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

NCT04384783 | Unknown

• 1 other identifier: 20201A011002
• Study Type: observational
• Target: 114
• Locations: 0 countries
• Sites: N/A

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

Keywords

GH; low ovarian reserve; POSEIDON

Outcome Measures

Primary Outcomes (1)

• rate of good quality embryos

  the number of good quality embryos divide by the number of transferrable embryos

  2 years

Secondary Outcomes (4)

• number of oocytes retrieved

  2 years

• fertilization rate

  2 years

• clinical pregnancy rate

  2 years

• live birth rate

  2 years

Study Arms (2)

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.

Drug: growth hormone

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.

Interventions

growth hormone DRUG

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

GH group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients enroll for study are based on POSEIDON criteria\[1\], and with informed consent.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Guangzhou First People's Hospital: lead

Related 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 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.

  PMID: 26921622 RESULT

MeSH Terms

Interventions

Growth Hormone

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• meihong Cai, master

  Guangzhou First People's Hospital

  STUDY DIRECTOR

Central Study Contacts

meihong Cai, master

CONTACT

15889936054; caimhong@mail2.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 12, 2020
• Study Start: May 26, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share