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

Female Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05281341
• Other study ID #: 0305406
• Status: Completed
• Phase: Phase 4
• Start date: January 13, 2020
• Est. completion date: February 13, 2022

Study information

• Verified date: December 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 13, 2022
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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%)

Related Conditions & MeSH terms

• Female Infertility
• Infertility
• Infertility, Female

Intervention

Drug:
• Growth Hormone
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

Locations

Country	Name	City	State
Egypt	faculty of medicine, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (7)

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). pii: E2110. doi: 10.3390/ijms21062110. Review. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

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