NCT04588844

Effect of Growth Hormone Injection on the IVF/ICSI Outcome of Patients With Poor Ovarian Reserve.

Effect of Polyethylene Glycol Recombinant Human Growth Hormone Injection on the IVF/ICSI Outcome of Patients With Poor Ovarian Reserve

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: Female
• Age: 35 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Declined fertility and ovarian reserve in older women are associated with lower density of Growth hormone (GH) receptors and dysregulation in GH secretion. GH can regulate the expression of growth hormone receptor and strengthen the function of mitochondria, which could improve the quality of the female oocyte. In this study, a prospective randomized control will be conducted to explore the effect of GH adjuvant therapy on clinical outcome of in vitro fertilization.

Detailed description

Eligible subjects will be randomly assigned into either the study groups (receive somatropin co-treatment) or the control group (without sopmatropin treatment). Polyethylene glycol recombinant human somatropin will be injected weekly (3mg/per week) for approximately 6 weeks, i.e. from the beginning of preceding menstruation cycle until the day of ovum pickup. Both groups will receive a similar common protocol for ovarian stimulation. In vitro fertilization with or without intracytoplasmic sperm injection will be performed according to semen parameters. All embryos will undergo culture for blastocyst and the obtained blastocysts will be vitrified for deferred frozen embryo transfer. The Blastocyst formation rate will be the primary outcome measure.

Conditions

• Poor Ovarian Reserve

Interventions

Type	Name	Description
DRUG	Polyethylene Glycol Recombinant Human Somatropin	Polyethylene glycol recombinant human somatropin will be injected weekly (3mg/per week) from the beginning of preceding menstruation cycle until the day of ovum pickup.

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-03-20
• Completion: 2023-03-20
• First posted: 2020-10-19
• Last updated: 2020-10-19