The Effect Of Vitamin D Replacement Therapy On Serum Leptin And Follicular Growth Pattern In Women With Resistant Polycystic Ovary

NCT03806036 | Unknown Phase 4 DMC

• 1 other identifier: 47
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study included 100 female diagnosed with polycystic ovary syndrome. They were classified into 2 groups: Study group included 50 women will receive 300.000 I.U single dose of Vitamin D intramuscular injection (Memphis company) , and in the next menstrual cycle induction done by clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day . Control group included 50 women will receive only clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day. Serum 25 hydroxy Vitamin D3, Serum Leptin and FSH will be done to all women before and after intervention.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• Ovulation

  appearance of dominant follicle 18 - 22 mm in diameter

  14 days after menses

Study Arms (2)

Vitamin D group

ACTIVE COMPARATOR

50 women will receive 300.000 I.U single dose of VIT D IM injection (Memphis company) , and in the next menstrual cycle induction done by clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day

Drug: Vitamin D; Drug: Clomiphene Citrate

Control group

PLACEBO COMPARATOR

50 women will receive clomiphen citrate 100mg daily for 5 days starting from third day of menstruation and HMG single dose on 8th day

Drug: Clomiphene Citrate

Interventions

Vitamin D DRUG

300.000 I.U single dose of VIT D IM injection

Vitamin D group

Clomiphene Citrate DRUG

100mg daily for 5 days starting from third day of menstruation

Also known as: Clomid

Control group; Vitamin D group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI: more than 25.0 kg/m2
• PCO was diagnosed by presence of 2 out of 3 criteria (according to ESHRE/ASRM in Rotterdam in 2003)
• oligoovulation and/or an ovulation
• excess androgen activity (clinical or biochemical)
• polycystic ovaries (by pelvic ultrasound "vaginal route")
• Anovulatory patient resistant to induction with clomiphene citrate alone

You may not qualify if:

• ) BMI: more than 35.0 kg/m2
• \) Infertile women due to any factor other than PCO

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Vitamin D; 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)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ahmed Maged

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+201005227404; prof.ahmedmaged@gmail.com

Wesam Deeb, MD

CONTACT

wessamdeeb74@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 13, 2019
• First Posted: January 16, 2019
• Study Start: January 2, 2018
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

EG (1)