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

NCT ID: NCT04384783

Last Updated: 2020-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 114 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-26
• Study Completion Date: 2022-04-30

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.

Conditions

GH; Low Ovarian Reserve

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

GH group

GH group: Participants diagnosed POR according to POSEIDON criteria with low ovarian reserve undergo IVF in our center with long protocol or antagonist protocol and is adjuvant with GH 2IU/d from previous menstrual period for about six weeks.

growth hormone

Intervention Type: DRUG

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

NGH group

NGH (non-GH) group: Participants diagnosed POR according to POSEIDON criteria with low reserve undergo IVF in our center with long protocol or antagonist protocol without GH adjuvant.

No interventions assigned to this group

Interventions

growth hormone

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou First People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

meihong Cai, master

Role: STUDY_DIRECTOR

Guangzhou First People's Hospital

Central Contacts

meihong Cai, master

Role: CONTACT

caimhong@mail2.sysu.edu.cn

15889936054

References

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.

Reference Type: RESULT

PMID: 26921622 (View on PubMed)

Other Identifiers

20201A011002

Identifier Type: -

Identifier Source: org_study_id