Clinical trial NCT05281341: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Female Infertility
Keywords: Growth hormone
Poor responder
Poseidon group,
ICSI
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 160
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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%)

Primary outcomes:
measure: Live birth rate
timeFrame: 28 gestational weeks
Secondary outcomes:
measure: Serum E2 level
timeFrame: 2-3 weeks
measure: Endometrial thickness
timeFrame: 2-3 weeks
measure: Fertilization rate
timeFrame: 1 day after oocyte retrieval
measure: Number of day 3 embryos
timeFrame: 3 days after oocyte retrieval
measure: Clinical pregnancy rate
timeFrame: 2 weeks after positive pregnancy test
measure: Implantation rate
timeFrame: 2 weeks after positive pregnancy test
measure: Miscarriage rate
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: faculty of medicine, Alexandria University
Study officials:
affiliation: Alexandria University
name: Sherif Anis, phD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.