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

NCT03989024 | Unknown Phase 4 FDA Drug

• 1 other identifier: 18411968700
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Infertility; Ovulation Disorder

Outcome Measures

Primary Outcomes (1)

• 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

  up to 12 weeks

Secondary Outcomes (1)

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

  up to 12 weeks

Study Arms (2)

Pulsatile Gonadotropin-releasing Hormone

EXPERIMENTAL

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

Clomiphene

EXPERIMENTAL

Use Clomiphene for 3 months to treat PCOS

Drug: Clomiphene

Interventions

Gonadorelin DRUG

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

Pulsatile Gonadotropin-releasing Hormone

Clomiphene DRUG

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

Clomiphene

Eligibility Criteria

• Age: 24 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, 200127, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility

Interventions

Gonadotropin-Releasing Hormone; Clomiphene

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• TAO TAO, DM

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao TAO, MD

CONTACT

+86-13817701776; taotaozhen@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 18, 2019
• Study Start: July 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2021
• Last Updated: June 18, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)