Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate

NCT03674385 | Completed Phase 2

• 1 other identifier: PHCL 191
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluate the addition of Vit E to clomiphene citrate in the treatment of poly cystic ovary.Half the patients will receive both Vit E and clomiphene citrate the other half will receive clomiphene citrate only.

Conditions

Clomiphene Citrate Resistant Polycystic Ovary Syndrome

Keywords

Vitamin E; Polycystic ovary

Outcome Measures

Primary Outcomes (1)

• ovulation rate

  Follicles measure more than 18 mm will be considered mature follicles.

  3 months

Study Arms (2)

vitamin E group

EXPERIMENTAL

30 patient

Dietary Supplement: vitamin E; Drug: Metformin; Drug: Clomiphene Citrate

control group

ACTIVE COMPARATOR

clomiphene

Drug: Metformin; Drug: Clomiphene Citrate

Interventions

vitamin E DIETARY_SUPPLEMENT

Vitamin E is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect

Also known as: toco 1000

vitamin E group

Metformin DRUG

Metformin is in the biguanide class. It works by decreasing glucose production by the liver and increasing the insulin sensitivity of body tissues. It is also used in the treatment of polycystic ovary syndrome (PCOS)

Also known as: cidophage

control group; vitamin E group

Clomiphene Citrate DRUG

is a medication used to treat infertility in women who do not ovulate

Also known as: clomid

control group; vitamin E group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients will be diagnosed as having PCOS according to the Rotterdam criteria for diagnosis of PCOS
• Age between 18 and 39 years.
• Period of infertility \>1 years.
• No treatment taken during the last 2 months.
• Patients who have previously received clomiphene citrate (CC) and being diagnosed as having CC resistance

You may not qualify if:

• History of pelvic surgery or infertility factor other than anovulation
• Endocrine disorders in the form of hypothyroidism or hyperthyroidism, hyperprolactinemia, and Cushing syndrome, as detected by history, examination, or investigations.
• Known cases of endometriosis (approved histologically), uterine anomaly or hydrosalpinx, retinitis pigmentosa and vitamin K deficiency.
• Consumption of vitamin and antioxidant supplementations in the last three-months before the trial start date.
• Male factor infertility (sperm count \< 5 million per milliliter, normal morphology \<4%).
• Elevated serum prolactin, T.S.H and F.S.H.
• Patients diagnosed with diabetes mellitus

Sponsors & Collaborators

• Ain Shams University: lead
• Misr University for Science and Technology: collaborator

Study Sites (1)

Medical Center of Infertility

Banī Suwayf, 62521, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Vitamin E; Metformin; Clomiphene

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Biguanides; Guanidines; Amidines; Organic Chemicals; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pharmacist

Model Details: prospective randomized controlled open label study

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: September 17, 2018
• Study Start: July 19, 2018
• Primary Completion: March 25, 2019
• Study Completion: March 30, 2019
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)