NCT02801591

Brief Summary

Observe the clinical efficacy and safety of Recombinant Human Growth Hormone Injection assisted in the treatment of the patients with poor ovarian response in vitro fertilization and embryo transfer.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 16, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Last Updated

June 16, 2016

Status Verified

June 1, 2016

Enrollment Period

1 year

First QC Date

June 6, 2016

Last Update Submit

June 12, 2016

Conditions

Poor Ovarian Response

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    One year

Secondary Outcomes (3)

  • Number of retrieved oocytes

    One year

  • Number of high quality embryos

    One year

  • Number of embryos transferred

    One year

Study Arms (1)

GH AQ

Procedure: Conventional ovarian stimulation proctol without rhGH

Interventions

Conventional ovarian stimulation proctol without rhGHPROCEDURE
GH AQ

Eligibility Criteria

Age30 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Poor ovarian response

You may qualify if:

  • Female, age 30-42 years old.
  • Diagnosis of POR (2011 ESHRE Bologna Standard).
  • At least two previous IVF failure history.
  • Voluntarily to sign the "informed consent".

You may not qualify if:

  • Severe acute and chronic liver and kidney disease，Such as liver cirrhosis, acute and chronic renal failure, hepatitis B virus activity period, etc.；Liver and kidney dysfunction.
  • Endocrine and metabolic diseases，eg, diabetes、Thyroid function hyperthyroidism, Thyroid dysfunction, cushing's syndrome, hyperprolactinemia，hyperandrogenism.
  • Related diseases affecting outcome of IVF pregnancy，eg, hydrosalpinx, hysteromyoma≥4cm, adenomyosis, stage III and IV endometriosis, untreated endometrial lesions, uterine malformation, genital tuberculosis, malignant tumor of reproductive system （include endometrial carcinoma, cervical carcinoma, ovarian cancer, fallopian tube carcinoma）.
  • Allergic to E. coli expression product and its excipients.
  • Subjects who participated in the past three months or are participating in other drug clinical researchers.
  • IVF failure history≥3.
  • The researchers consider who is not suitable for enrolling the group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University Third Hospital

Beijing, China

RECRUITING

People's Hospital of Peking University

Beijing, China

NOT YET RECRUITING

Study Officials

  • Xin Na Chen

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui Yang

CONTACT

010-82265080

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 16, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2017

Last Updated

June 16, 2016

Record last verified: 2016-06

Locations

CN(2)