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

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.

Study Overview

• Status: Unknown
• Conditions: Low Ovarian Reserve; GH
• Intervention / Treatment: Drug: growth hormone

• Study Type: Observational
• Enrollment (Anticipated): 114

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of good quality embryos	the number of good quality embryos divide by the number of transferrable embryos	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of oocytes retrieved	number of oocytes retrieved	2 years
fertilization rate	the fertilized oocytes divided by the number of oocytes retrieved	2 years
clinical pregnancy rate	the patients confirmed clinical pregnancy divided by the patients undergoing fresh embryo transferred.	2 years
live birth rate	the patients have a live birth divided by the patients undergoing fresh embryo transferred.	2 years

Collaborators and Investigators

• Sponsor: Guangzhou First People's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 26, 2020
• Primary Completion (ANTICIPATED): April 30, 2022
• Study Completion (ANTICIPATED): April 30, 2022

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 8, 2020
• First Posted (ACTUAL): May 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 19, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: GH; POSEIDON; low ovarian reserve
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: 20201A011002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No