To Explore the Effect of GH on Outcomes of IVF and Telomerase Activity of Granulosa Cells in Women With POR

To Explore the Effect of Growth Hormone on Outcomes of in Vitro Fertilisation and Telomerase Activity of Granulosa Cells in Women With Poor Ovarian Response

It is still a big difficult clinical problem for patients with poor ovarian reserve undergoing in vitro fertilization. The decrease in both quality and quantity of egg are the main cause for poor clinical prognosis. Growth hormone (GH) is currently one of the main adjuvant for improving pregnancy outcomes in patients with POR, and the investigators' previous retrospective study suggested GH was effective in live birth rate in subgroup of patients with POR older than 35 years old. To further figure out the mechanism of GH effectiveness in POR patients and the effect on clinical outcomes in POR patients, the investigators designed this prospective observational cohort study.

Study Overview

• Status: Unknown
• Conditions: GH; Poor Ovarian Reserve Based on POSEIDON
• Intervention / Treatment: Drug: growth hormone

• Study Type: Observational
• Enrollment (Anticipated): 40

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The study population includes patients diagnosed as POR based on POSEIDON criteria and with low ovairan reserve, as well as patients with normal ovairan reserve seeking for ART help due to pelvic tubal factors.

Description

Inclusion Criteria:

For patients with poor ovarian response, the criteria is based on POSEIDON criteria[1]:

1. low ovarian reserve(AMH <1.2ng/ml, or AFC <5);
2. younger than 40.

For patients with normal ovarian reserve, the criteria is as follow:

1. Patients who are between 20-40 years old;
2. clinical diagnosis of non-functional fallopian tube;
3. regular menstrual cycles.

Exclusion Criteria:

1. BMI ≥28kg/m2;
2. 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. adenomyosis or endometriosis confirmed by surgery;
5. untreated abnormal intrauterine environment, such as uterine effusion, endometritis, etc;
6. untreated hydrosalpinx;
7. polycystic ovary syndrome.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GH-POR; 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-POR; Participants diagnosed POR according to POSEIDON criteria with low reserve undergo IVF in our center with long protocol or antagonist protocol without GH adjuvant.
NGH-NOR; Participants with normal ovarian 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
clinical pregnancy rate	Clinical pregnancy means pregnancy sac is seen intrauterine under ultrasound 7 weeks after embryo transferred.	1-2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
live birth rate	Live birth rate(%): number of live birth/ transferred cycle.	1-2 years
number of oocytes retrieved	number of oocytes retrieved on day of OPU	1-2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
telomerase activity of granulosa cells	detection of telomerase activity of granulosa cells in wasted follicular fluid	1-2 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): November 30, 2021
• Study Completion (Anticipated): November 30, 2021

Study Registration Dates

• First Submitted: May 8, 2020
• First Submitted That Met QC Criteria: May 11, 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: April 1, 2020

More Information

Terms related to this study

• Keywords: growth hormone; POSEIDON; low ovarian reserve; prospective observational cohort study
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormones
• Other Study ID Numbers: 2019001

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