NCT03027843

The Effect of Growth Hormone in Assisted Reproductive Technology Clinical Outcome of Poor Responder

A Pilot Study of the Effect of Growth Hormone in Assisted Reproductive Technology Clinical Outcome of Poor Responder

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: Female
• Age: 30 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Assisted reproduction treatment in patients with low ovarian reserve is a big difficult clinical problem. Growth hormone (GH) is crucial in the development of follicles since preantral follicle to ovulation and can promote steroid hormones and gamete formation, increase the granular cell sensitivity,and inhibition of follicular atresia. Latest research shows that GH can improve egg quality through regulating mitochondrial function of the oocytes and increase the rate of embryo euploid. It becomes a new argument in that promotion of clinical pregnancy rate in assisted reproduction treatment. GH applied in the field of assisted reproduction 30 years experience of applicable people, but drug dosage, drug intervention time continue to explore. 2015 China assisted reproductive stimulate ovulation medicine expert consensus recommend joint GH for poor ovarian response, repeated implantation failure patients and older patients assisted fertility treatment, but not on the specific use time limit, the daily dose of drugs and curative effect. How to maximize growth hormone potential advantage in improving the egg quality bothers the clinical doctors. We had a self-controlled retrospective analyses in growth hormone application and found that the average daily injections of GH dose 2 iu for 45 days can significantly improve the embryo quality in patients with low ovarian reaction. And now long-acting recombinant human growth hormone is available, which make it convenient for patients. A forward-looking experimental is expected to answer clinical practical problems and provide proper GH regimen for low ovarian responder.

Detailed description

This study is a pilot study to investigate the effect of growth hormone in assisted reproductive technology clinical outcome of poor responder. Design: randomized controlled trial. Setting: Assisted reproductive technologies unit. Patients: patients diagnosed poor ovarian responder who is in accordance with the inclusion criteria, and not meet the exclusion criteria, who had repeated IVF treatment from Mar 2017 to Aug 2019. Intervention: The comparison was made between GH group and the control group, both groups are conducted with the mini-dose GnRH-a long protocol for IVF treatment. GH group use Long-acting recombinant human growth hormone 14IU qw, until the day of hCG. Main outcome measures: The primary outcome of the study is live birth rate. The secondary outcomes were clinical pregnancy rate, number of oocytes retrieved, fertility rate, normal fertilization rate, rate of transferable embryo and good quality embryo rate.

Conditions

• Low Ovarian Reserve

Interventions

Type	Name	Description
DRUG	Growth Hormone	in GH group, patients have weekly injections of GH dose 14 iu, until the day of hCG.

Timeline

• Start date: 2017-03-01
• Primary completion: 2019-08-01
• Completion: 2020-04-01
• First posted: 2017-01-23
• Last updated: 2017-01-23