonadotropin (hCG) in pg.
Time Frame
2-3 weeks
Title
Endometrial thickness
Description
Endometrial thickness on day of hCG in mm
Time Frame
2-3 weeks
Title
Fertilization rate
Description
number of 2pn oocytes to the total number of injected oocytes
Time Frame
1 day after oocyte retrieval
Title
Number of day 3 embryos
Description
Total number of available embryos on day 3 after oocyte retrieval
Time Frame
3 days after oocyte retrieval
Title
Clinical pregnancy rate
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
Time Frame
2 weeks after positive pregnancy test
Title
Implantation rate
Description
Calculated as the ratio of the number of gestational sacs detected by sonography to the total number of embryos transferred
Time Frame
2 weeks after positive pregnancy test
Title
Miscarriage rate
Description
The number fetal losses per clinical pregnancies
Time Frame
20 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif Anis, phD
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of medicine, Alexandria University
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
21987525
Citation
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.
Results Reference
background
PubMed Identifier
32204404
Citation
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.
Results Reference
background
PubMed Identifier
28232864
Citation
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.
Results Reference
background
PubMed Identifier
26921622
Citation
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.
Results Reference
background
PubMed Identifier
31396161
Citation
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.
Results Reference
background
PubMed Identifier
28328856
Citation
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.
Results Reference
background
PubMed Identifier
32727608
Citation
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.
Results Reference
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Effect of GH Administration in Poor Responders Undergoing Intracytoplasmic Sperm Injection (ICSI)
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