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Trial record 6 of 16 for:    "Ovarian Cyst" | "Testosterone"

Ovulation Induction in Clomiphene Citrate Resistant PCO Women

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ClinicalTrials.gov Identifier: NCT02341703
Recruitment Status : Completed
First Posted : January 19, 2015
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Ghada Abdel Fattah, Cairo University

Brief Summary:
Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this study we will compare the effect of combined letrozole-metformin with that of combined letrozole-pioglitazone in ovulation induction in CC-resistant PCOS women

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Infertility Drug: letrozole-metformin Drug: letrozole-metformin-pioglitazone Radiation: transvaginal ultrasound Other: laboratory investigations Early Phase 1

Detailed Description:

Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the ACOG recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS. CC has a long half-life (2 weeks), and this may have a negative effect on the cervical mucus and endometrium, leading to discrepancy between ovulation and conception rates. There has been a search for a compound capable of inducing ovulation but devoid of the adverse antiestrogenic effects of CC. recent studies have suggested that letrozole, an aromatase inhibitor, does not possess the adverse antiestrogenic effects of CC and is associated with higher pregnancy rates than CC treatment in patients with PCOS.

In this study the investigators shall compare the effect of combined letrozole-metformin with that of combined letrozole-metformin-pioglitazone in ovulation induction in CC-resistant PCOS women.This will be a prospective comparative clinical trial in which 2 groups of women will be generated (groups A and B) using the sealed envelopes randomization method.Group A (50 women) will receive: letrozole 2.5 mg/day from 3rd day of the cycle for 5 days and (pioglitazone 15 mg + metformin 850 mg) once daily from 1st day of the cycle for 10 days. Group B (50 women) will receive letrozole 2.5 mg/day from 3rd day of the cycle for 5 days and metformin 500 mg three times daily from continuously untill pregncy occurrs. Ovulation will be monitored by vaginal ultrasound and serum estrogen and progesterone.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Letrozole-metformin Versus Letrozole-metformin-pioglitazone in PCO Clomiphene Citrate Resistant Women
Study Start Date : February 2015
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015


Arm Intervention/treatment
Active Comparator: letrozole-metformin group

this group will receive letrozole 2.5 mg daily from day 3 of the cycle and for 5 days + metformin 500 mg three times daily from the first day of the cycle and continuous for three months unless pregnancy occurred. treatment will continue for 3 cycles unless pregnancy occurred.

for this group: transvaginal ultrasound will monitor follicular enlargement laboratory investigations in the form of day 3 FSH, LH, TSH and serum testosterone will be done day 12 E2 day 21 serum progesterone

Drug: letrozole-metformin
letrozole 2.5 mg will be given daily from day 3 of the cycle for 5 days + metformin 500 mg three times daily continuously for 3 months unless pregnancy occurred
Other Name: femara-cidophage

Radiation: transvaginal ultrasound
transvaginal ultrasound will be done from day 10 of the cycle and every other day for monitoring of follicular enlargement.

Other: laboratory investigations
day 3: FSH, LH, TSH, and total testosterone day 12 serum E2 day 21 serum progesterone

Active Comparator: letrozole-metformin-pioglitazone group

this group will receive letrozole 2.5 mg daily from day 3 of the cycle and for 5 days + (metformin 850 mg + pioglitazone 15 mg) once daily from the first day of the cycle and for 10 days. treatment will continue for 3 cycles unless pregnancy occurred.

for this group: transvaginal ultrasound will monitor follicular enlargement laboratory investigations in the form of day 3 FSH, LH, TSH and serum testosterone will be done day 12 E2 day 21 serum progesterone

Drug: letrozole-metformin-pioglitazone
letrozole will be given daily from day 3 of the cycle for 5 days + (metformin 850 mg + pioglitazone 15 mg) from the first day of the cycle for 10 days.
Other Name: femara- bioglita plus

Radiation: transvaginal ultrasound
transvaginal ultrasound will be done from day 10 of the cycle and every other day for monitoring of follicular enlargement.

Other: laboratory investigations
day 3: FSH, LH, TSH, and total testosterone day 12 serum E2 day 21 serum progesterone




Primary Outcome Measures :
  1. ovulation rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. pregnancy rate [ Time Frame: 6 months ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20-40 years old
  • PCOS infertile women resistant to CC for 3 cycles

Exclusion Criteria:

  • Presence of medical disorders as diabetes, hypertension, cardiac problems, liver or kidney diseases, hyperprolactinemia or thyroid dysfunction
  • Use of gonadotropins before
  • Previous ovarian drilling
  • Presence of urinary symptoms especially bloody urine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02341703


Locations
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Egypt
faculty of medicine, Cairo University
Cairo, Egypt, 002
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ghada Abdel Fattah Abdel Moety, lecturer Cairo University

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Responsible Party: Ghada Abdel Fattah, assistant professor of Obstetrics and Gynecology, Cairo University
ClinicalTrials.gov Identifier: NCT02341703     History of Changes
Other Study ID Numbers: University Hospital
First Posted: January 19, 2015    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Ovarian Cysts
Testosterone
Polycystic Ovary Syndrome
Infertility
Genital Diseases, Male
Genital Diseases, Female
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Metformin
Pioglitazone
Letrozole
Clomiphene
Enclomiphene
Zuclomiphene
Progesterone
Hypoglycemic Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents
Progestins
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors