Combined Chromium With Letrozole Versus Letrozole Only in Induction of Ovulation in Patients With Polycystic Ovary Syndrome

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05765305
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Actual Duration (Months): 13
• Patients Per Site Per Month: 6.9

Study Details

Study Description

Brief Summary

Combined letrozole with chromium versus letrozole only in induction of ovulation in polycystic ovary syndrome

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: Letrozole with chromium

Detailed Description

Randomized controlled trial

Study Design

• Study Type: Observational
• Actual Enrollment: 90 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Letrozole and Chromium
• Actual Study Start Date: Sep 1, 2018
• Actual Primary Completion Date: Oct 1, 2019
• Actual Study Completion Date: Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Letrozole Letrozole versus letrozole with chromium	Drug: Letrozole with chromium; Letrozole versus letrozole with chromium

Outcome Measures

Primary Outcome Measures

1. Efficacy of letrozole [12 months]

   efficacy of letrozole with chromium in improving induction of ovulation

Secondary Outcome Measures

1. Miscarriage rate [12 months]

   Incidence of OHSS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• female patients aged from 18 to 35 years Anovulatory cycles Pcos

Exclusion Criteria:

• female patients aged more than 35years Male factor of infertility Other factors of infertility than pcos

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine	Cairo	القاهره	Egypt

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammed salah Nasr, Clinical professor, Cairo University
• ClinicalTrials.gov Identifier: NCT05765305
• Other Study ID Numbers: 505
• First Posted: Mar 13, 2023
• Last Update Posted: Mar 15, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Syndrome; Chromium; Letrozole

Study Results

No Results Posted as of Mar 15, 2023