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Status unknownNCT02801565Updated Nov 28, 2016

Clinical Observation of Recombinant Human Growth Hormone Injection Assisted IVF-ET in the Treatment of PCOS

An interventional study of Conventional controlled ovarian stimulation proctol in Polycystic Ovary Syndrome, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Status unknown at 1 site in China. Open to female participants aged 25 Years to 35 Years. Per ClinicalTrials.gov, last updated 2016-11-28.

Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
208
Allocation
Not applicable
Ages
25 Years to 35 Years
Sex
Female
01

Study summary

Observe validity of Recombinant Human Growth Hormone Injection assisted in IVF-ET (in vitro fertilization and embryo transfer) treatment of PCOS (polycystic ovary syndrome) patients.

02

Conditions studied

  • Polycystic Ovary Syndrome
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 175 are open to participants now.

This study's planned enrollment of 208 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Changchun GeneScience Pharmaceutical Co., Ltd. is the lead sponsor of 108 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Age between 25 and 35 years old, married female and infertile.
  • BMI≥25kg/m2.
  • Diagnosed as PCOS.
  • No obvious chronic organic diseases, such as liver, kidney, heart, lung, thyroid, adrenal disease.
  • Subjects do not take part in other clinical trial study within 3 months.
  • The subjects sign the informed consent form.

Exclusion criteria

Exclusion Criteria:

  • BMI\<25kg/m2.
  • Hyperprolactinemia and congenital adrenal cortical hyperplasia.
  • Diabetes, thyroid function hyperthyroidism, thyroid dysfunction, cushing's syndrome.
  • Pelvic and peritoneal tumor and tumor secreting hyperandrogenism.
  • Severe acute and chronic liver and kidney disease, such as liver cirrhosis, acute and chronic renal failure, hepatitis B virus activity.
  • Liver and kidney dysfunction, AST/ALT is 2.5 times higher than the normal limit, the serum of creatinine is 2 times higher than the normal level.
  • Diseases affecting outcome of IVF pregnancy, eg, hydrosalpinx, hysteromyoma>4 cm, adenomyosis, endometriosis, endometrial cyst of ovary, unilateral ovary, tuberculosis of reproductive system.
  • Allergic to E. coli. expression product and its excipients.
  • Being involved in other drug clinical researchers.
  • The researchers consider who is not suitable for the group.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
208 participants (estimated)

Study arms

  • Experimental
    GH AQ

    Controlled ovarian stimulation in the middle of the corpus (D21 days) of the previous menstrual cycle to use recombinant Human Growth Hormone Injection（rhGH） Injection 15IU/5mg/3mL/cartridge, 5IU per day, Subcutaneous injection after 20:00 until the HCG trigger day.

    Drug: Conventional controlled ovarian stimulation proctol

Interventions

  • DrugConventional controlled ovarian stimulation proctol

    Conventional controlled ovarian stimulation proctol without rhGH.

06

What researchers measure

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: One year

  2. Number of fertilized oocytes

    Time frame: One year

Secondary outcomes

  1. Number of retrieved oocytes

    Time frame: One year

  2. Number of high quality embryos

    Time frame: One year

  3. Number of transferred embryos

    Time frame: One year

07

Study locations

1 of 1 sites recruiting
  • Peking University Third Hospital
    Beijing, China
    • Ying Wang · Contact · 010-82265080
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02801565
Lead sponsor
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborators
Peking University Third Hospital
Responsible party
Sponsor
First posted
Jun 16, 2016
Start date
Feb 2016
Primary completion
Feb 2017 (estimated)
Last update
Nov 28, 2016

Study contacts

Shuo Huang
Contact
homelyleaf@aliyun.cn
010-82265080
Ying Wang
principal investigator · Peking University Third Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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