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

Primary Purpose

Polycystic Ovary Syndrome, Infertility, Ovulation Disorder

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Gonadorelin

Clomiphene

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

24 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

PCOS was not diagnosed.
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;
Other serious organic heart diseases, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, NYHA cardiac function grade (> III);
Kallmann syndrome, secondary hypogonadotropic hypogonadism, acquired central nervous system diseases, infertility caused by hypothalamic amenorrhea and other secondary infertility;
Has a history of abuse of active substances, including alcohol and a history of alcohol related diseases in the past 2 years.
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;
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;
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.
Pregnancy;
GnRH stimulation test confirmed pituitary and ovarian reserve dysfunction.
Abnormal chromosome detection.
Patients who are allergic to drugs with similar chemical structure.

Sites / Locations

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Pulsatile Gonadotropin-releasing Hormone

Clomiphene

Arm Description

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.

Use Clomiphene for 3 months to treat PCOS

Outcomes

Primary Outcome Measures

Number of participants with ovulation recovery (according to basal body temperature, progesterone levels on cycle day 21, or ultrasonography)

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

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

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

Full Information

NCT ID

NCT03989024

First Posted

May 30, 2019

Last Updated

June 15, 2019

Sponsor

RenJi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03989024

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2019 (Anticipated)

Primary Completion Date

December 30, 2020 (Anticipated)

Study Completion Date

December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RenJi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome, Infertility, Ovulation Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pulsatile Gonadotropin-releasing Hormone

Arm Type

Experimental

Arm Description

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.

Arm Title

Clomiphene

Arm Type

Experimental

Arm Description

Use Clomiphene for 3 months to treat PCOS

Intervention Type

Drug

Intervention Name(s)

Gonadorelin

Intervention Description

Drug: Gonadotropin-releasing Hormone. Generic name: Gonadorelin. Dosage form: 600ug. Dosage: 10ug/puls. Frequency: every 90 min. Duration: 3 months

Intervention Type

Drug

Intervention Name(s)

Clomiphene

Intervention Description

Drug: Clomiphene. Generic name: Clomiphene. Dosage form: 50mg. Dosage: 50mg. Frequency: once a day. Duration: 3 months

Primary Outcome Measure Information:

Title

Number of participants with ovulation recovery (according to basal body temperature, progesterone levels on cycle day 21, or ultrasonography)

Description

Number of participants with ovulation recovery (according to basal body temperature, progesterone levels on cycle day 21, or ultrasonography) after use of drugs

Time Frame

up to 12 weeks

Secondary Outcome Measure Information:

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Description

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

Time Frame

up to 12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

24 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: PCOS of childbearing age (24-45 years old); non-obesity; After 6 months of metformin (at least 1000-1500 mg/d) intervention, the normal menstrual cycle was still not restored. No drug intervention except metformin was used in last 3 monthes: There is a pregnancy plan within 1 years. The pregnancy test was negative. Heart and liver function is normal, thyroid function is normal, adrenal function is normal. The GnRH stimulation test confirmed that the pituitary and ovarian reserve function was good. Chromosome examination is normal. Did not take part in other clinical trials. Exclusion Criteria: PCOS was not diagnosed. 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; Other serious organic heart diseases, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, NYHA cardiac function grade (> III); Kallmann syndrome, secondary hypogonadotropic hypogonadism, acquired central nervous system diseases, infertility caused by hypothalamic amenorrhea and other secondary infertility; Has a history of abuse of active substances, including alcohol and a history of alcohol related diseases in the past 2 years. 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; 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; 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. Pregnancy; GnRH stimulation test confirmed pituitary and ovarian reserve dysfunction. Abnormal chromosome detection. Patients who are allergic to drugs with similar chemical structure.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tao TAO, MD

Phone

+86-13817701776

taotaozhen@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

TAO TAO, DM

Organizational Affiliation

RenJi Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

City

Shanghai

ZIP/Postal Code

200127

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tao Tao, Doctor

Phone

+86-13817701776

taotaozhen@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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