The Effect of Growth Hormone in Assisted Reproductive Technology Clinical Outcome of Poor Responder

January 19, 2017 updated by: Yanhong Deng, Sun Yat-sen University

A Pilot Study of the Effect of Growth Hormone in Assisted Reproductive Technology Clinical Outcome of Poor Responder

Assisted reproduction treatment in patients with low ovarian reserve is a big difficult clinical problem. Growth hormone (GH) is crucial in the development of follicles since preantral follicle to ovulation and can promote steroid hormones and gamete formation, increase the granular cell sensitivity,and inhibition of follicular atresia. Latest research shows that GH can improve egg quality through regulating mitochondrial function of the oocytes and increase the rate of embryo euploid. It becomes a new argument in that promotion of clinical pregnancy rate in assisted reproduction treatment. GH applied in the field of assisted reproduction 30 years experience of applicable people, but drug dosage, drug intervention time continue to explore. 2015 China assisted reproductive stimulate ovulation medicine expert consensus recommend joint GH for poor ovarian response, repeated implantation failure patients and older patients assisted fertility treatment, but not on the specific use time limit, the daily dose of drugs and curative effect. How to maximize growth hormone potential advantage in improving the egg quality bothers the clinical doctors. We had a self-controlled retrospective analyses in growth hormone application and found that the average daily injections of GH dose 2 iu for 45 days can significantly improve the embryo quality in patients with low ovarian reaction. And now long-acting recombinant human growth hormone is available, which make it convenient for patients. A forward-looking experimental is expected to answer clinical practical problems and provide proper GH regimen for low ovarian responder.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This study is a pilot study to investigate the effect of growth hormone in assisted reproductive technology clinical outcome of poor responder.

Design: randomized controlled trial. Setting: Assisted reproductive technologies unit. Patients: patients diagnosed poor ovarian responder who is in accordance with the inclusion criteria, and not meet the exclusion criteria, who had repeated IVF treatment from Mar 2017 to Aug 2019.

Intervention: The comparison was made between GH group and the control group, both groups are conducted with the mini-dose GnRH-a long protocol for IVF treatment. GH group use Long-acting recombinant human growth hormone 14IU qw, until the day of hCG.

Main outcome measures: The primary outcome of the study is live birth rate. The secondary outcomes were clinical pregnancy rate, number of oocytes retrieved, fertility rate, normal fertilization rate, rate of transferable embryo and good quality embryo rate.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women age ≥35 years and ≤40 years.
  2. 2≤ AFC≤6, and AMH level ≥0.5 and≤ 1.1 ng/ml.
  3. Previous failed transfer cycle ≥2
  4. Didn't participate in other clinical subjects in three months.
  5. Written informed consent.

Exclusion Criteria:

  1. Body mass index (BMI) ≥25 kg/m2.
  2. Endocrine metabolic disease, such as diabetes, insulin resistance, hyperthyroidism, Cushing's syndrome, hyperprolactinemia.
  3. Hypertension (systolic blood pressure ≥140mmHg and diastolic blood pressure≥90mmHg.
  4. Autoimmune diseases was definitively diagnosed, such as systemic lupus erythematosus, Sjogren's syndrome, Hashimoto's Thyroiditis, multiple sclerosis, rheumatoid arthritis, autoimmune hemolytic anemia, recurrent miscarriage.
  5. Ovarian neoplasm that ≥4 cm in diameter and has no clear pathological diagnosis by surgery.
  6. Complicated with adenomyosis, endometriosis confirmed by surgery, ovarian endometriosis cyst ≥2 cm by ultrasound, all kind of malignant tumors or precancerous disease.
  7. Untreated hydrosalpinx.

Eliminate or falls off Criteria:

  1. Withdraw drug and take appropriate treatment measures if serious adverse events happen during the trial, and subjects will be off.
  2. Patients that have bad compliance.
  3. Subjects are found breach the inclusion criteria, or in accordance with exclusion criteria during the test, excluded.
  4. Patients request withdrawal and exit the trial because adverse events occur during the trial.
  5. No record about treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GH group
patients in group mini-dose GnRH-a long protocol combine with growth hormone
Drug: Growth Hormone
in GH group, patients have weekly injections of GH dose 14 iu, until the day of hCG.
Other Names:
  • somatotropin;GH;somatotrophin;somatotropic
No Intervention: control group
patients in group mini-dose GnRH-a long protocol without growth hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live birth rate
Time Frame: 1-2year
Live birth rate(%): number of live birth/ transferred cycle.Compare the live birth rate between the two group with SPSS 20.0.
1-2year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate
Time Frame: 1-2 year
Clinical pregnancy means pregnancy sac is seen intrauterine under ultrasound 7 weeks after embryo transferred. Clinical pregnancy rate(%): number of clinical pregnancy/transferred cycle.Compare the clinical pregnancy rate between the two group with SPSS 20.0.
1-2 year
number of oocytes retrieved
Time Frame: 1-2 year
Compare the number of oocytes retrieved between the two group with SPSS 20.0.
1-2 year
fertility rate
Time Frame: 1-2 year
Fertility rate(%): number of occyte fertilized/ number of oocytes retrieved. Compare the fertility rate between the two group with SPSS 20.0.
1-2 year
normal fertility rate
Time Frame: 1-2 year
Normal fertility rate(%): number of occyte normally fertilized/ number of oocytes retrieved. Compare the normal fertility rate between the two group with SPSS 20.0.
1-2 year
transferable embryo rate
Time Frame: 1-2 year
Cleavage embryo grades 1 or 2 with at least 5 blastomeres are considered as transferrable embryo.Transferable embryo rate(%): number of transferable embryo/number of feritilized oocytes. Compare the transferable embryo rate between the two group with SPSS 20.0.
1-2 year
good quality embryo rate
Time Frame: 1-2 year
Cleavage embryo grades 1 or 2 with 6-10 blastomeres were considered good quality embryos. Good quality embryo rate(%): number of good quality embryo/number of feritilized oocytes.Compare the good quality embryo rate between the two group with SPSS 20.0.
1-2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Director: Xing Yang, M.D. & Ph.D., The Sixth Affiliated Hospital,Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2017

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 19, 2017

First Posted (Estimate)

January 23, 2017

Study Record Updates

Last Update Posted (Estimate)

January 23, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • newivf20170110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Low Ovarian Reserve

Clinical Trials on Growth Hormone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe