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To Explore the Effect of GH Pretreatment on Clinical Outcomes in Patients With Low Ovarian Reserve

To Explore the Effect of Low-dose Long Term Growth Hormone Pretreatment on Clinical Pregnancy Outcomes in Patients With Low Ovarian Reserve

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04384783
Enrollment
114
Registered
2020-05-12
Start date
2020-05-26
Completion date
2022-04-30
Last updated
2020-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GH, Low Ovarian Reserve

Keywords

GH, low ovarian reserve, POSEIDON

Brief summary

Growth hormone (GH) has been used in the field of assisted reproduction technology for over 30 years. Studies for GH have been exploring in the applicable population, drug dosage, starting time and time limitation. In previous clinical applications, it worked as an adjuvant drug for improving ovarian reactivity. With the development of basic research and clinical applications, the improvement effect on egg quality is gradually recognized. However, which protocol of GH may work well and maximize the clinical effect remains mystery. The investigators' previous self-controlled retrospective research about 380 cases treated with GH found that the average daily injection of GH dose of 2IU for about 6 weeks can significantly improve embryo quality and clinical pregnancy outcomes of the patients with low ovarian response. The new POSEIDON standard clearly groups people with low prognosis and better classifies heterogeneous people, which may help classifying the specific subgroup that benefit most from GH of poor ovarian response (POR). The investigators design a prospective cohort study to explore whether GH low-dose long-term pretreatment can improve the outcome of assisted pregnancy and its possible mechanism in people with low ovarian reserve.

Interventions

DRUGgrowth hormone

growth hormone was adjuvanted 2IU/d from previous menstrual period for about six weeks.

Sponsors

Guangzhou First People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

1. low ovarian reserve(AMH \<1.2ng/ml, or AFC \<5); 2. patients who have not participated in any clinical trials within the three months; 3. patients who voluntarily signed informed consent.

Exclusion criteria

1. patients with BMI ≥30kg/m2; 2. patients with medical diseases such as endocrine and metabolic diseases, autoimmune disease, etc; 3. ovarian neoplasm that ≥4 cm in diameter and has no clear pathological diagnosis by surgery; 4. complicated with adenomyosis, endometriosis confirmed by surgery; 5. patients with untreated abnormal intrauterine environment, such as uterine effusion, endometritis, etc; 6. untreated hydrosalpinx.

Design outcomes

Primary

MeasureTime frameDescription
rate of good quality embryos2 yearsthe number of good quality embryos divide by the number of transferrable embryos

Secondary

MeasureTime frameDescription
number of oocytes retrieved2 yearsnumber of oocytes retrieved
fertilization rate2 yearsthe fertilized oocytes divided by the number of oocytes retrieved
clinical pregnancy rate2 yearsthe patients confirmed clinical pregnancy divided by the patients undergoing fresh embryo transferred.
live birth rate2 yearsthe patients have a live birth divided by the patients undergoing fresh embryo transferred.

Contacts

Primary Contactmeihong Cai, master
caimhong@mail2.sysu.edu.cn15889936054

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026