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出境医 / 临床实验 / Pulsatile Gonadotropin-releasing Hormone for Infertility in Non-obese Patients With Polycystic Ovary Syndrome

Pulsatile Gonadotropin-releasing Hormone for Infertility in Non-obese Patients With Polycystic Ovary Syndrome

Study Description
Brief Summary:
Polycystic ovary syndrome (PCOS) patients are often accompanied by infertility. Non-obese PCOS infertility is more difficult to treat than obese PCOS. The study included non-obese PCOS patients who had not recovered from regular menstruation after six months of metformin treatment. Half of the patients were treated with clomiphene for ovulation induction and half with GnRH pulse therapy.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Infertility Ovulation Disorder Drug: Gonadorelin Drug: Clomiphene Phase 4

Detailed Description:
To investigate whether GnRH pulse therapy of non-obese PCOS women can improve ovulation rate.The investigators plan to recruit non-obese PCOS women with abnormal GnRH pulse mode not effective of metformin treatment at childbearing age. By using GnRH pulse therapy and Clomiphene therapy. the investigators will intervent the participants for 3 months and to compare outcome in each group.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pulsatile Gonadotropin-releasing Hormone for Infertility in Non-obese Patients With Polycystic Ovary Syndrome
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Pulsatile Gonadotropin-releasing Hormone
Drug: Gonadorelin. Use Gonadorelin for 3 months to treat PCOS. The pulse was administered with a hormone pump, once every 90 min, and 10ug per pulse.
 Drug: Gonadorelin
Drug: Gonadotropin-releasing Hormone. Generic name: Gonadorelin. Dosage form: 600ug. Dosage: 10ug/puls. Frequency: every 90 min. Duration: 3 months
Experimental: Clomiphene
Use Clomiphene for 3 months to treat PCOS
 Drug: Clomiphene
Drug: Clomiphene. Generic name: Clomiphene. Dosage form: 50mg. Dosage: 50mg. Frequency: once a day. Duration: 3 months
Outcome Measures
Primary Outcome Measures :
  1. Number of participants with ovulation recovery (according to basal body temperature, progesterone levels on cycle day 21, or ultrasonography) [ Time Frame: up to 12 weeks ]
    Number of participants with ovulation recovery (according to basal body temperature, progesterone levels on cycle day 21, or ultrasonography) after use of drugs


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: up to 12 weeks ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. Evaluation of efficacy and safety of short-term GnRH pulse therapy for non obese PCOS


Eligibility Criteria
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Ages Eligible for Study:   24 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. PCOS of childbearing age (24-45 years old);
  2. non-obesity;
  3. After 6 months of metformin (at least 1000-1500 mg/d) intervention, the normal menstrual cycle was still not restored.
  4. No drug intervention except metformin was used in last 3 monthes:
  5. There is a pregnancy plan within 1 years.
  6. The pregnancy test was negative.
  7. Heart and liver function is normal, thyroid function is normal, adrenal function is normal.
  8. The GnRH stimulation test confirmed that the pituitary and ovarian reserve function was good.
  9. Chromosome examination is normal.
  10. Did not take part in other clinical trials.

Exclusion Criteria:

  1. PCOS was not diagnosed.
  2. Severe liver and kidney dysfunction (ALT is 2.5 times greater than normal upper limit, or Cr > 132 umol/l, or eGFR < 60 mL/min/1.73 m2), thyroid dysfunction, adrenal dysfunction, psychosis, severe infection, severe anemia, neutropenia;
  3. Other serious organic heart diseases, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, NYHA cardiac function grade (> III);
  4. Kallmann syndrome, secondary hypogonadotropic hypogonadism, acquired central nervous system diseases, infertility caused by hypothalamic amenorrhea and other secondary infertility;
  5. Has a history of abuse of active substances, including alcohol and a history of alcohol related diseases in the past 2 years.
  6. Previous history of central nervous system and gonad-related surgery, or other central nervous system and gonad-related surgery (such as central nervous system tumor resection, ovarian chocolate cyst resection) within one year, or other non-central nervous system and gonad surgery within six months;
  7. In the past five years, there have been organ system tumors (except for local cutaneous basal cell carcinomas) that have been treated or not treated, regardless of whether there is evidence of local recurrence or metastasis;
  8. Hypoglycemic drugs, contraceptives (Dain, Marvelon), ovulation-promoting drugs (clomiphene, letrozole), emergency contraceptives and sex hormone drugs have been or are being used to adjust menstrual cycle and promote ovulation except metformin.
  9. Pregnancy;
  10. GnRH stimulation test confirmed pituitary and ovarian reserve dysfunction.
  11. Abnormal chromosome detection.
  12. Patients who are allergic to drugs with similar chemical structure.
Contacts and Locations

Contacts
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Contact: Tao TAO, MD +86-13817701776 taotaozhen@hotmail.com

Locations
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China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China, 200127
Contact: Tao Tao, Doctor    +86-13817701776    taotaozhen@hotmail.com   
Sponsors and Collaborators
RenJi Hospital
Investigators
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Principal Investigator: TAO TAO, DM RenJi Hospital
Tracking Information
First Submitted Date  ICMJE May 30, 2019
First Posted Date  ICMJE June 18, 2019
Last Update Posted Date June 18, 2019
Estimated Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2019) 		Number of participants with ovulation recovery (according to basal body temperature, progesterone levels on cycle day 21, or ultrasonography) [ Time Frame: up to 12 weeks ]
Number of participants with ovulation recovery (according to basal body temperature, progesterone levels on cycle day 21, or ultrasonography) after use of drugs
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2019) 		Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: up to 12 weeks ]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. Evaluation of efficacy and safety of short-term GnRH pulse therapy for non obese PCOS
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pulsatile Gonadotropin-releasing Hormone for Infertility in Non-obese Patients With Polycystic Ovary Syndrome
Official Title  ICMJE Pulsatile Gonadotropin-releasing Hormone for Infertility in Non-obese Patients With Polycystic Ovary Syndrome
Brief Summary Polycystic ovary syndrome (PCOS) patients are often accompanied by infertility. Non-obese PCOS infertility is more difficult to treat than obese PCOS. The study included non-obese PCOS patients who had not recovered from regular menstruation after six months of metformin treatment. Half of the patients were treated with clomiphene for ovulation induction and half with GnRH pulse therapy.
Detailed Description To investigate whether GnRH pulse therapy of non-obese PCOS women can improve ovulation rate.The investigators plan to recruit non-obese PCOS women with abnormal GnRH pulse mode not effective of metformin treatment at childbearing age. By using GnRH pulse therapy and Clomiphene therapy. the investigators will intervent the participants for 3 months and to compare outcome in each group.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Polycystic Ovary Syndrome
  • Infertility
  • Ovulation Disorder
Intervention  ICMJE
  • Drug: Gonadorelin
    Drug: Gonadotropin-releasing Hormone. Generic name: Gonadorelin. Dosage form: 600ug. Dosage: 10ug/puls. Frequency: every 90 min. Duration: 3 months
  • Drug: Clomiphene
    Drug: Clomiphene. Generic name: Clomiphene. Dosage form: 50mg. Dosage: 50mg. Frequency: once a day. Duration: 3 months
Study Arms  ICMJE
  • Experimental: Pulsatile Gonadotropin-releasing Hormone
    Drug: Gonadorelin. Use Gonadorelin for 3 months to treat PCOS. The pulse was administered with a hormone pump, once every 90 min, and 10ug per pulse.
    Intervention: Drug: Gonadorelin
  • Experimental: Clomiphene
    Use Clomiphene for 3 months to treat PCOS
    Intervention: Drug: Clomiphene
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 15, 2019) 		78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. PCOS of childbearing age (24-45 years old);
  2. non-obesity;
  3. After 6 months of metformin (at least 1000-1500 mg/d) intervention, the normal menstrual cycle was still not restored.
  4. No drug intervention except metformin was used in last 3 monthes:
  5. There is a pregnancy plan within 1 years.
  6. The pregnancy test was negative.
  7. Heart and liver function is normal, thyroid function is normal, adrenal function is normal.
  8. The GnRH stimulation test confirmed that the pituitary and ovarian reserve function was good.
  9. Chromosome examination is normal.
  10. Did not take part in other clinical trials.

Exclusion Criteria:

  1. PCOS was not diagnosed.
  2. Severe liver and kidney dysfunction (ALT is 2.5 times greater than normal upper limit, or Cr > 132 umol/l, or eGFR < 60 mL/min/1.73 m2), thyroid dysfunction, adrenal dysfunction, psychosis, severe infection, severe anemia, neutropenia;
  3. Other serious organic heart diseases, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, NYHA cardiac function grade (> III);
  4. Kallmann syndrome, secondary hypogonadotropic hypogonadism, acquired central nervous system diseases, infertility caused by hypothalamic amenorrhea and other secondary infertility;
  5. Has a history of abuse of active substances, including alcohol and a history of alcohol related diseases in the past 2 years.
  6. Previous history of central nervous system and gonad-related surgery, or other central nervous system and gonad-related surgery (such as central nervous system tumor resection, ovarian chocolate cyst resection) within one year, or other non-central nervous system and gonad surgery within six months;
  7. In the past five years, there have been organ system tumors (except for local cutaneous basal cell carcinomas) that have been treated or not treated, regardless of whether there is evidence of local recurrence or metastasis;
  8. Hypoglycemic drugs, contraceptives (Dain, Marvelon), ovulation-promoting drugs (clomiphene, letrozole), emergency contraceptives and sex hormone drugs have been or are being used to adjust menstrual cycle and promote ovulation except metformin.
  9. Pregnancy;
  10. GnRH stimulation test confirmed pituitary and ovarian reserve dysfunction.
  11. Abnormal chromosome detection.
  12. Patients who are allergic to drugs with similar chemical structure.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 24 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tao TAO, MD +86-13817701776 taotaozhen@hotmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03989024
Other Study ID Numbers  ICMJE 18411968700
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party RenJi Hospital
Study Sponsor  ICMJE RenJi Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: TAO TAO, DM RenJi Hospital
PRS Account RenJi Hospital
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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