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Trial · Interventional

Status unknownPhase 4Registry data

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

NCTNCT03989024 (opens ClinicalTrials.gov in a new tab)Other id18411968700
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
78 participants (estimated)
Sponsor
RenJi Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
1 Jul 2019 (estimated)
Primary completion
30 Dec 2020 (estimated)
Completion
30 Dec 2021 (estimated)
First posted
18 Jun 2019
Last update posted
18 Jun 2019
Conditions
Polycystic Ovary Syndrome · Infertility · Ovulation Disorder

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2019202020212022
  1. Ph 4

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

    NCT03989024

    est. 1 Jul 2019 to est. 30 Dec 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • GonadorelinDrug
  • ClomipheneDrug

Arms2

  • 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.

  • Experimental

    Clomiphene

    Use Clomiphene for 3 months to treat PCOS

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Registry description

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

Secondary outcomes(1)

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

    Time frame · up to 12 weeks

    Registry 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 24 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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