Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Gland and Hormone Related Diseases

Syndrome

Infertility

Polycystic Ovary Syndrome

Genital Diseases

Urogenital Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

All Drugs and Chemicals

Reproductive Control Agents

Hormones

Prolactin Release-Inhibiting Factors

Clomiphene

Enclomiphene

Zuclomiphene

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

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

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

Gonadorelin

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

Tao TAO, MD

Tao Tao, Doctor

TAO TAO, DM

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.

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.

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

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

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

RenJi Hospital

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Rare Diseases

Hyperandrogenism

Disorders of Sex Development

46, XX Disorders of Sex Development

Congenital Abnormalities

Urogenital Abnormalities

Adrenal Hyperplasia, Congenital

Adrenogenital Syndrome

Male Urogenital Diseases

Congenital Adrenal Hyperplasia

21-hydroxylase Deficiency

Natriuretic Agents

Androgens

Spironolactone

Mineralocorticoid Receptor Antagonists

Mineralocorticoids

Diuretics

Diuretics, Potassium Sparing

16 weeks without medication, then 16 weeks with medication, then 12 months without medication; spironolactone 50 mg tablets: 50-100 mg orally twice daily (1.7-3.3 mg/kg/24 hr)

Spironolactone is an androgen-receptor commonly used (off-label) for hyperandrogenism in girls and women. It is used in this study to determine if androgen blockade can improve ovulation rates in girls with androgen excess, who often have low rates of ovulation in the years following menarche. The spironolactone dose will be as follows: If ≤ 60 kg, 50 mg twice daily; if \> 60 kg, 100 mg twice daily.

Melissa Gilrain, BS

Christine Burt Solorzano, MD

Melissa Gilrain

Adolescent girls with androgen excess have a higher rate of irregular periods and decreased ovulation rates compared to normal girls, and are considered at-risk for developing polycystic ovary syndrome (PCOS). This pilot study will look at whether giving spironolactone might improve ovulation rates in girls with androgen excess, ages 13-19. If this is true, spironolactone treatment to young girls might prevent PCOS from developing and avoid future infertility.

This is a non-randomized, clinical pilot study testing whether 16 weeks of spironolactone improves ovulation rates in post-menarcheal girls with androgen excess. The investigators will recruit girls ages 13-19 with clinical or biochemical androgen excess (defined as hirsutism and/or elevated Tanner stage-specific free testosterone concentrations) who are 4 to 6 years post-menarche. Girls will keep a menstrual diary and collect twice weekly saliva samples for progesterone and estradiol for 16 weeks before and for 16 weeks during spironolactone (if ≤ 60 kg, 50 mg twice daily; if \> 60 kg, 100 mg twice daily \[1.7-3.3 mg/kg/24 hr\]) use. Girls will be asked to continue to collect saliva twice weekly for progesterone and estradiol testing for an additional 16 weeks after discontinuation of spironolactone and to continue menstrual diaries off of study medication for 12 additional months to assess persistence of any spironolactone effect. Ovulation events will be counted per 100 days based on definitive rises in salivary progesterone. The primary outcome will be changes in ovulation rate during spironolactone use compared to baseline. Changes in menstrual regularity via inter-menstrual interval will also be assessed as a secondary outcome of spironolactone administration. Another secondary outcome will be changes in acne and/or hirsutism.

non-randomized cross-sectional, before and after intervention

Does Treatment of Androgen Excess Using Spironolactone Improve Ovulatory Rates in Girls With Androgen Excess?

Ovulation rate during and after spironolactone compared to before medication. Ovulation will be counted based on salivary progesterone levels. The rate of ovulation will be defined as the number of ovulatory cycles per 100 days of follow-up.

Menstrual length during and after spironolactone compared to before medication. Changes in menstrual regularity will be assessed using inter-menstrual interval (IMI)

Changes in acne before vs. after spironolactone treatment assessed using the Global Acne Grading System

Changes in hirsutism before vs. after spironolactone assessed using a modified Ferriman-Gallwey scoring system

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pulsatile Gonadotropin-releasing Hormone for Infertility in Non-obese Patients With Polycystic Ovary Syndrome	NCT03989024	Polycystic Ovar... Infertility Ovulation Disor...	Gonadorelin Clomiphene	24 Years - 45 Years	RenJi Hospital
Does Treatment of Androgen Excess Using Spironolactone Improve Ovulatory Rates in Girls With Androgen Excess?	NCT04075149	Polycystic Ovar... Puberty Disorde... Ovulation Disor...	Spironolactone	13 Years - 19 Years	University of Virginia
Does Treatment of Androgen Excess Using Spironolactone Improve Ovulatory Rates in Girls With Androgen Excess?	NCT04075149	Polycystic Ovar... Puberty Disorde... Ovulation Disor...	Spironolactone	13 Years - 19 Years	University of Virginia

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