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

Low Ovarian Reserve Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04384783
• Other study ID #: 20201A011002
• Status: Not yet recruiting
• Start date: May 26, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2020
• Source: Guangzhou First People's Hospital
• Contact: meihong Cai, master
• Phone: 15889936054
• Email: caimhong[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• GH
• Low Ovarian Reserve

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou First People's Hospital

References & Publications (1)

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 stra — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of good quality embryos	the number of good quality embryos divide by the number of transferrable embryos	2 years
Secondary	number of oocytes retrieved	number of oocytes retrieved	2 years
Secondary	fertilization rate	the fertilized oocytes divided by the number of oocytes retrieved	2 years
Secondary	clinical pregnancy rate	the patients confirmed clinical pregnancy divided by the patients undergoing fresh embryo transferred.	2 years
Secondary	live birth rate	the patients have a live birth divided by the patients undergoing fresh embryo transferred.	2 years