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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2019-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vitamin D for Polycystic Ovary Syndrome Clomiphene Resistant Women

NCT04010942

PCOS Vitamin D Deficiency

COMPLETED PHASE4

Effect of Vitamin D Supplement in Induction of Ovulation in Overweight Women With Polycystic Ovary Syndrome

NCT03396380

Ovulation Induction

UNKNOWN PHASE3

Is There Association Between Vitamin D Levels And Insulin Resistance In Polycystic Ovary Syndrome?

NCT02803476

Polycystic Ovary Syndrome Insulin Resistance Vitamin D Deficiency

UNKNOWN

Vitamin D Supplementation and Improvement of PCOS Therapy and IVF Outcomes in Infertile Saudi Women

NCT05106712

Female Infertility Polycystic Ovary Syndrome Pathologic Processes +3 more

UNKNOWN NA

Efficacy of Vit E in PCOS Resistant to Clomiphene Citrate

NCT03674385

Clomiphene Citrate Resistant Polycystic Ovary Syndrome

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study included 100 female diagnosed with polycystic ovary syndrome diagnosed by 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) and polycystic ovaries (by pelvic ultrasound "vaginal route").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

See the medical conditions and disease areas that this research is targeting or investigating.

Polycystic Ovary Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vitamin D group

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

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

300.000 I.U single dose of VIT D IM injection

Clomiphene Citrate

Intervention Type DRUG

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

Control group

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

Group Type PLACEBO_COMPARATOR

Clomiphene Citrate

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin D

300.000 I.U single dose of VIT D IM injection

Intervention Type DRUG

Clomiphene Citrate

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Clomid

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1- BMI: more than 25.0 kg/m2

2- PCO was diagnosed by presence of 2 out of 3 criteria (according to ESHRE/ASRM in Rotterdam in 2003)

1. oligoovulation and/or an ovulation
2. excess androgen activity (clinical or biochemical)
3. polycystic ovaries (by pelvic ultrasound "vaginal route")

3- Anovulatory patient resistant to induction with clomiphene citrate alone