Comparing the Effect of Sitagliptin/Metformin and Metformin in PCOS Patients

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-10

Study Completion Date

2021-07-30

Brief Summary

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Investigators will evaluate and compare the efficacy of Sitagliptin/Metformin to metformin and sitagliptin on gdf9 and bmp15 gene expression on PCOS patients undergoing intracytoplasmic sperm injection(ICSI).

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Detailed Description

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This study was conducted in Infertility clinic of Mahdiyeh Educational Hospital, Tehran. Patients in the four groups receive the drug 2 months before the start of the ovulation cycle, and treatment will continue until the day of the oocyte aspiration. The drug provide by midwife to patients and both patient and physician blind to the treatment regimen. The participants randomly divide into four groups.The ovulation induction stimulate with GnRh antagonist.

Conditions

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Polycystic Ovary Syndrome Infertility ART

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Placebo

Control group: oral rehydration salts (ORS, Poursina, Tehran, Iran), two times daily

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Oral rehydration solution

Metformin

Intervention group 1: received Metformin (Glucophage, Merck, West Drayton, UK; 500 mg ,two times daily

Group Type EXPERIMENTAL

metformin

Intervention Type DRUG

metformin tablet

Sitagliptin

Intervention group2: received Sitagliptin (Januvia, Merck,West Drayton, UK. 50 mg, two times daily

Group Type EXPERIMENTAL

Sitagliptin

Intervention Type DRUG

Sitagliptin tablet

sitagliptin/metformin

Intervention group3: received Sitagliptin/metformin (Janumet, Merck,West Drayton, UK. 50/500 mg), two times daily

Group Type EXPERIMENTAL

Sitagliptin/metformin

Intervention Type DRUG

Sitagliptin/metformin tablet

Interventions

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placebo

Oral rehydration solution

Intervention Type DRUG

metformin

metformin tablet

Intervention Type DRUG

Sitagliptin

Sitagliptin tablet

Intervention Type DRUG

Sitagliptin/metformin

Sitagliptin/metformin tablet

Intervention Type DRUG

Other Intervention Names

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rehydration solution Glucophage JANUVIA JANUMET

Eligibility Criteria

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Inclusion Criteria

* subject has clinical or biochemical hyperandrogenic symptoms
* subject has oligo/amenorrhea cycles

Exclusion Criteria

* Hypersensitivity to metformin
* Hypersensitivity to sitagliptin presence of infertility factors other than anovulation,
* male infertility
* pelvic organic pathologies
* congenital adrenal hyperplasia
* thyroid dysfunction
* Cushing's syndrome
* hyper prolactinemia
* androgen secreting neoplasia
* diabetes mellitus
* consumption of medications affecting carbohydrate metabolism
* consumption hormonal analogues other than progesterone 2 months prior to enrolment in the study
* severe hepatic
* pancreatitis
* kidney diseases
* gallbladder diseases

Minimum Eligible Age

25 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No