Status:

UNKNOWN

LOD vs Gn in Anovulatory PCOs Resistant to First Line Agents

Lead Sponsor:

Assiut University

Conditions:

Polycystic Ovary Syndrome

Anovulation

Eligibility:

FEMALE

18-40 years

Phase:

NA

Brief Summary

PCOS is a complex disease that is diagnosed by the presence of two of the following three: oligo/anovulation, clinical and/or biochemical hyperandrogenism, or polycystic ovaries by ultrasound . PCOS a...

Detailed Description

PCOS is a complex disease that is diagnosed by the presence of two of the following three: oligo/anovulation, clinical and/or biochemical hyperandrogenism, or polycystic ovaries by ultrasound . PCOS a...

Eligibility Criteria

Inclusion

  • anovulatory polycystic ovary syndrome resistant to first line ovulation induction.
  • Polycystic ovary Syndrome defined by Rotterdam's criteria 2003
  • Clomiphene resistance defined as failure to ovulate with a dose of 150mg per day for 5 days for 3 cycles
  • Letrozole resistance defined as failure to ovulate with a dose of 7.5 mg per day for 5 days for 3 cycles

Exclusion

  • women's age \< 18 years or ≥ 40 years.
  • BMI \> 40 kg/m2
  • Patient with hyperprolactinaemia (serum prolactin above normal limits)
  • Patients with hypogonadotropic hypogonadism (low serum FSH and LH)
  • Patients with anovulation due to ovarian failure (serum FSH higher than normal limits)
  • Male infertility
  • Tubal abnormality, Known endometriosis, adenomyosis, uterine myomas or any other detected cause of female infertility
  • History of ovarian surgery as laparoscopic ovarian drilling, ovarian cystectomy or oophorectomy
  • History of pelvic radiation
  • Patient recently treated with any type of induction of ovulation in the last three months.

Key Trial Info

Start Date :

December 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2022

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT04325295

Start Date

December 1 2020

End Date

August 1 2022

Last Update

October 14 2020

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